ClinicalTrials.gov
ClinicalTrials.gov Menu

A Six-Week Flexible Dose Study Evaluating the Efficacy and Safety of Geodon in Patients With Bipolar I Depression.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00282464
Recruitment Status : Completed
First Posted : January 26, 2006
Results First Posted : June 2, 2009
Last Update Posted : June 3, 2009
Sponsor:
Information provided by:
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Bipolar Disorder
Interventions Drug: Placebo
Drug: Geodon (Ziprasidone)
Enrollment 392
Recruitment Details  
Pre-assignment Details 7 day washout: psychotropic drugs and lithium. 4 week washout: monoamine oxidase inhibitors. Depot neuroleptic DC'd 6 months before study entry.11 subjects assigned to but not treated with drug: 9 lost to follow up, 1 no longer willing to participate, 1 DC'd due to protocol violation
Arm/Group Title Ziprasidone 20-80mg Bid Placebo
Hide Arm/Group Description For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule). [Not Specified]
Period Title: Overall Study
Started 185 196
Completed 112 134
Not Completed 73 62
Reason Not Completed
Adverse Event             26             20
Lack of Efficacy             8             8
Lost to Follow-up             10             10
Withdrawal by Subject             24             10
laboratory abnormality             1             2
Protocol Violation             0             7
Patient moved             1             0
patient non-compliant             3             0
patient no show             0             1
patient incarcerated             0             1
family crisis             0             1
dispensed wrong kit             0             1
dropped due to missed visits             0             1
Arm/Group Title Ziprasidone 20-80mg Bid Placebo Total
Hide Arm/Group Description For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule). [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 185 196 381
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 185 participants 196 participants 381 participants
40.4  (12.5) 40.0  (11.7) 40.2  (12.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 185 participants 196 participants 381 participants
Female
108
  58.4%
111
  56.6%
219.0
Male
77
  41.6%
85
  43.4%
162.0
1.Primary Outcome
Title Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Hide Description Change is observed value at each visit minus baseline value. MADRS:10-item instrument measuring depression; scale range between 0(Normal) - 6(most abnormal)for each item. Total possible score is 0 - 60. Overall is average response Week 1 - Week 6.
Time Frame Baseline to Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Weeks 1 - 6 are Intent to treat (ITT) population Observed Cases.

Overall is Average of Weeks 1 - 6.

Arm/Group Title Ziprasidone 20-80mg Bid Placebo
Hide Arm/Group Description:
For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
[Not Specified]
Overall Number of Participants Analyzed 180 190
Least Squares Mean (Standard Error)
Unit of Measure: score on scale
Week 1 (n= 177, 189) -7.23  (0.79) -5.02  (0.71)
Week 2 (n=160, 176) -9.99  (0.79) -8.13  (0.72)
Week 3 (n=149, 163) -11.88  (0.83) -10.04  (0.83)
Week 4 (n=135, 153) -13.29  (0.92) -11.53  (0.85)
Week 5 (n=121, 146) -14.53  (0.95) -12.55  (0.88)
Week 6 (n=116, 141) -14.88  (1.02) -13.24  (0.92)
Overall (n= 180, 190) -11.97  (0.77) -10.09  (0.70)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Week 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments No multiple comparison adjustment is applicable. Statistical significance level was 0.05
Method Mixed Models Analysis
Comments Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.019
Comments [Not Specified]
Method Mixed Models Analysis
Comments Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Week 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.038
Comments [Not Specified]
Method Mixed Models Analysis
Comments Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.069
Comments [Not Specified]
Method Mixed Models Analysis
Comments Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Week 5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.053
Comments [Not Specified]
Method Mixed Models Analysis
Comments Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Week 6 An estimated sample size of 180 was needed per treatment arm in order to achieve 85% power to detect a treatment difference of 3.5 in the mean change from baseline to Week 6 in MADRS total score with a two-sided t-test at the 0.05 significance level. The common standard deviation was estimated as 11.0. The null hypotheses is equality of mean change from baseline to Week 6 in MADRS total score between ziprasidone and placebo groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.154
Comments [Not Specified]
Method Mixed Models Analysis
Comments Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Overall
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments [Not Specified]
Method Mixed Models Analysis
Comments Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value
2.Secondary Outcome
Title Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Rating Scale (MADRS) Total Score
Hide Description Participants with MADRS Total Score greater than or equal to 50 percent decrease from baseline responded yes; others responded no. MADRS: 10-item instrument measuring depression; scale 0(Normal) & 6 (most abnormal)for each item. Total possible score is 0 - 60. Endpoint is last observation carried forward (LOCF)
Time Frame Baseline to Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Weeks 1 - 6 are Intent to treat (ITT) population Observed Cases

Not all subjects responded at each week.

Endpoint is ITT population Last Observation Carried Forward (LOCF)

Arm/Group Title Ziprasidone 20-80mg Bid Placebo
Hide Arm/Group Description:
For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
[Not Specified]
Overall Number of Participants Analyzed 180 190
Measure Type: Number
Unit of Measure: participants
Week 1: Yes 40 24
Week 1: No 137 168
Week 2: Yes 55 48
Week 2: No 105 128
Week 3: Yes 71 60
Week 3: No 78 105
Week 4: Yes 76 66
Week 4: No 59 87
Week 5: Yes 81 77
Week 5: No 40 69
Week 6: Yes 76 83
Week 6: No 40 58
Endpoint: Yes 95 97
Endpoint: No 85 93
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Week 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0056
Comments For all secondary efficacy analyses, no multiple comparison adjustment were made
Method Cochran-Mantel-Haenszel
Comments CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0866
Comments For all secondary efficacy analyses, no multiple comparison adjustment were made
Method Cochran-Mantel-Haenszel
Comments CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Week 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0568
Comments For all secondary efficacy analyses, no multiple comparison adjustment were made.
Method Cochran-Mantel-Haenszel
Comments CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0130
Comments For all secondary efficacy analyses, no multiple comparison adjustment were made.
Method Cochran-Mantel-Haenszel
Comments CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Week 5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0188
Comments For all secondary efficacy analyses, no multiple comparison adjustment were made
Method Cochran-Mantel-Haenszel
Comments CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6394
Comments For all secondary efficacy analyses, no multiple comparison adjustment were made
Method Cochran-Mantel-Haenszel
Comments CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Endpoint
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7707
Comments For all secondary efficacy analyses, no multiple comparison adjustment were made
Method Cochran-Mantel-Haenszel
Comments CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups
3.Secondary Outcome
Title Response Greater Than or Equal to 50 Percent Decrease From Baseline in Hamilton Depression Rating Scale (HAM-D 17) Total Score
Hide Description Participants with greater than or equal to 50 percent decrease from baseline in HAM-D 17 total score responded yes; others responded no. Total score is first 17 items of the HAM-D 25: measures range of depressive symptoms. Scale: 8 items 0-2 & 9 items 0-4, higher scores being more severe. Total possible score is 0 - 52. Endpoint is LOCF.
Time Frame Baseline to Week 3, Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Weeks 3, 6 are Intent to treat (ITT) population Observed Cases.

Not all subjects responded at each week.

Endpoint is ITT population Last Observation Carried Forward (LOCF)

Arm/Group Title Ziprasidone 20-80mg Bid Placebo
Hide Arm/Group Description:
For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
[Not Specified]
Overall Number of Participants Analyzed 180 190
Measure Type: Number
Unit of Measure: Participants
Week 3: Yes 72 65
Week 3: No 95 112
Week 6: Yes 85 91
Week 6: No 41 59
Endpoint: Yes 95 97
Endpoint: No 73 84
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Week 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2185
Comments For all secondary efficacy analyses, no multiple comparison adjustment were made
Method Cochran-Mantel-Haenszel
Comments CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4124
Comments For all secondary efficacy analyses, no multiple comparison adjustment were made
Method Cochran-Mantel-Haenszel
Comments CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Endpoint
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6098
Comments For all secondary efficacy analyses, no multiple comparison adjustment were made
Method Cochran-Mantel-Haenszel
Comments CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups
4.Secondary Outcome
Title Remission as Measured by Montgomery Asberg Depression Scale (MADRS) Total Score Less Than or Equal to 12
Hide Description Remission response is yes if MADRS total score less than or equal to 12; if not, response is no. MADRS: 10-item instrument measuring depression; scale 0(Normal) & 6(most abnormal).Total possible score is 0 - 60. Endpoint is LOCF.
Time Frame Week 1 to Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Weeks 1 - 6 are Intent to treat (ITT) population Observed Cases.

Not all subjects responded at each week.

Endpoint is ITT population Last Observation Carried Forward (LOCF)

Arm/Group Title Ziprasidone 20-80mg Bid Placebo
Hide Arm/Group Description:
For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
[Not Specified]
Overall Number of Participants Analyzed 180 190
Measure Type: Number
Unit of Measure: Participants
Week 1: Yes 41 21
Week 1: No 136 168
Week 2: Yes 54 41
Week 2: No 106 135
Week 3: Yes 70 58
Week 3: No 79 105
Week 4: Yes 66 60
Week 4: No 69 93
Week 5: Yes 70 66
Week 5: No 51 80
Week 6: Yes 70 72
Week 6: No 46 69
Endpoint: Yes 87 81
Endpoint: No 93 109
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Week 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments For all secondary efficacy analyses, no multiple comparison adjustment were made
Method Cochran-Mantel-Haenszel
Comments CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0099
Comments For all secondary efficacy analyses, no multiple comparison adjustment were made
Method Cochran-Mantel-Haenszel
Comments CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Week 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0423
Comments For all secondary efficacy analyses, no multiple comparison adjustment were made
Method Cochran-Mantel-Haenszel
Comments CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0618
Comments For all secondary efficacy analyses, no multiple comparison adjustment were made
Method Cochran-Mantel-Haenszel
Comments CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Week 5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0451
Comments For all secondary efficacy analyses, no multiple comparison adjustment were made
Method Cochran-Mantel-Haenszel
Comments CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2633
Comments For all secondary efficacy analyses, no multiple comparison adjustment were made
Method Cochran-Mantel-Haenszel
Comments CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Endpoint
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2206
Comments For all secondary efficacy analyses, no multiple comparison adjustment were made
Method Cochran-Mantel-Haenszel
Comments CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups
5.Secondary Outcome
Title Remission as Measured by Hamilton Asberg Depression Rating Scale (HAM-D 17) Total Score Less Than or Equal to 7
Hide Description Remission response is yes when HAM-D 17 total score is less than or equal to 7; if not, response is no. Total score is first 17 items of HAM-D 25, measures range of depressive symptoms. Scale: 8 items 0-2 and 9 items 0-4, higher scores more severe. Total possible score is 0 - 52. Endpoint is LOCF.
Time Frame Week 3, Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Weeks 3, 6 are Intent to treat (ITT) population Observed Cases.

Not all subjects responded at each week.

Endpoint is ITT population Last Observation Carried Forward (LOCF)

Arm/Group Title Ziprasidone 20-80mg Bid Placebo
Hide Arm/Group Description:
For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
[Not Specified]
Overall Number of Participants Analyzed 180 190
Measure Type: Number
Unit of Measure: Participants
Week 3: Yes 32 33
Week 3: No 135 144
Week 6: Yes 56 51
Week 6: No 70 99
Endpoint: Yes 59 55
Endpoint: No 109 126
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Week 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9863
Comments For all secondary efficacy analyses, no multiple comparison adjustment were made
Method Cochran-Mantel-Haenszel
Comments CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1017
Comments For all secondary efficacy analyses, no multiple comparison adjustment were made
Method Cochran-Mantel-Haenszel
Comments CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Endpoint
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4033
Comments For all secondary efficacy analyses, no multiple comparison adjustment were made
Method Cochran-Mantel-Haenszel
Comments CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups
6.Secondary Outcome
Title Change in Hamilton Depression Rating Scale (HAM-D 17) Total Score
Hide Description Change is observed value at each visit minus baseline value. HAM-D 17 Total score is first 17 items of HAM-D 25; measures range of depressive symptoms patient currently experiencing. Scale: 8 items 0-2 & 9 items 0-4; 0=absent or not depressed, 2 or 4=most severe or extreme. Total possible score is 0 - 52.Endpoint is LOCF
Time Frame Baseline to Weeks 3, 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Weeks 3, 6 are Intent to Treat (ITT) population Observed Cases.

Endpoint is ITT population Last Observation Carried Forward (LOCF).

Arm/Group Title Ziprasidone 20-80mg Bid Placebo
Hide Arm/Group Description:
For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
[Not Specified]
Overall Number of Participants Analyzed 180 190
Least Squares Mean (Standard Error)
Unit of Measure: score on scale
Week 3 (n=167, 177) -9.91  (0.88) -8.73  (0.84)
Week 6 (n=126, 150) -12.91  (1.15) -12.07  (1.06)
Endpoint (n=168, 181) -6.92  (1.36) -7.11  (1.30)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Week 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.112
Comments For all efficacy analyses, no multiple comparisons adjustments were made
Method ANCOVA
Comments ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.352
Comments For all efficacy analyses, no multiple comparisons adjustments were made
Method ANCOVA
Comments ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Endpoint
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.873
Comments For all efficacy analyses, no multiple comparisons adjustments were made
Method ANCOVA
Comments ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.
7.Secondary Outcome
Title Change in Total Score in Hamiliton Depression Rating Scale (HAM-D 25)
Hide Description Change is observed value at each visit minus baseline value. HAM-D: 25-item instrument measuring the range of depressive symptoms patient currently experiencing. Scale: 14 items 0-2 & 11 items 0-4; 0=absent or not depressed, 2 or 4=most severe or extreme. Total possible score is 0 - 72. Endpoint is LOCF.
Time Frame Baseline to Weeks 3, 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Weeks 3, 6 are Intent to Treat (ITT) population Observed Cases.

Endpoint is ITT population Last Observation Carried Forward (LOCF).

Arm/Group Title Ziprasidone 20-80mg Bid Placebo
Hide Arm/Group Description:
For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
[Not Specified]
Overall Number of Participants Analyzed 180 190
Least Squares Mean (Standard Error)
Unit of Measure: score on scale
Week 3 (n=167, 177) -11.68  (1.07) -10.76  (1.02)
Week 6 (n=126, 150) -15.48  (1.32) -14.80  (1.22)
Endpoint (n=168, 181) -8.06  (1.64) -8.58  (1.56)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Week 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.305
Comments For all efficacy analyses, no multiple comparisons adjustments were made
Method ANCOVA
Comments ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.510
Comments For all efficacy analyses, no multiple comparisons adjustments were made.
Method ANCOVA
Comments ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Endpoint
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.710
Comments For all efficacy analyses, no multiple comparisons adjustments were made
Method ANCOVA
Comments ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.
8.Secondary Outcome
Title Change in Bech Melancholia Score
Hide Description Change is observed value at each visit minus baseline value. Bech Melancholia is sum of scores on 6 Items pertaining to melancholia within HAM-D. Scale range 0 to 4; higher scores, greater severity. Total possible score is 0 - 24. Endpoint is LOCF.
Time Frame Baseline to Weeks 3, 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Weeks 3, 6 are Intent to Treat(ITT) population Observed Cases.

Endpoint is ITT population Last Observation Carried Forward (LOCF).

Arm/Group Title Ziprasidone 20-80mg Bid Placebo
Hide Arm/Group Description:
For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
[Not Specified]
Overall Number of Participants Analyzed 180 190
Least Squares Mean (Standard Error)
Unit of Measure: score on scale
Week 3 (n =167, 177) -5.22  (0.50) -4.28  (0.48)
Week 6 (n =126, 150) -6.82  (0.65) -6.20  (0.6)
Endpoint (n =168, 181) -3.73  (0.75) -3.61  (0.71)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Week 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.026
Comments For all efficacy analyses, no multiple comparisons adjustments were made
Method ANCOVA
Comments ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.223
Comments For all efficacy analyses, no multiple comparisons adjustments were made
Method ANCOVA
Comments ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Endpoint
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.848
Comments For all efficacy analyses, no multiple comparisons adjustments were made
Method ANCOVA
Comments ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.
9.Secondary Outcome
Title Change in Anxiety/Somatizations Factor Total Score
Hide Description Change is observed value at each visit minus baseline value. This test is sum of Scores on 6 Items pertaining to anxiety/somatization within HAM-D. Scale range 0 to 4 with higher scores reflecting greater severity. Total possible score is 0 - 24. Endpoint is LOCF.
Time Frame Baseline to Weeks 3, 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Weeks 3, 6 are Intent to treat (ITT) population Observed Cases.

Endpoint is ITT population Last Observation Carried Forward (LOCF).

Arm/Group Title Ziprasidone 20-80mg Bid Placebo
Hide Arm/Group Description:
For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
[Not Specified]
Overall Number of Participants Analyzed 180 190
Least Squares Mean (Standard Error)
Unit of Measure: score on scale
Week 3 (n =167, 177) -2.84  (0.31) -2.61  (0.30)
Week 6 (n =126, 150) -4.09  (0.37) -3.96  (0.35)
Endpoint (n =168, 181) -2.18  (0.43) -2.57  (0.41)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Week 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.381
Comments For all efficacy analyses, no multiple comparisons adjustments were made
Method ANCOVA
Comments ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.676
Comments For all efficacy analyses, no multiple comparisons adjustments were made
Method ANCOVA
Comments ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Endpoint
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.295
Comments For all secondary efficacy analyses, no multiple comparison adjustment were made
Method ANCOVA
Comments ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.
10.Secondary Outcome
Title Change in Retardation Factor Scores
Hide Description Change is observed value at each visit minus baseline value. Retardation Factor is the sum of scores of 4 items which pertain to retardation within HAM-D. Scores 0 to 4, higher scores reflecting greater severity.Total possible score is 0 - 16. Endpoint is LOCF.
Time Frame Baseline to Weeks 3, 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Weeks 3, 6 are Intent to treat (ITT) population Observed Cases.

Endpoint is ITT population Last Observation Carried Forward (LOCF).

Arm/Group Title Ziprasidone 20-80mg Bid Placebo
Hide Arm/Group Description:
For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
[Not Specified]
Overall Number of Participants Analyzed 180 190
Least Squares Mean (Standard Error)
Unit of Measure: score on scale
Week 3 (n =167, 177) -3.22  (0.35) -2.68  (0.34)
Week 6 (n =126, 150) -4.38  (0.45) -3.66  (0.42)
Endpoint (n =168, 181) -2.24  (0.50) -1.88  (0.48)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Week 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.068
Comments For all efficacy analyses, no multiple comparisons adjustments were made
Method ANCOVA
Comments ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.043
Comments For all efficacy analyses, no multiple comparisons adjustments were made
Method ANCOVA
Comments ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Endpoint
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.404
Comments For all efficacy analyses, no multiple comparisons adjustments were made
Method ANCOVA
Comments ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.
11.Secondary Outcome
Title Change in Sleep Disturbance Factor Score
Hide Description Change is observed value at each visit minus baseline value. Sleep Disturbance is the sum of scores of 3 items which pertain to sleep disturbance within Hamilton Depression Rating Scale (HAM-D). Scale range 0 to 4 with higher scores reflecting greater severity. Total possible score is 0 - 12.
Time Frame Baseline to Weeks 3, 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Weeks 3, 6 are Intent to treat (ITT) population Observed Cases.

Endpoint is ITT population Last Observation Carried Forward (LOCF)

Arm/Group Title Ziprasidone 20-80mg Bid Placebo
Hide Arm/Group Description:
For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
[Not Specified]
Overall Number of Participants Analyzed 180 190
Least Squares Mean (Standard Error)
Unit of Measure: score on scale
Week 3 (n =167, 177) -1.51  (0.24) -1.48  (0.23)
Week 6 (n =126, 150) -2.38  (0.28) -2.31  (0.26)
Endpoint (n=168, 181) -1.19  (0.30) -1.26  (0.29)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Week 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.899
Comments For all secondary efficacy analyses, no multiple comparison adjustment were made
Method ANCOVA
Comments ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.739
Comments For all secondary efficacy analyses, no multiple comparison adjustment were made
Method ANCOVA
Comments ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Endpoint
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.797
Comments For all secondary efficacy analyses, no multiple comparison adjustment were made
Method ANCOVA
Comments ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.
12.Secondary Outcome
Title Change in Hamilton Anxiety Rating (HAM-A)
Hide Description Change is observed value at each visit minus baseline value. HAM-A:14-item scale to rate the intensity of psychic anxiety (items 1- 6, 14) and somatic anxiety (items 7-13) on a 5-point severity scale (0=not present to 4=very severe). Total possible score is 0 - 56.
Time Frame Baseline to Weeks 3, 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Weeks 3, 6 are Intent to treat (ITT) population Observed Cases.

Endpoint is ITT population Last Observation Carried Forward (LOCF).

Arm/Group Title Ziprasidone 20-80mg Bid Placebo
Hide Arm/Group Description:
For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
[Not Specified]
Overall Number of Participants Analyzed 180 190
Least Squares Mean (Standard Error)
Unit of Measure: score on scale
Week 3 (n=167, 177) -4.63  (0.69) -4.18  (0.66)
Week 6 (n=126, 150) -6.84  (0.91) -6.64  (0.84)
Endpoint (n=168, 181) -3.05  (1.06) -3.26  (1.01)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Week 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.434
Comments For all secondary efficacy analyses, no multiple comparison adjustment were made
Method ANCOVA
Comments ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.777
Comments For all secondary efficacy analyses, no multiple comparison adjustment were made
Method ANCOVA
Comments ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Endpoint
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.820
Comments For all secondary efficacy analyses, no multiple comparison adjustment were made
Method ANCOVA
Comments ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.
13.Secondary Outcome
Title Change in Total Score of Young Mania Rating Scale (YMRS)
Hide Description Change is observed value at each visit minus baseline value. YMRS: 11 item instrument with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0=normal; 4 or 8=most abnormal. Total possible score is 0 - 60. Overall is average response Week 1 - 6.
Time Frame Baseline to week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Week 1 - Week 6 is Intent to treat (ITT) population Observed Cases.

Overall is Average of Weeks 1 – 6.

Arm/Group Title Ziprasidone 20-80mg Bid Placebo
Hide Arm/Group Description:
For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
[Not Specified]
Overall Number of Participants Analyzed 180 190
Least Squares Mean (Standard Error)
Unit of Measure: score on scale
Week 1 (n=177, 189) 0.40  (0.36) 0.69  (0.33)
Week 2 (n=160, 176) 0.49  (0.39) -0.13  (0.31)
Week 3 (n=149, 163) -0.13  (0.41) 0.00  (0.34)
Week 4 (n=135, 153) -0.60  (0.36) -0.77  (0.31)
Week 5 (n=121, 146) -0.94  (0.35) -0.77  (0.31)
Week 6 (n=116, 141) -0.45  (0.43) -0.66  (0.37)
Overall (n=180, 190) -0.20  (0.32) -0.27  (0.26)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Week 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.468
Comments For all secondary efficacy analyses, no multiple comparison adjustment were made
Method Mixed Models Analysis
Comments Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.110
Comments For all secondary efficacy analyses, no multiple comparison adjustment were made
Method Mixed Models Analysis
Comments Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Week 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.738
Comments For all secondary efficacy analyses, no multiple comparison adjustment were made
Method Mixed Models Analysis
Comments Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.617
Comments For all secondary efficacy analyses, no multiple comparison adjustment were made
Method Mixed Models Analysis
Comments Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Week 5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.642
Comments For all secondary efficacy analyses, no multiple comparison adjustment were made
Method Mixed Models Analysis
Comments Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.644
Comments For all secondary efficacy analyses, no multiple comparison adjustment were made
Method Mixed Models Analysis
Comments Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Overall
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.789
Comments For all secondary efficacy analyses, no multiple comparison adjustment were made
Method Mixed Models Analysis
Comments Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value
14.Secondary Outcome
Title Change in Global Clinical Severity of Symptoms (CGI-S)
Hide Description Change is observed value at each visit minus baseline value. CGI-S is an instrument to measure severity of mental illness. Scale range: 0 = not assessed, 1 = normal, 7 = among most extremely ill
Time Frame Baseline to week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Week 1 - Week 6 is Intent to treat (ITT) population Observed Cases.

Overall is Average of Weeks 1 – 6.

Arm/Group Title Ziprasidone 20-80mg Bid Placebo
Hide Arm/Group Description:
For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
[Not Specified]
Overall Number of Participants Analyzed 180 190
Least Squares Mean (Standard Error)
Unit of Measure: score on scale
Week 1 (n=177, 188) -0.39  (0.08) -0.25  (0.07)
Week 2 (n=160, 176) -0.66  (0.08) -0.51  (0.08)
Week 3 (n=149, 163) -0.88  (0.10) -0.84  (0.09)
Week 4 (n=135, 152) -1.03  (0.11) -0.98  (0.10)
Week 5 (n=121, 146) -1.27  (0.11) -1.15  (0.10)
Week 6 (n=116, 140) -1.34  (0.11) -1.28  (0.11)
Overall (n=180, 190) -0.93  (0.08) -0.84  (0.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Week 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.042
Comments For all secondary efficacy analyses, no multiple comparison adjustment were made
Method Mixed Models Analysis
Comments Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.088
Comments For all secondary efficacy analyses, no multiple comparison adjustment were made
Method Mixed Models Analysis
Comments Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Week 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.651
Comments For all secondary efficacy analyses, no multiple comparison adjustment were made
Method Mixed Models Analysis
Comments Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.665
Comments For all secondary efficacy analyses, no multiple comparison adjustment were made
Method Mixed Models Analysis
Comments Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Week 5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.349
Comments For all secondary efficacy analyses, no multiple comparison adjustment were made
Method Mixed Models Analysis
Comments Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.685
Comments For all secondary efficacy analyses, no multiple comparison adjustment were made
Method Mixed Models Analysis
Comments Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Overall
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.257
Comments For all secondary efficacy analyses, no multiple comparison adjustment were made
Method Mixed Models Analysis
Comments Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value
15.Secondary Outcome
Title Change in Global Clinical Improvement of Symptoms (CGI -I)
Hide Description Change is observed value at each visit minus baseline value. CGI-I is an instrument for Global assessment of improvement in patient's condition. Scale range:0=not assessed, 1=very much improved, 7=very much worse
Time Frame Baseline to Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Week 1 - Week 6 is Intent to treat (ITT) population Observed Cases.

Overall is Average of Weeks 1 – 6.

Arm/Group Title Ziprasidone 20-80mg Bid Placebo
Hide Arm/Group Description:
For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
[Not Specified]
Overall Number of Participants Analyzed 180 190
Least Squares Mean (Standard Error)
Unit of Measure: score on scale
Week 1 (n=177, 188) 3.37  (0.10) 3.61  (0.10)
Week 2 (n=160, 176) 3.09  (0.11) 3.29  (0.11)
Week 3 (n=149, 163) 2.89  (0.12) 3.04  (0.11)
Week 4 (n=135, 152) 2.74  (0.12) 2.94  (0.11)
Week 5 (n=121, 146) 2.61  (0.13) 2.84  (0.12)
Week 6 (n=116, 140) 2.52  (0.13) 2.64  (0.12)
Overall (n=180, 190) 2.87  (0.10) 3.06  (0.10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Week 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0099
Comments For all secondary efficacy analyses, no multiple comparison adjustment were made
Method Mixed Models Analysis
Comments Fixed categorical effect: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0654
Comments For all secondary efficacy analyses, no multiple comparison adjustment were made
Method Mixed Models Analysis
Comments Fixed categorical effect: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Week 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1807
Comments For all secondary efficacy analyses, no multiple comparison adjustment were made
Method Mixed Models Analysis
Comments Fixed categorical effect: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0957
Comments For all secondary efficacy analyses, no multiple comparison adjustment were made
Method Mixed Models Analysis
Comments Fixed categorical effect: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Week 5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0752
Comments For all secondary efficacy analyses, no multiple comparison adjustment were made
Method Mixed Models Analysis
Comments Fixed categorical effect: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3964
Comments For all secondary efficacy analyses, no multiple comparison adjustment were made
Method Mixed Models Analysis
Comments Fixed categorical effect: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Overall
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0287
Comments For all secondary efficacy analyses, no multiple comparison adjustment were made
Method Mixed Models Analysis
Comments Fixed categorical effect: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction.
16.Secondary Outcome
Title Change in Global Assessment of Functioning (GAF)
Hide Description Change is observed value at each visit minus baseline value. GAF is an instrument used to assess global psychological, social, & occupational functioning. Scale range: 100 = normal and 0 = greatest abnormality.
Time Frame Baseline to week 6 (Endpoint)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Endpoint is ITT population Last Observation Carried Forward (LOCF). n = 154, 169; N = 180, 190
Arm/Group Title Ziprasidone 20-80mg Bid Placebo
Hide Arm/Group Description:
For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
[Not Specified]
Overall Number of Participants Analyzed 154 169
Least Squares Mean (Standard Error)
Unit of Measure: score on scale
9.59  (1.52) 9.53  (1.42)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Change from baseline to endpoint
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.965
Comments For all secondary efficacy analyses, no multiple comparison adjustment were made
Method ANCOVA
Comments ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.
17.Secondary Outcome
Title Change in Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q) Total Score
Hide Description Change is observed value at each visit minus baseline value. Q-LES-Q: 16- item instrument for a patient's assessment of his/her quality of life. Scale range: overall level of satisfaction 1=very poor to 5=Very good. 1 item (medication)can be left blank. Total possible score 15 - 80.
Time Frame Baseline to week 6 (endpoint)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Change from baseline to Endpoint. Endpoint is Intent to Treat (ITT) population Last Observation Carried Forward (LOCF). n = 153, 168; N = 180, 190
Arm/Group Title Ziprasidone 20-80mg Bid Placebo
Hide Arm/Group Description:
For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
[Not Specified]
Overall Number of Participants Analyzed 153 168
Least Squares Mean (Standard Error)
Unit of Measure: score on scale
0.06  (0.02) 0.06  (0.01)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Change from baseline to endpoint
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.860
Comments For all secondary efficacy analyses, no multiple comparison adjustment were made
Method ANCOVA
Comments ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.
18.Secondary Outcome
Title Change in Sheehan Disability Scale (SDS) Total Score
Hide Description Change is observed value at each visit minus baseline value. SDS is a patient rated measure of disability and impairment in work/school, social life, family life/home responsibilities. Scale range: 0-10 with 0=no disruption,10=extreme disruption. Total possible score is 0 - 30.
Time Frame Baseline to week 6 (endpoint)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Baseline to Endpoint. Endpoint is ITT population Last Observation Carried Forward (LOCF). n = 149, 162; N = 180, 190
Arm/Group Title Ziprasidone 20-80mg Bid Placebo
Hide Arm/Group Description:
For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
[Not Specified]
Overall Number of Participants Analyzed 149 162
Least Squares Mean (Standard Error)
Unit of Measure: score on scale
-3.69  (0.93) -3.05  (0.91)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Baseline to endpoint
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.428
Comments For all secondary efficacy analyses, no multiple comparison adjustment were made
Method ANCOVA
Comments ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.
19.Secondary Outcome
Title Change in Bipolar Cognition Rating Scale (BPCoRS) Interviewer Global Rating of Subject
Hide Description Change is observed value at each visit minus baseline value. BPCoRs: Subject interview with 20-items measuring cognitive deficits & degree of affect on functioning. Scale range:0 to 4, higher numbers, greater impairment. Total possible score is 0 - 80. Endpoint=last observation carried forward (LOCF)
Time Frame Baseline to week 6 (endpoint)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Baseline to Endpoint. Endpoint is Intent to Treat (ITT) population Last Observation Carried Forward (LOCF). n = 141, 164; N = 180, 190
Arm/Group Title Ziprasidone 20-80mg Bid Placebo
Hide Arm/Group Description:
For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
[Not Specified]
Overall Number of Participants Analyzed 141 164
Least Squares Mean (Standard Error)
Unit of Measure: score on scale
-0.65  (0.24) -0.73  (0.22)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Change from baseline to endpoint
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.708
Comments For all secondary efficacy analyses, no multiple comparison adjustment were made
Method ANOVA
Comments ANOVA model included effects of treatment, rapid cycling, center and prior hospitalization status
20.Secondary Outcome
Title Change in Bipolar Cognition Rating Scale (BPCoRS) Informant Global Rating
Hide Description Change is observed value at each visit minus baseline value. Informant Global Rating is interview with informant of subject using BPCoRS, a 20-item instrument measuring cognitive deficits & degree of affect on functioning. Scale: 0 to 4, higher numbers = greater impairment. Total possible score is 0 - 80. Endpoint is LOCF.
Time Frame Baseline to week 6 (endpoint)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Baseline to Endpoint. Endpoint is ITT population Last Observation Carried Forward (LOCF). n = 97, 104; N = 180, 190
Arm/Group Title Ziprasidone 20-80mg Bid Placebo
Hide Arm/Group Description:
For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
[Not Specified]
Overall Number of Participants Analyzed 97 104
Least Squares Mean (Standard Error)
Unit of Measure: score on scale
4.66  (0.21) 4.68  (0.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Endpoint
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.898
Comments For all secondary efficacy analyses, no multiple comparison adjustment were made
Method ANOVA
Comments ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.
21.Secondary Outcome
Title Change in Bipolar Cognition Rating Scale (BPCoRS) Global Rating by Interviewer
Hide Description Change in Rating by interviewer, using BPCoRS, 20-item instrument measuring cognitive deficits and the degree of affect on functioning; 4 point scale with higher numbers reflecting greater impairment.Total possible score is 0 - 80.
Time Frame Baseline to week 6 (endpoint)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Endpoint is Intent to Treat (ITT) population Last Observation Carried Forward (LOCF). n = 137, 158; N = 180, 190
Arm/Group Title Ziprasidone 20-80mg Bid Placebo
Hide Arm/Group Description:
For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
[Not Specified]
Overall Number of Participants Analyzed 137 158
Least Squares Mean (Standard Error)
Unit of Measure: score on scale
4.72  (0.18) 4.63  (0.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Endpoint
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.559
Comments For all secondary efficacy analyses, no multiple comparison adjustment were made
Method ANOVA
Comments ANOVA model included effects of treatment, rapid cycling, center and prior hospitalization status.
22.Secondary Outcome
Title Change in Bipolar Cognition Rating Scale (BPCoRS) Subject Rating at Endpoint
Hide Description Change is observed value at each visit minus baseline value. Subject Rating: Subject's perceived change in status using a 20-item instrument measuring cognitive deficits and degree of affect on funtioning. Scale 0 to 4, higher numbers reflecting greater impairment. Total possible score is 0 - 80. Endpoint is last observation carried forward.
Time Frame Baseline to Week 6 (endpoint)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Endpoint is Intent to Treat (ITT) Last Observation Carried Forward (LOCF). n = 140, 162; N = 180, 190
Arm/Group Title Ziprasidone 20-80mg Bid Placebo
Hide Arm/Group Description:
For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
[Not Specified]
Overall Number of Participants Analyzed 140 162
Least Squares Mean (Standard Error)
Unit of Measure: score on scale
4.69  (0.19) 4.81  (0.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ziprasidone 20-80mg Bid, Placebo
Comments Endpoint
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.458
Comments For all secondary efficacy analyses, no multiple adjustments were made
Method ANOVA
Comments ANVOVA model included effects of treatment, rapid cycling, center and prior hospitalization status.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ziprasidone 20-80mg Bid Placebo
Hide Arm/Group Description For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule). [Not Specified]
All-Cause Mortality
Ziprasidone 20-80mg Bid Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ziprasidone 20-80mg Bid Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   3   4 
Injury, poisoning and procedural complications     
Skin laceration  1  0/185 (0.00%)  1/196 (0.51%) 
Psychiatric disorders     
Bipolar disorder   0/185 (0.00%)  1/196 (0.51%) 
Psychotic disorder   0/185 (0.00%)  1/196 (0.51%) 
Suicidal ideation   2/185 (1.08%)  1/196 (0.51%) 
Suicide attempt   1/185 (0.54%)  0/196 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (v11.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ziprasidone 20-80mg Bid Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   93   73 
Gastrointestinal disorders     
Diarrhoea  1  8/185 (4.32%)  15/196 (7.65%) 
Nausea   11/185 (5.95%)  21/196 (10.71%) 
General disorders     
Fatigue   13/185 (7.03%)  8/196 (4.08%) 
Nervous system disorders     
Dizziness   12/185 (6.49%)  10/196 (5.10%) 
Headache   21/185 (11.35%)  21/196 (10.71%) 
Sedation   22/185 (11.89%)  6/196 (3.06%) 
Somnolence   25/185 (13.51%)  5/196 (2.55%) 
Psychiatric disorders     
Depression   6/185 (3.24%)  13/196 (6.63%) 
Insomnia   9/185 (4.86%)  10/196 (5.10%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (v11.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of <60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), <12 mo from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer Inc.
Phone: 1-800-718-1021
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00282464     History of Changes
Other Study ID Numbers: A1281139
First Submitted: January 24, 2006
First Posted: January 26, 2006
Results First Submitted: March 3, 2009
Results First Posted: June 2, 2009
Last Update Posted: June 3, 2009