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Trial record 26 of 134 for:    "Depressive Disorder" [DISEASE] | ( Map: Arkansas, United States )

Adjunctive Ziprasidone in the Treatment of 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: NCT00483548
Recruitment Status : Completed
First Posted : June 7, 2007
Results First Posted : February 23, 2010
Last Update Posted : February 23, 2010
Sponsor:
Information provided by:
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Bipolar Disorder
Depression, Bipolar
Interventions Drug: Ziprasidone
Drug: Placebo
Enrollment 298
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ziprasidone Placebo
Hide Arm/Group Description Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine). Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
Period Title: Overall Study
Started 148 150
Received Study Treatment 147 [1] 147 [2]
Completed 88 104
Not Completed 60 46
Reason Not Completed
Randomized; not treated with study drug             1             3
Adverse Event             25             14
Laboratory abnormality             1             2
Lack of Efficacy             4             8
Protocol Violation             11             7
Pregnancy             1             0
Protocol required discontinuation             6             6
Unable to comply with protocol schedule             1             0
Non-compliance with medication             2             0
Lost to Follow-up             3             4
Withdrawal by Subject             5             2
[1]
1 subject randomized but lost to follow up; no treatment data.
[2]
3 subjects randomized but not treated.
Arm/Group Title Ziprasidone Placebo Total
Hide Arm/Group Description Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine). Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine). Total of all reporting groups
Overall Number of Baseline Participants 147 147 294
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 147 participants 147 participants 294 participants
Between 18 and 65 years 147 146 293
>65 years 0 1 1
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 147 participants 147 participants 294 participants
Female
89
  60.5%
91
  61.9%
180
  61.2%
Male
58
  39.5%
56
  38.1%
114
  38.8%
1.Primary Outcome
Title Change From Baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Hide Description MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts); rated on a 7-point Likert scale 0 (normal) to 6 (most abnormal); total score 0 to 44 (higher score indicates greater severity of symptoms). Change calculated as a difference between post-baseline observation and baseline MADRS score values.
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat analysis set (ITT): all randomized subjects who received at least 1 dose of double-blind treatment and had at least 1 post-baseline primary efficacy evaluation.
Arm/Group Title Ziprasidone Placebo
Hide Arm/Group Description:
Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
Overall Number of Participants Analyzed 145 145
Mean (Standard Deviation)
Unit of Measure: scores on scale
-14.7  (10.7) -13.2  (10.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ziprasidone, Placebo
Comments N=141 per arm (282 total) needed for 85% power for 2-sided alpha=0.05 based on true mean difference=4.0 and standard deviation (SD)=11.0 for primary endpoint. Interim Analysis (IA) planned when 60% of subjects had completed study or discontinued prematurely to assess efficacy (nominal 2-sided p-value less than or equal to [≤] 0.0076) or futility (nominal 2-sided p-value greater than or equal to [≥] 0.5099).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7921
Comments Due to planned interim analysis of primary endpoint, to control type I error at 2-sided alpha=0.05, a nominal 2-sided p-value ≤0.0476 needed at final analysis to reject the null hypothesis of no treatment effect.
Method ANCOVA Mixed-effects repeated-measures
Comments No other adjustment made for multiple comparisons since all comparisons, except for single primary comparison, are considered secondary.
Method of Estimation Estimation Parameter Least squares mean
Estimated Value -0.36
Confidence Interval 95%
-3.07 to 2.34
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.37
Estimation Comments Mixed-effects repeated-measures (MMRM) analysis of covariance model: fixed categorical effects of treatment, country, mood stabilizer type, visit, treatment-by-visit interaction, fixed continuous effect of baseline value and subject as random effect.
2.Secondary Outcome
Title Change From Baseline to Week 6 in Clinical Global Impression - Severity Scale (CGI-Severity or CGI-S)
Hide Description CGI-S is a single-item clinician rated scale used to assess global severity of bipolar illness based on an overall evaluation of symptoms of bipolar mania, associated behavioral symptoms, and condition of the subject. Scored from 1 (normal, not at all ill) to 7 (among the most severely ill subjects). Higher score = more affected. Change calculated as a difference between post-baseline observation and baseline CGI-S score values.
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Ziprasidone Placebo
Hide Arm/Group Description:
Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
Overall Number of Participants Analyzed 145 145
Mean (Standard Deviation)
Unit of Measure: scores on scale
-1.5  (1.3) -1.5  (1.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ziprasidone, Placebo
Comments Week 6; MMRM analysis of covariance model with fixed categorical effects of treatment, country, type of mood stabilizer, visit, treatment-by-visit interaction, fixed continuous effect of baseline value and subject as random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7223
Comments [Not Specified]
Method ANCOVA Mixed-effects repeated-measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean
Estimated Value 0.06
Confidence Interval 95%
-0.25 to 0.36
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.16
Estimation Comments [Not Specified]
3.Secondary Outcome
Title MADRS Remission: Number of Subjects With Total MADRS Score ≤ 12 at Week 6
Hide Description Number of subjects with MADRS total score ≤ 12 (indicates remission). MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts); rated on a 7-point Likert scale 0 (normal) to 6 (most abnormal); total score 0 to 44 (higher score indicates greater severity of symptoms).
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT; Last observation carried forward (LOCF)
Arm/Group Title Ziprasidone Placebo
Hide Arm/Group Description:
Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
Overall Number of Participants Analyzed 145 145
Measure Type: Number
Unit of Measure: participants
48 54
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ziprasidone, Placebo
Comments Week 6; LOCF; Logistic regression model with treatment, country, and type of mood stabilizer.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5029
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.846
Confidence Interval 95%
0.52 to 1.38
Estimation Comments Odds ratio measures the odds of achieving remission (MADRS total score ≤ 12) from ziprasidone treated subjects versus placebo; a value > 1 favors ziprasidone.
4.Secondary Outcome
Title MADRS Response: Number of Subjects With Total MADRS Score Reduction ≥ 50 Percent From Baseline at Week 6
Hide Description Number of subjects with reduction of ≥50 percent (%) in MADRS total score (indicates response). MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts); rated on a 7-point Likert scale 0 (normal) to 6 (most abnormal); total score 0 to 44 (higher score indicates greater severity of symptoms). Reduction calculated as ([A-B]/B*100): A=value at observation; B=baseline value.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT; LOCF
Arm/Group Title Ziprasidone Placebo
Hide Arm/Group Description:
Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
Overall Number of Participants Analyzed 145 145
Measure Type: Number
Unit of Measure: participants
62 65
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ziprasidone, Placebo
Comments Week 6; LOCF; Logistic regression model with treatment, country, and type of mood stabilizer.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8266
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.949
Confidence Interval 95%
0.59 to 1.52
Estimation Comments Odds ratio measures the odds of achieving response (≥ 50 % reduction in MADRS total score) from ziprasidone treated subjects versus placebo; a value > 1 favors ziprasidone.
5.Secondary Outcome
Title Clinical Global Impression - Improvement Scale (CGI-Improvement or CGI-I): Number of Subjects With Response (Much Improved or Very Much Improved) at Week 6
Hide Description Number of subjects with improvement defined as CGI-I response of 1 (very much improved) or 2 (much improved). CGI-I is a single-item clinician rated scale used to assess global improvement in the subject's clinical state (bipolar mania) in response to study treatment and as compared to their status at pre-treatment baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse). Higher score = more affected.
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT; LOCF
Arm/Group Title Ziprasidone Placebo
Hide Arm/Group Description:
Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
Overall Number of Participants Analyzed 145 145
Measure Type: Number
Unit of Measure: participants
66 69
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ziprasidone, Placebo
Comments Week 6; LOCF; Logistic regression model with treatment, country, and type of mood stabilizer.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7924
Comments Logistic regression model with treatment, country, and type of mood stabilizer.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.939
Confidence Interval 95%
0.59 to 1.50
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in MADRS Total Score (Post-baseline Excluding Week 6)
Hide Description MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts); rated on a 7-point Likert scale 0 (normal) to 6 (most abnormal); total score 0 to 44 (higher score indicates greater severity of symptoms). Change calculated as a difference between post-baseline observation and baseline MADRS score values.
Time Frame Baseline, Week 1, Week 2, Week 3, Week 4, Week 5
Hide Outcome Measure Data
Hide Analysis Population Description
ITT; LOCF; (n)=number of subjects with analyzable data: baseline and post-baseline observation for ziprasidone, placebo, respectively.
Arm/Group Title Ziprasidone Placebo
Hide Arm/Group Description:
Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
Overall Number of Participants Analyzed 145 145
Mean (Standard Deviation)
Unit of Measure: scores on scale
Week 1 (n=142, 141) -8.1  (7.9) -6.1  (7.3)
Week 2 (n=121, 139) -11.7  (8.9) -9.0  (8.6)
Week 3 (n=115, 130) -13.0  (9.5) -11.0  (9.2)
Week 4 (n=106, 122) -14.1  (9.6) -11.8  (9.5)
Week 5 (n=103, 112) -14.9  (9.4) -13.3  (10.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ziprasidone, Placebo
Comments Week 1; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0594
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean
Estimated Value -1.68
Confidence Interval 95%
-3.42 to 0.07
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.89
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ziprasidone, Placebo
Comments Week 2; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2230
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean
Estimated Value -1.25
Confidence Interval 95%
-3.27 to 0.77
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.03
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ziprasidone, Placebo
Comments Week 3; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6971
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean
Estimated Value -0.43
Confidence Interval 95%
-2.57 to 1.72
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.09
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Ziprasidone, Placebo
Comments Week 4; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5485
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean
Estimated Value -0.68
Confidence Interval 95%
-2.89 to 1.54
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.12
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Ziprasidone, Placebo
Comments Week 5; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8322
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean
Estimated Value -0.25
Confidence Interval 95%
-2.60 to 2.10
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.19
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in CGI-Severity Score (Post-baseline Excluding Week 6)
Hide Description CGI-S is a single-item clinician rated scale used to assess global severity of bipolar illness based on an overall evaluation of symptoms of bipolar mania, associated behavioral symptoms, and condition of the subject. Scores range from 1 (normal, not at all ill) to 7 (among the most severely ill subjects). Higher score = more affected. Change calculated as a difference between post-baseline observation and baseline CGI-S score values.
Time Frame Baseline, Week 1, Week 2, Week 3, Week 4, Week 5
Hide Outcome Measure Data
Hide Analysis Population Description
ITT; LOCF; (n)=number of subjects with analyzable data: baseline and post-baseline observation for ziprasidone, placebo, respectively.
Arm/Group Title Ziprasidone Placebo
Hide Arm/Group Description:
Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
Overall Number of Participants Analyzed 145 145
Mean (Standard Deviation)
Unit of Measure: scores on scale
Week 1 (n=142, 141) -0.5  (0.8) -0.4  (0.8)
Week 2 (n=120, 139) -0.9  (1.1) -0.7  (0.9)
Week 3 (n=115, 130) -0.9  (1.0) -0.9  (1.0)
Week 4 (n=106, 122) -1.1  (1.1) -1.1  (1.1)
Week 5 (n=103, 112) -1.3  (1.2) -1.3  (1.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ziprasidone, Placebo
Comments Week 1; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1771
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean
Estimated Value -0.12
Confidence Interval 95%
-0.29 to 0.05
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.09
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ziprasidone, Placebo
Comments Week 2; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1765
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean
Estimated Value -0.15
Confidence Interval 95%
-0.37 to 0.07
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.11
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ziprasidone, Placebo
Comments Week 3; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6765
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean
Estimated Value -0.05
Confidence Interval 95%
-0.27 to 0.18
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.11
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Ziprasidone, Placebo
Comments Week 4; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9770
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean
Estimated Value 0.00
Confidence Interval 95%
-0.24 to 0.25
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.12
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Ziprasidone, Placebo
Comments Week 5; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7907
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean
Estimated Value -0.04
Confidence Interval 95%
-0.30 to 0.23
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.13
Estimation Comments [Not Specified]
8.Secondary Outcome
Title CGI-Improvement Score
Hide Description CGI-I is a single-item clinician rated scale used to assess global improvement in the subject's clinical state (bipolar mania) in response to study treatment and as compared to their status at pre-treatment baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse). Higher score = more affected. Week 6 is the primary timepoint.
Time Frame Week 1, Week 2, Week 3, Week 4, Week 5, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT; LOCF; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively.
Arm/Group Title Ziprasidone Placebo
Hide Arm/Group Description:
Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
Overall Number of Participants Analyzed 145 145
Mean (Standard Deviation)
Unit of Measure: scores on scale
Week 1 (n=142, 141) 3.2  (0.9) 3.4  (0.8)
Week 2 (n=120, 138) 2.9  (1.1) 3.1  (1.0)
Week 3 (n=115, 130) 2.7  (1.0) 2.9  (1.0)
Week 4 (n=106, 122) 2.6  (1.2) 2.8  (1.2)
Week 5 (n=103, 112) 2.5  (1.2) 2.6  (1.1)
Week 6 (n=92, 108) 2.4  (1.2) 2.4  (1.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ziprasidone, Placebo
Comments Week 1; LOCF; Analysis of variance model with treatment, country, type of mood stabilizer as fixed effects.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0392
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean
Estimated Value -0.22
Confidence Interval 95%
-0.43 to -0.01
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.11
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ziprasidone, Placebo
Comments Week 2; LOCF; Analysis of variance model with treatment, country, type of mood stabilizer as fixed effects.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2803
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean
Estimated Value -0.14
Confidence Interval 95%
-0.38 to 0.11
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.13
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ziprasidone, Placebo
Comments Week 3; LOCF; Analysis of variance model with treatment, country, type of mood stabilizer as fixed effects.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9835
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean
Estimated Value -0.00
Confidence Interval 95%
-0.26 to 0.26
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.13
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Ziprasidone, Placebo
Comments Week 4; LOCF; Analysis of variance model with treatment, country, type of mood stabilizer as fixed effects.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7062
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean
Estimated Value -0.06
Confidence Interval 95%
-0.34 to 0.23
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.15
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Ziprasidone, Placebo
Comments Week 5; LOCF; Analysis of variance model with treatment, country, type of mood stabilizer as fixed effects.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9518
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean
Estimated Value -0.01
Confidence Interval 95%
-0.31 to 0.29
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.15
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Ziprasidone, Placebo
Comments Week 6; LOCF
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4757
Comments Analysis of variance model with treatment, country, type of mood stabilizer as fixed effects.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean
Estimated Value 0.11
Confidence Interval 95%
-0.20 to 0.42
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.16
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score
Hide Description HAM-A is a clinician rated 14-item scale that rates the intensity of psychic anxiety (items 1 to 6 and item 14) and somatic anxiety (items 7 to 13) on a 5-point severity scale; scores range from 0 (not present) to 4 (very severe); lower score indicates less affected. Change calculated as a difference between post-baseline observation and baseline HAM-A score values. Week 6 is the primary timepoint.
Time Frame Baseline, Week 2, Week 4, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT; LOCF; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively.
Arm/Group Title Ziprasidone Placebo
Hide Arm/Group Description:
Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
Overall Number of Participants Analyzed 145 145
Mean (Standard Deviation)
Unit of Measure: scores on scale
Week 2 (n=136, 141) -5.6  (6.8) -5.9  (6.7)
Week 4 (n=111, 127) -7.1  (7.2) -7.4  (7.6)
Week 6 (n=100, 111) -8.5  (7.9) -8.6  (7.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ziprasidone, Placebo
Comments Week 2; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6362
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean
Estimated Value 0.35
Confidence Interval 95%
-1.12 to 1.82
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.75
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ziprasidone, Placebo
Comments Week 4; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4565
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean
Estimated Value 0.59
Confidence Interval 95%
-0.98 to 2.17
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.80
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ziprasidone, Placebo
Comments Week 6; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4770
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean
Estimated Value 0.61
Confidence Interval 95%
-1.08 to 2.30
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.86
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline in Young Mania Rating Scale (YMRS) Total Score
Hide Description YMRS is clinician rated 11-item scale (elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, speech [rate and amount], language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight) used to assess the severity of manic symptoms and effect of treatment on mania severity. Seven items ranked on scale from 0 to 4; 4 items ranked 0 to 8. Higher scores indicate greater severity. Change calculated as a difference between post-baseline observation and baseline YMRS score values. Week 6 is the primary timepoint.
Time Frame Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT; LOCF; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively.
Arm/Group Title Ziprasidone Placebo
Hide Arm/Group Description:
Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
Overall Number of Participants Analyzed 145 145
Mean (Standard Deviation)
Unit of Measure: scores on scale
Week 1 (n=142, 141) 0.7  (4.4) -0.2  (3.5)
Week 2 (n=121, 139) 0.5  (4.5) -0.2  (4.3)
Week 3 (n=115, 130) -0.0  (4.5) -0.2  (4.9)
Week 4 (n=106, 122) -0.9  (4.1) -1.1  (4.2)
Week 5 (n=103, 112) -0.9  (3.9) -1.3  (4.1)
Week 6 (n=92, 108) -1.0  (4.8) -0.9  (4.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ziprasidone, Placebo
Comments Week 1; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1277
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean
Estimated Value 0.70
Confidence Interval 95%
-0.20 to 1.60
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.46
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ziprasidone, Placebo
Comments Week 2; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2345
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean
Estimated Value 0.64
Confidence Interval 95%
-0.41 to 1.68
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.53
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ziprasidone, Placebo
Comments Week 3; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8337
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean
Estimated Value 0.13
Confidence Interval 95%
-1.05 to 1.30
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.60
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Ziprasidone, Placebo
Comments Week 4; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4646
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean
Estimated Value 0.43
Confidence Interval 95%
-0.73 to 1.59
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.59
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Ziprasidone, Placebo
Comments Week 5; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3993
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean
Estimated Value 0.50
Confidence Interval 95%
-0.67 to 1.67
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.59
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Ziprasidone, Placebo
Comments Week 6; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7647
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean
Estimated Value 0.19
Confidence Interval 95%
-1.08 to 1.46
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.65
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline in Global Assessment of Functioning (GAF) Scale at Week 6
Hide Description GAF is a clinician rated scale to measure the severity of illness-related impairment in psychological, social, and occupational functioning using a 100-point scale (single score of 1 to 100) with 100 indicating a superior level of function. Change calculated as a difference between post-baseline observation and baseline GAF score values.
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT; observed cases; Early Termination (ET) visits re-slotted to regular weekly visits according to duration since first dosing date; ET Visit only includes observations from visits that did not meet windowing criteria; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively.
Arm/Group Title Ziprasidone Placebo
Hide Arm/Group Description:
Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
Overall Number of Participants Analyzed 145 145
Mean (Standard Deviation)
Unit of Measure: scores on scale
Week 6 (n=100, 110) 14.7  (13.8) 11.2  (12.3)
ET (n=34, 27) 0.0  (7.1) 2.8  (9.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ziprasidone, Placebo
Comments Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0108
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean
Estimated Value 4.24
Confidence Interval 95%
0.99 to 7.50
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.65
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Change From Baseline in Sheehan Disability Scale (SDS) at Week 6 (Items 1 Through 3)
Hide Description SDS is a 5-item subject rated scale to measure the extent to which work and or school, social life and or leisure activities, and home life and or family responsibilities were impaired by psychiatric illness. Items 1 to 3 rated on 11-point scale ranging 0 (not at all) to 10 (extremely affected). Total score 0 to 30; higher score indicates greater impairment; items 4 and 5 report number of days in the last month (0 to 31) subject missed work or school or was unproductive and are rated separately. Change calculated as a difference between post-baseline observation and baseline SDS score values.
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT; ET visits re-slotted to regular weekly visits according to duration since first dosing date; ET Visit only includes observations from visits that did not meet windowing criteria; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively.
Arm/Group Title Ziprasidone Placebo
Hide Arm/Group Description:
Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
Overall Number of Participants Analyzed 145 145
Mean (Standard Deviation)
Unit of Measure: scores on scale
Total SDS: Week 6 (n=58, 63) -8.5  (9.2) -3.7  (8.2)
Total SDS: ET (n=19, 14) 0.2  (6.8) -1.4  (6.7)
Work/School: Week 6 (n=58, 64) -2.1  (3.5) -1.6  (2.9)
Work/School: ET (n=19, 14) 0.4  (3.0) -0.1  (2.7)
Social life: Week 6 (n=94, 102) -2.5  (3.3) -1.7  (3.2)
Social life: ET (n=31, 23) -0.5  (2.9) 0.1  (3.1)
Family/Home: Week 6 (n=94, 102) -2.6  (3.2) -1.7  (3.3)
Family/Home: ET (n=31, 23) 0.2  (2.3) -0.6  (3.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ziprasidone, Placebo
Comments Total SDS: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0010
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean
Estimated Value -4.56
Confidence Interval 95%
-7.24 to -1.87
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.35
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Change From Baseline in Sheehan Disability Scale (SDS) at Week 6 (Items 4 and 5)
Hide Description SDS is a 5-item subject rated scale to measure the extent to which work and or school, social life and or leisure activities, and home life and or family responsibilities were impaired by psychiatric illness. Items 1 to 3 rated on 11-point scale ranging 0 (not at all) to 10 (extremely affected). Total score 0 to 30; higher score indicates greater impairment; items 4 and 5 report number of days in the last month (0 to 31) subject missed work or school or was unproductive and are rated separately. Change calculated as a difference between post-baseline observation and baseline SDS score values.
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT; ET visits re-slotted to regular weekly visits according to duration since first dosing date; ET Visit only includes observations from visits that did not meet windowing criteria; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively.
Arm/Group Title Ziprasidone Placebo
Hide Arm/Group Description:
Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
Overall Number of Participants Analyzed 145 145
Mean (Standard Deviation)
Unit of Measure: days
Days lost: Week 6 (n=85, 93) -1.2  (2.5) -0.7  (2.3)
Days lost: ET (n=29, 21) 0.5  (2.7) 0.0  (2.2)
Days unproductive: Week 6 (n=87, 89) -1.6  (2.8) -1.3  (2.9)
Days unproductive: ET (n=29, 21) -0.2  (2.5) -0.1  (3.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ziprasidone, Placebo
Comments Days Lost: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1230
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean
Estimated Value -0.44
Confidence Interval (2-Sided) 95%
-1.00 to 0.12
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.28
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ziprasidone, Placebo
Comments Days Unproductive: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6232
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean
Estimated Value -0.17
Confidence Interval (2-Sided) 95%
-0.84 to 0.50
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.34
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Change From Baseline in Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q) Scores at Week 6
Hide Description Q-LES-Q is a 16-item subject rated scale to measure satisfaction with areas of daily functioning (physical health, social relationships, medication, and overall life satisfaction); rated on a 5-point Likert scale: higher scores indicate greater enjoyment and satisfaction with general life activities. Scores for items 1 to 14 are summed for a total score and converted to 0 to 100 range. Items 15 and 16 measure satisfaction with medication and overall satisfaction and are analyzed separately. Change calculated as a difference between post-baseline observation and baseline Q-LES-Q score values.
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT; ET visits re-slotted to regular weekly visits according to duration since first dosing date; ET Visit only includes observations from visits that did not meet windowing criteria; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively.
Arm/Group Title Ziprasidone Placebo
Hide Arm/Group Description:
Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
Overall Number of Participants Analyzed 145 145
Mean (Standard Deviation)
Unit of Measure: scores on scale
Total Q-LES-Q: Week 6 (n=82, 94) 15.2  (19.0) 11.6  (17.3)
Total Q-LES-Q: ET (n=27, 17) -0.1  (19.7) 1.6  (14.5)
Medications: Week 6 (n=91, 93) 0.4  (1.2) 0.3  (1.1)
Medications: ET (n=27, 20) -0.3  (1.2) -0.4  (0.8)
Overall life satisfaction: Week 6 (n=94, 103) 0.8  (1.1) 0.5  (1.1)
Overall life satisfaction: ET (n=31, 23) 0.1  (1.3) 0.0  (0.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ziprasidone, Placebo
Comments Total Q-LES-Q: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5519
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean
Estimated Value 1.52
Confidence Interval 95%
-3.50 to 6.53
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.54
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ziprasidone, Placebo
Comments Medications: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5238
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean
Estimated Value -0.09
Confidence Interval 95%
-0.35 to 0.18
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.13
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ziprasidone, Placebo
Comments Overall life satisfaction: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5360
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean
Estimated Value 0.09
Confidence Interval 95%
-0.19 to 0.36
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14
Estimation Comments [Not Specified]
15.Other Pre-specified Outcome
Title Change From Baseline in Simpson Angus Scale (SAS) Score
Hide Description SAS is a clinician rated 10-item scale to measure extrapyramidal side effects (Parkinsonism or Parkinsonian side effects induced with antipsychotics); rated on a 5-point scale with range 0 (absence of condition) to 4 (presence of condition in extreme form). Global score is sum of all scores divided by the total number of items. Change calculated as a difference between post-baseline observation and baseline SAS score values.
Time Frame Baseline, Week 2, Week 4, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively.
Arm/Group Title Ziprasidone Placebo
Hide Arm/Group Description:
Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
Overall Number of Participants Analyzed 145 145
Mean (Standard Deviation)
Unit of Measure: scores on scale
Week 2 (n=136, 141) 0.1  (0.8) -0.1  (0.7)
Week 4 (n=111, 126) 0.0  (0.8) 0.0  (0.6)
Week 6 (n=100, 110) 0.0  (0.7) -0.1  (0.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ziprasidone, Placebo
Comments Week 2; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0096
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean
Estimated Value 0.17
Confidence Interval 95%
0.04 to 0.31
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.07
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ziprasidone, Placebo
Comments Week 4; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8134
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean
Estimated Value 0.02
Confidence Interval 95%
-0.13 to 0.16
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.07
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ziprasidone, Placebo
Comments Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0226
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean
Estimated Value 0.16
Confidence Interval 95%
0.02 to 0.29
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.07
Estimation Comments [Not Specified]
16.Other Pre-specified Outcome
Title Change From Baseline in Barnes Akathisia Rating Scale (BARS or BAS)
Hide Description BARS is a clinician rated scale to evaluate akathisia associated with use of antipsychotic medications: objective motor restlessness, range 0 to 3; subjective complaints of restlessness and associated distress, range 0 to 3; global clinical assessment of akathisia, range 0 to 5. Higher scores indicate more affected. Change calculated as a difference between post-baseline observation and baseline BARS score values.
Time Frame Baseline, Week 2, Week 4, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT; Summarized as Global BARS; individual scores not summarized; (n)=number of subjects with analyzable data at observation for ziprasidone and placebo, respectively.
Arm/Group Title Ziprasidone Placebo
Hide Arm/Group Description:
Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
Overall Number of Participants Analyzed 145 145
Mean (Standard Deviation)
Unit of Measure: scores on scale
Week 2 (n=135, 139) 0.1  (0.5) -0.0  (0.4)
Week 4 (n=111, 125) 0.0  (0.5) 0.0  (0.5)
Week 6 (n=100, 110) 0.0  (0.6) -0.0  (0.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ziprasidone, Placebo
Comments Week 2; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0193
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean
Estimated Value 0.12
Confidence Interval 95%
0.02 to 0.23
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.05
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ziprasidone, Placebo
Comments Week 4; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4745
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean
Estimated Value 0.04
Confidence Interval 0.16%
-0.07 to 0.16
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.06
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ziprasidone, Placebo
Comments Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2613
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean
Estimated Value 0.07
Confidence Interval 95%
-0.05 to 0.19
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.06
Estimation Comments [Not Specified]
17.Other Pre-specified Outcome
Title Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Scores
Hide Description AIMS is a clinician rated 12-item scale to rate 7 body areas and global judgments on the severity of abnormal movements, incapacitation and subject's awareness of abnormal movements. Items 1 to 10 scored 0 (none) to 4 (severe); items 11 to 14 are No or Yes response to dental status and sleep movements and are assessed separately. AIMS total score is sum of first 7 items. Change calculated as a difference between post-baseline observation and baseline AIMS score values.
Time Frame Baseline, Week 2, Week 4, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively.
Arm/Group Title Ziprasidone Placebo
Hide Arm/Group Description:
Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
Overall Number of Participants Analyzed 145 145
Mean (Standard Deviation)
Unit of Measure: scores on scale
Total score: Week 2 (n=136, 142) 0.1  (0.7) -0.1  (0.4)
Total score: Week 4 (n=111, 127) -0.0  (0.5) -0.0  (0.5)
Total score: Week 6 (n=100, 111) -0.0  (0.6) -0.0  (0.4)
Global severity score: Week 2 (n=136, 142) 0.0  (0.4) -0.0  (0.2)
Global severity score: Week 4 (n=111, 127) 0.0  (0.3) 0.0  (0.2)
Global severity score: Week 6 (n=100, 111) 0.0  (0.3) 0.0  (0.1)
Incapacitation score: Week 2 (n=136, 142) 0.0  (0.2) -0.0  (0.1)
Incapacitation score: Week 4 (n=111, 127) 0.0  (0.1) -0.0  (0.2)
Incapacitation score: Week 6 (n=100, 111) 0.0  (0.1) 0.0  (0.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ziprasidone, Placebo
Comments Total score: Week 2; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0271
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean
Estimated Value 0.11
Confidence Interval 95%
0.01 to 0.21
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.05
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ziprasidone, Placebo
Comments Total score: Week 4; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7462
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean
Estimated Value -0.01
Confidence Interval 95%
-0.07 to 0.05
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.03
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ziprasidone, Placebo
Comments Total score: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9574
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean
Estimated Value 0.00
Confidence Interval 95%
-0.08 to 0.08
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.04
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Ziprasidone, Placebo
Comments Global severity score: Week 2; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0844
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean
Estimated Value 0.05
Confidence Interval 95%
-0.01 to 0.10
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.03
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Ziprasidone, Placebo
Comments Global severity score: Week 4; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5779
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean
Estimated Value 0.01
Confidence Interval 95%
-0.04 to 0.06
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.02
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Ziprasidone, Placebo
Comments Global severity score: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7455
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean
Estimated Value 0.01
Confidence Interval 95%
-0.05 to 0.06
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.03
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Ziprasidone, Placebo
Comments Incapacitation score: Week 2; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3278
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean
Estimated Value 0.02
Confidence Interval 95%
-0.02 to 0.05
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.02
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Ziprasidone, Placebo
Comments Incapacitation score: Week 4; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9097
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean
Estimated Value 0.00
Confidence Interval 95%
-0.03 to 0.03
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.01
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Ziprasidone, Placebo
Comments Incapacitation score: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9864
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean
Estimated Value 0.00
Confidence Interval 95%
-0.04 to 0.04
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.02
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ziprasidone Placebo
Hide Arm/Group Description Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine). Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
All-Cause Mortality
Ziprasidone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ziprasidone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1/147 (0.68%)   6/147 (4.08%) 
Cardiac disorders     
Palpitations  1  0/147 (0.00%)  1/147 (0.68%) 
Injury, poisoning and procedural complications     
Overdose  1  1/147 (0.68%)  0/147 (0.00%) 
Psychiatric disorders     
Bipolar I disorder  1  0/147 (0.00%)  1/147 (0.68%) 
Intentional self-injury  1  0/147 (0.00%)  1/147 (0.68%) 
Mania  1  0/147 (0.00%)  2/147 (1.36%) 
Suicidal ideation  1  0/147 (0.00%)  1/147 (0.68%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  1/147 (0.68%)  0/147 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ziprasidone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   96/147 (65.31%)   57/147 (38.78%) 
Gastrointestinal disorders     
Diarrhoea  1  7/147 (4.76%)  11/147 (7.48%) 
Nausea  1  16/147 (10.88%)  8/147 (5.44%) 
General disorders     
Fatigue  1  19/147 (12.93%)  6/147 (4.08%) 
Nervous system disorders     
Akathisia  1  8/147 (5.44%)  2/147 (1.36%) 
Dizziness  1  19/147 (12.93%)  9/147 (6.12%) 
Headache  1  17/147 (11.56%)  14/147 (9.52%) 
Sedation  1  21/147 (14.29%)  7/147 (4.76%) 
Somnolence  1  33/147 (22.45%)  7/147 (4.76%) 
Tremor  1  13/147 (8.84%)  10/147 (6.80%) 
Psychiatric disorders     
Anxiety  1  9/147 (6.12%)  1/147 (0.68%) 
Insomnia  1  17/147 (11.56%)  10/147 (6.80%) 
Restlessness  1  8/147 (5.44%)  2/147 (1.36%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
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 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information 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: NCT00483548     History of Changes
Other Study ID Numbers: A1281158
First Submitted: June 5, 2007
First Posted: June 7, 2007
Results First Submitted: December 22, 2009
Results First Posted: February 23, 2010
Last Update Posted: February 23, 2010