A Six-Week Study Evaluating The Efficacy And Safety Of Geodon In Patients With A Diagnosis Of Bipolar I Depression

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00141271
First received: August 30, 2005
Last updated: April 3, 2009
Last verified: April 2009
Results First Received: February 24, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Bipolar Disorder
Interventions: Drug: Geodon (Ziprasidone)
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
56 centers in the US

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
7-day washout:psychotropic drugs & lithium. 4-week washout: monoamine oxidase inhibitors, fluoxetine alone or in combination with olanzapine. Depot neuroleptic Discontinued (DC'd) 6 mo prior to entry. 536 subjects enrolled: 504 assigned to drug; 32 not assigned:18 lost to follow up, 5 DC'd study, 9 didn't take/receive study drug for other reasons.

Reporting Groups
  Description
120-160mg Ziprasidone Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
40-80 mg Ziprasidone Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
Placebo Subjects were assigned to placebo

Participant Flow:   Overall Study
    120-160mg Ziprasidone     40-80 mg Ziprasidone     Placebo  
STARTED     171     165     168  
COMPLETED     91     102     111  
NOT COMPLETED     80     63     57  
Adverse Event                 31                 19                 17  
Laboratory Abnormality                 2                 1                 1  
Lack of Efficacy                 7                 7                 3  
Lost to Follow-up                 15                 15                 21  
Withdrawal by Subject                 14                 9                 10  
Unknown                 11                 12                 5  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
120-160mg Ziprasidone Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
40-80 mg Ziprasidone Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
Placebo Subjects were assigned to placebo
Total Total of all reporting groups

Baseline Measures
    120-160mg Ziprasidone     40-80 mg Ziprasidone     Placebo     Total  
Number of Participants  
[units: participants]
  171     165     168     504  
Age  
[units: years]
Mean ± Standard Deviation
  40.4  ± 12.9     40.0  ± 11.4     39.3  ± 11.2     39.9  ± 11.8  
Gender  
[units: participants]
       
Female     91     101     92     284  
Male     80     64     76     220  



  Outcome Measures
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1.  Primary:   Change in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score   [ Time Frame: Baseline to 6 weeks ]

2.  Secondary:   Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score   [ Time Frame: Baseline to 6 weeks ]

3.  Secondary:   Response Greater Than or Equal to 50 Percent Decrease From Baseline in Hamilton Depression Rating Scale (HAM-D 17) Total Score   [ Time Frame: Baseline to 6 weeks ]

4.  Secondary:   Change in Global Assessment of Functioning (GAF)at Endpoint, Last Observation Carried Forward (LOCF)   [ Time Frame: Baseline, 6 Weeks LOCF ]

5.  Secondary:   Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12   [ Time Frame: Baseline to 6 weeks ]

6.  Secondary:   Remission as Measured by Hamilton Depression (HAM-D 17) Total Score Less Than or Equal to 7   [ Time Frame: Baseline to 6 weeks ]

7.  Secondary:   Change in Hamilton Depression (HAM-D 17) Total Score   [ Time Frame: Baseline to 6 weeks ]

8.  Secondary:   Change in Hamilton Anxiety Rating (HAM-A)   [ Time Frame: Baseline to 6 weeks ]

9.  Secondary:   Change in Total Score of Young Mania Rating Scale (YMRS)   [ Time Frame: Baseline to 6 weeks ]

10.  Secondary:   Change in Assessment of Global Clinical Severity of Symptoms (CGI-S)   [ Time Frame: Baseline to 6 weeks ]

11.  Secondary:   Change in Global Clinical Improvement of Symptoms (CGI -I)   [ Time Frame: Baseline to 6 weeks ]

12.  Secondary:   Change in Total Score in Hamilton Depression (HAM-D 25)   [ Time Frame: Baseline to 6 Weeks ]

13.  Secondary:   Response as Measured by CGI-I Score Less Than or Equal to 2   [ Time Frame: Week 1 through Week 6 (endpoint) ]

14.  Secondary:   Change in Sheehan Disability Scale (SDS) Total Score at Endpoint   [ Time Frame: Baseline to Week 6 ]

15.  Secondary:   Change in Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q) Total Score at Endpoint   [ Time Frame: Baseline to 6 Weeks ]

16.  Secondary:   Change in Bech Melancholia Score   [ Time Frame: Baseline to 6 Weeks ]

17.  Secondary:   Change in Anxiety/Somatizations Factor Total Score   [ Time Frame: Baseline to 6 Weeks ]

18.  Secondary:   Change in Retardation Factor Scores   [ Time Frame: Baseline to 6 Weeks ]

19.  Secondary:   Change in Sleep Disturbance Factor Score   [ Time Frame: Baseline to 6 weeks ]

20.  Secondary:   Change in Verbal Memory Trial Performance Total Score at Endpoint   [ Time Frame: Baseline to 6 Weeks LOCF ]

21.  Secondary:   Change in Affective Interference Test Immediate Recall List 1 Emotional Words at Endpoint   [ Time Frame: Baseline to 6 Weeks LOCF ]

22.  Secondary:   Change in Affective Interference Test Immediate Recall Non-Emotional Words List 1 at Endpoint   [ Time Frame: Baseline to 6 Weeks LOCF ]

23.  Secondary:   Change in Affective Interference Test, Immediate Recall, List 2 Emotional Words at Endpoint   [ Time Frame: Baseline to 6 Weeks LOCF ]

24.  Secondary:   Change in Affective Interference Test, Immediate Recall, List 2 Non-Emotional Words at Endpoint   [ Time Frame: Baseline to 6 Weeks LOCF ]

25.  Secondary:   Change in Affective Interference Test, Immediate Recall, List 3 Emotional Words at Endpoint   [ Time Frame: Baseline to Week 6 LOCF ]

26.  Secondary:   Change in Affective Interference Test, Immediate Recall, List 3 Non-Emotional Words at Endpoint   [ Time Frame: Baseline to Week 6 LOCF ]

27.  Secondary:   Change in Affective Interference Test, Immediate Recall, Cued-Recall Non-Emotional Words at Endpoint   [ Time Frame: Baseline to 6 Weeks LOCF ]

28.  Secondary:   Change in Affective Interference Test, Immediate Recall, Cued-Recall Emotional Words at Endpoint   [ Time Frame: Baseline to 6 Weeks LOCF ]

29.  Secondary:   Change in Digit Sequencing Task at Endpoint   [ Time Frame: Baseline to 6 Weeks LOCF ]

30.  Secondary:   Change in Token Motor Task at Endpoint   [ Time Frame: Baseline to 6 Weeks LOCF ]

31.  Secondary:   Change in Verbal Fluency in Naming Categories at Endpoint   [ Time Frame: Baseline to 6 Weeks LOCF ]

32.  Secondary:   Change in Verbal Fluency Controlled Word Association at Endpoint   [ Time Frame: Baseline to 6 Weeks LOCF ]

33.  Secondary:   Change in Symbol Coding at Endpoint   [ Time Frame: Baseline to 6 Weeks LOCF ]

34.  Secondary:   Change in Tower of London Test at Endpoint   [ Time Frame: Baseline to 6 Weeks LOCF ]

35.  Secondary:   Change in Affective Interference Test, Delayed Recognition, Emotional Words at Endpoint   [ Time Frame: Baseline to 6 Weeks LOCF ]

36.  Secondary:   Change in Affective Interference Test, Delayed Recognition, Emotional Words False Alarms at Endpoint   [ Time Frame: Baseline to 6 Weeks LOCF ]

37.  Secondary:   Change in Affective Interference Test, Delayed Recognition, Non-Emotional Words at Endpoint   [ Time Frame: Baseline to Week 6 LOCF ]

38.  Secondary:   Change in Affective Interference Test, Delayed Recognition, Non-Emotional Words False Alarms at Endpoint   [ Time Frame: Baseline to Week 6 LOCF ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.govCallCenter@pfizer.com


No publications provided by Pfizer

Publications automatically indexed to this study:

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00141271     History of Changes
Other Study ID Numbers: A1281136
Study First Received: August 30, 2005
Results First Received: February 24, 2009
Last Updated: April 3, 2009
Health Authority: United States: Food and Drug Administration