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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00282464
First received: January 24, 2006
Last updated: June 1, 2009
Last verified: June 2009
Results First Received: March 3, 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: Placebo
Drug: Geodon (Ziprasidone)

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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

Reporting Groups
  Description
Ziprasidone 20-80mg Bid 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).
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Participant Flow:   Overall Study
    Ziprasidone 20-80mg Bid     Placebo  
STARTED     185     196  
COMPLETED     112     134  
NOT COMPLETED     73     62  
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  



  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
Ziprasidone 20-80mg Bid 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).
Placebo No text entered.
Total Total of all reporting groups

Baseline Measures
    Ziprasidone 20-80mg Bid     Placebo     Total  
Number of Participants  
[units: participants]
  185     196     381  
Age  
[units: years]
Mean ± Standard Deviation
  40.4  ± 12.5     40.0  ± 11.7     40.2  ± 12.1  
Gender  
[units: participants]
     
Female     108     111     219  
Male     77     85     162  



  Outcome Measures
  Show All Outcome Measures

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

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

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 Week 3, Week 6 ]

4.  Secondary:   Remission as Measured by Montgomery Asberg Depression Scale (MADRS) Total Score Less Than or Equal to 12   [ Time Frame: Week 1 to Week 6 ]

5.  Secondary:   Remission as Measured by Hamilton Asberg Depression Rating Scale (HAM-D 17) Total Score Less Than or Equal to 7   [ Time Frame: Week 3, Week 6 ]

6.  Secondary:   Change in Hamilton Depression Rating Scale (HAM-D 17) Total Score   [ Time Frame: Baseline to Weeks 3, 6 ]

7.  Secondary:   Change in Total Score in Hamiliton Depression Rating Scale (HAM-D 25)   [ Time Frame: Baseline to Weeks 3, 6 ]

8.  Secondary:   Change in Bech Melancholia Score   [ Time Frame: Baseline to Weeks 3, 6 ]

9.  Secondary:   Change in Anxiety/Somatizations Factor Total Score   [ Time Frame: Baseline to Weeks 3, 6 ]

10.  Secondary:   Change in Retardation Factor Scores   [ Time Frame: Baseline to Weeks 3, 6 ]

11.  Secondary:   Change in Sleep Disturbance Factor Score   [ Time Frame: Baseline to Weeks 3, 6 ]

12.  Secondary:   Change in Hamilton Anxiety Rating (HAM-A)   [ Time Frame: Baseline to Weeks 3, 6 ]

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

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

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

16.  Secondary:   Change in Global Assessment of Functioning (GAF)   [ Time Frame: Baseline to week 6 (Endpoint) ]

17.  Secondary:   Change in Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q) Total Score   [ Time Frame: Baseline to week 6 (endpoint) ]

18.  Secondary:   Change in Sheehan Disability Scale (SDS) Total Score   [ Time Frame: Baseline to week 6 (endpoint) ]

19.  Secondary:   Change in Bipolar Cognition Rating Scale (BPCoRS) Interviewer Global Rating of Subject   [ Time Frame: Baseline to week 6 (endpoint) ]

20.  Secondary:   Change in Bipolar Cognition Rating Scale (BPCoRS) Informant Global Rating   [ Time Frame: Baseline to week 6 (endpoint) ]

21.  Secondary:   Change in Bipolar Cognition Rating Scale (BPCoRS) Global Rating by Interviewer   [ Time Frame: Baseline to week 6 (endpoint) ]

22.  Secondary:   Change in Bipolar Cognition Rating Scale (BPCoRS) Subject Rating at Endpoint   [ Time Frame: Baseline to Week 6 (endpoint) ]


  Serious Adverse Events


  Other Adverse Events


  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.


Limitations and Caveats
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
No text entered.  


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: NCT00282464     History of Changes
Other Study ID Numbers: A1281139
Study First Received: January 24, 2006
Results First Received: March 3, 2009
Last Updated: June 1, 2009
Health Authority: United States: Food and Drug Administration