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Safety Study of Ziprasidone (Geodon) for the Depressive Mixed State

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Tufts Medical Center
ClinicalTrials.gov Identifier:
NCT00490542
First received: June 20, 2007
Last updated: July 12, 2016
Last verified: July 2016
Results First Received: August 3, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Bipolar Disorder
Bipolar Depression
Depression
Interventions: Drug: ziprasidone (Geodon)
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Double-blind Flexible-dose Placebo Arm Participants in this arm received placebo and were instructed to take it daily for 6 weeks. Participants did not know whether they were taking placebo or ziprasidone (Geodon). Dosing was flexible. Dosing for all subjects was determined based on clinician judgment in an identical manner to dosing in the ziprasidone arm.
Double-blind Flexible-dose Ziprasidone Arm Participants in this arm received a flexible dose of ziprasidone and were instructed to take it daily for 6 weeks. Participants did not know whether they were taking placebo or ziprasidone (Geodon). Dosing for all subjects began at 20 mg twice a day and increased to between 80 and 160 mg/day total.

Participant Flow:   Overall Study
    Double-blind Flexible-dose Placebo Arm   Double-blind Flexible-dose Ziprasidone Arm
STARTED   38   35 
COMPLETED   31   31 
NOT COMPLETED   7   4 
Lost to Follow-up                3                0 
Adverse Event                3                3 
Lack of Efficacy                1                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
Placebo Arm Participants in this arm received placebo and were instructed to take it daily for 6 weeks. Participants did not know whether they were taking placebo or ziprasidone (Geodon).
Geodon Arm Participants in this arm received Geodon and were instructed to take it daily for 6 weeks. Participants did not know whether they were taking placebo or ziprasidone (Geodon).
Total Total of all reporting groups

Baseline Measures
   Placebo Arm   Geodon Arm   Total 
Overall Participants Analyzed 
[Units: Participants]
 38   35   73 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   38   35   73 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 38.6  (12.7)   39.1  (11.9)   38.7  (12.2) 
Gender 
[Units: Participants]
     
Female   20   18   38 
Male   18   17   35 
Region of Enrollment 
[Units: Participants]
     
United States   38   35   73 


  Outcome Measures

1.  Primary:   The Primary Outcome Measure Was Change in Montgomery-Asberg Depression Rating Scale (MADRS) Scores Over Weeks Between Groups.   [ Time Frame: Baseline to 6 weeks ]


  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
One potential limitation in relation to secondary analyses would be sample size. The randomized study design should account for most potential confounding effects, but residual confounding cannot be completely eliminated without larger studies.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: S. Nassir Ghaemi, MD, MPH
Organization: Tufts Medical Center
phone: 617-636-5735
e-mail: nghaemi@tuftsmedicalcenter.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT00490542     History of Changes
Other Study ID Numbers: GA128000
Study First Received: June 20, 2007
Results First Received: August 3, 2011
Last Updated: July 12, 2016
Health Authority: United States: Institutional Review Board