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Open-Label Study of Geodon in Non-Rapid Cycling Bipolar II Patients With Major Depression

This study has been completed.
Liebowitz, Michael R., M.D.
Information provided by (Responsible Party):
The Medical Research Network Identifier:
First received: October 7, 2005
Last updated: May 9, 2013
Last verified: May 2013
Results First Received: November 20, 2012  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Bipolar II Disorder
Major Depressive Episode
Intervention: Drug: 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
The trial was conducted at three research centers, located in: New York, NY; Plano, TX; and Seattle, WA. Subjects were recruited over a 37 month period.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The planned and actual study population was 30 patients, 18 years of age or older, who met DSM-IV criteria for bipolar II disorder with a history of at least one hypomanic episode.

Reporting Groups
Ziprasidone Patients will receive 8 weeks of active treatment with ziprasidone, initiated at 20mg BID. Depending on tolerability and clinical response, the dosage can be titrated up to a maximum of 60mg BID per day. Dosage can be lowered or temporarily stopped if necessary because of adverse events.

Participant Flow:   Overall Study

  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.
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Reporting Groups
Ziprasidone No text entered.

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   30 
>=65 years   0 
[Units: Years]
Mean (Standard Deviation)
 38.61  (13.34) 
[Units: Participants]
Female   21 
Male   9 
Region of Enrollment 
[Units: Participants]
United States   30 

  Outcome Measures
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1.  Primary:   The Primary Efficacy Endpoint is the Comparison of Baseline and Week 8 Endpoint in the 17-item HAM-D Total Scores   [ Time Frame: Week 8 ]

2.  Secondary:   Mean Change From Baseline in the Hamilton Anxiety Scale (HAM-A)   [ Time Frame: Week 8 ]

3.  Secondary:   Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale   [ Time Frame: Week 8 ]

4.  Secondary:   Percentage of Subjects With Clinical Global Inventory (CGI) Global Improvement Score of 1 or 2   [ Time Frame: Week 8 ]

5.  Secondary:   Mean Change From Baseline in the CGI-Severity of Illness (CGI-S) Score at Study Endpoint   [ Time Frame: Week 8 ]

6.  Secondary:   Mean Change From Baseline in the Total Score of the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)   [ Time Frame: Week 8 ]

7.  Secondary:   Mean Change From Baseline in the Total Score of the Beck Depression Inventory (BDI)   [ Time Frame: Week 8 ]

  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 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: Dr. Michael Liebowitz
Organization: The Medical Research Network, LLC
phone: (212) 595-5012

Responsible Party: The Medical Research Network Identifier: NCT00237666     History of Changes
Other Study ID Numbers: 04-3945-A 01
Study First Received: October 7, 2005
Results First Received: November 20, 2012
Last Updated: May 9, 2013