Ziprasidone Augmentation of SSRIs for Patients With Major Depressive Disorder (MDD) That do Not Sufficiently Respond to Treatment With SSRIs

This study has been completed.
Sponsor:
Collaborator:
University of Alabama at Birmingham
Information provided by (Responsible Party):
George I. Papakostas, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00633399
First received: March 4, 2008
Last updated: June 24, 2014
Last verified: June 2014
Results First Received: June 24, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Major Depressive Disorder
Interventions: Drug: 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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
458 patients met eligibility criteria for the study and were enrolled in an 8-week, open-label, flexible dose trial of escitalopram. At the end of this open-label trial, 139 patients not responding to Escitalopram were randomized to receive adjunctive ziprasidone or adjunctive placebo.

Reporting Groups
  Description
Ziprasidone + Escitalopram

Patients in group 1 will receive Ziprasidone added to Escitalopram for the full 8 weeks of Phase 2.

Ziprasidone: 20mg-80mg a day. Dose increases of 20mg per day may occur at three study visits as directed by clinician. Maximum; 80mg per day per patient.

Placebo + Escitalopram

Patients in group 2 will receive Placebo added to Escitalopram for the full 8 weeks of Phase 2.

Placebo: 0mg Placebo per day (1-4 tablets per day). "Dose increases" and "dose decreases" may occur, but patient will remain at 0mg placebo.


Participant Flow:   Overall Study
    Ziprasidone + Escitalopram     Placebo + Escitalopram  
STARTED     71     68  
COMPLETED     49     53  
NOT COMPLETED     22     15  



  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 + Escitalopram

Patients in group 1 will receive Ziprasidone added to Escitalopram for the full 8 weeks of Phase 2.

Ziprasidone: 20mg-80mg a day. Dose increases of 20mg per day may occur at three study visits as directed by clinician. Maximum; 80mg per day per patient.

Placebo + Escitalopram

Patients in group 2 will receive Placebo added to Escitalopram for the full 8 weeks of Phase 2.

Placebo: 0mg Placebo per day (1-4 tablets per day). "Dose increases" and "dose decreases" may occur, but patient will remain at 0mg placebo.

Total Total of all reporting groups

Baseline Measures
    Ziprasidone + Escitalopram     Placebo + Escitalopram     Total  
Number of Participants  
[units: participants]
  71     68     139  
Age  
[units: Years]
Mean ± Standard Deviation
  44.7  ± 13.8     44.2  ± 11.0     44.5  ± 12.9  
Gender  
[units: participants]
     
Female     49     49     98  
Male     22     19     41  
Region of Enrollment  
[units: participants]
     
United States     71     68     139  



  Outcome Measures
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1.  Primary:   The Primary Outcome Measure Will be Response Rates (50% Decrease in HAM-D-17 Scores) During Phase 2   [ Time Frame: 8 Weeks ]

2.  Secondary:   Remission Rates (HAM-D 17 Scores of Less Than 8) After Treatment Phase 2.   [ Time Frame: 8 weeks ]

3.  Secondary:   Comparing Scores on HAM-D 17 Baseline Visit to Phase 2 Final Visit at Week 8   [ Time Frame: 8 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
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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: George I Papakostas, M.D. - Scientific Director
Organization: Massachusetts General Hospital CNTI
phone: 6177266697
e-mail: gpapakostas@partners.org


No publications provided


Responsible Party: George I. Papakostas, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00633399     History of Changes
Other Study ID Numbers: 2007-P-002361
Study First Received: March 4, 2008
Results First Received: June 24, 2014
Last Updated: June 24, 2014
Health Authority: United States: Food and Drug Administration