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;   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
  Hide Participant Flow

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
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
  Hide Baseline Characteristics

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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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
  Hide 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.


  More Information
  Hide More Information

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


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

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