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A 12-Week, Placebo Controlled Trial of Ziprasidone as Monotherapy for Major Depressive Disorder (Geodon)

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ClinicalTrials.gov Identifier: NCT00555997
Recruitment Status : Completed
First Posted : November 9, 2007
Results First Posted : July 3, 2014
Last Update Posted : July 3, 2014
Sponsor:
Collaborators:
Cambridge Health Alliance
University of Connecticut
Vanderbilt University
Psychiatric Medicine Associates, L.L.C.
Cedars-Sinai Medical Center
Information provided by (Responsible Party):
George I. Papakostas, Massachusetts General Hospital

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Major Depressive Disorder
Interventions: Drug: Ziprasidone
Drug: Placebo

  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
No text entered.

Reporting Groups
  Description
Phase 1 Ziprasidone Subjects taking ziprasidone in the first phase.
Phase 1 Placebo Subjects taking placebo in the first phase.
Phase 2 Ziprasidone Subjects taking ziprasidone in the second phase.
Phase 2 Placebo Patients who received placebo in phase 2.

Participant Flow for 2 periods

Period 1:   Phase 1 SPCD
    Phase 1 Ziprasidone   Phase 1 Placebo   Phase 2 Ziprasidone   Phase 2 Placebo
STARTED   29   91   0   0 
COMPLETED   17   76   0   0 
NOT COMPLETED   12   15   0   0 

Period 2:   Phase 2 SPCD
    Phase 1 Ziprasidone   Phase 1 Placebo   Phase 2 Ziprasidone   Phase 2 Placebo
STARTED   0   0   38   25 
COMPLETED   0   0   31   22 
NOT COMPLETED   0   0   7   3 



  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
Placebo/Ziprasidone Received placebo in first phase and ziprasidone in second phase
Placebo Subjects received placebo throughout study
Ziprasidone Subjects received ziprasidone throughout study
Total Total of all reporting groups

Baseline Measures
   Placebo/Ziprasidone   Placebo   Ziprasidone   Total 
Overall Participants Analyzed 
[Units: Participants]
 47   44   29   120 
Age 
[Units: Participants]
       
<=18 years   0   0   0   0 
Between 18 and 65 years   47   42   29   118 
>=65 years   0   2   0   2 
Age 
[Units: Years]
Mean (Standard Deviation)
 44.1  (11.1)   44.6  (11.0)   41.5  (10.6)   43.7  (11.0) 
Gender 
[Units: Participants]
       
Female   18   22   13   53 
Male   29   22   16   67 
Region of Enrollment 
[Units: Participants]
       
United States   47   44   29   120 


  Outcome Measures

1.  Primary:   Hamilton Depression Rating Scale (HAM-D-17) Scores   [ Time Frame: 6 weeks ]

2.  Secondary:   Responder/Non-responder   [ Time Frame: 6 weeks ]

3.  Secondary:   Change in 6-VAS-D Scores During Each Phase.   [ Time Frame: 6 weeks ]


  Serious Adverse Events


  Other Adverse Events


  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

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. George Papakostas
Organization: Massachusetts General Hospital
phone: 617-726-6697
e-mail: gpapakostas@partners.org


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

Responsible Party: George I. Papakostas, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00555997     History of Changes
Obsolete Identifiers: NCT00657592
Other Study ID Numbers: 2007-P-000623
First Submitted: November 7, 2007
First Posted: November 9, 2007
Results First Submitted: July 9, 2013
Results First Posted: July 3, 2014
Last Update Posted: July 3, 2014