Study of Pharmacotherapy of Psychotic Depression (STOP-PD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00056472
Recruitment Status : Completed
First Posted : March 17, 2003
Results First Posted : August 2, 2013
Last Update Posted : August 2, 2013
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Weill Medical College of Cornell University

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 With Psychotic Features
Interventions: Drug: Olanzapine
Drug: Sertraline
Other: 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
Subjects were recruited from the inpatient and outpatient services of four academic sites between December of 2002 and June of 2007.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Antidepressant and antipsychotic medications being taken at entry were tapered and discontinued prior to randomization. Consented subjects were required to meet criteria for unipolar major depression and have at least one delusion. Subjects were also excluded if an unstable medical condition or evidence of recent substance abuse were present.

Reporting Groups
Sertraline Plus Olanzapine 50-200mg/day sertraline plus 5-20mg/day olanzapine
Olanzapine Plus Placebo 5-20mg/day olanzapine plus placebo

Participant Flow:   Overall Study
    Sertraline Plus Olanzapine   Olanzapine Plus Placebo
STARTED   129   130 
COMPLETED   81   61 
NOT COMPLETED   48   69 

  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
Pharmacotherapy sertraline plus olanzapine
Monotherapy placebo plus olanzapine
Total Total of all reporting groups

Baseline Measures
   Pharmacotherapy   Monotherapy   Total 
Overall Participants Analyzed 
[Units: Participants]
 129   130   259 
[Units: Participants]
<=18 years   0   1   1 
Between 18 and 65 years   77   73   150 
>=65 years   52   56   108 
[Units: Participants]
Female   83   83   166 
Male   46   47   93 
Region of Enrollment 
[Units: Participants]
United States   89   89   178 
Canada   40   41   81 

  Outcome Measures

1.  Primary:   Remission of Depression Hamilton Depression Scale (Ham-D) and Psychosis Schedule for Affective Disorders in Schizophrenia - Delusional Item (SADS) During the Course of the Trial   [ Time Frame: Weeks 1 to 12 ]

2.  Secondary:   Scores on CGI-S Compared to Baseline Over the Course of the Trial   [ Time Frame: Weeks 1 to 12 ]

3.  Other Pre-specified:   Mean Score Hamilton Depression Rating Scale (Ham-D) Over the Course of the Trial From Week to Week.   [ Time Frame: Weeks 1 to 12 ]

  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: Barnett S. Meyers, MD
Organization: Weill Cornell Medical College
phone: 914-997-5721

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

Responsible Party: Weill Medical College of Cornell University Identifier: NCT00056472     History of Changes
Other Study ID Numbers: U01MH062624 ( U.S. NIH Grant/Contract )
U01MH062624 ( U.S. NIH Grant/Contract )
U01MH062565 ( U.S. NIH Grant/Contract )
U01MH062518 ( U.S. NIH Grant/Contract )
U01MH062446 ( U.S. NIH Grant/Contract )
First Submitted: March 14, 2003
First Posted: March 17, 2003
Results First Submitted: June 16, 2009
Results First Posted: August 2, 2013
Last Update Posted: August 2, 2013