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Study of Pharmacotherapy of Psychotic Depression (STOP-PD)

This study has been completed.
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Weill Medical College of Cornell University Identifier:
First received: March 14, 2003
Last updated: June 26, 2013
Last verified: June 2013
Results First Received: June 16, 2009  
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
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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
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
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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
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
  Show All 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
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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: 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 )
U01MH062565 ( U.S. NIH Grant/Contract )
U01MH062518 ( U.S. NIH Grant/Contract )
U01MH062446 ( U.S. NIH Grant/Contract )
Study First Received: March 14, 2003
Results First Received: June 16, 2009
Last Updated: June 26, 2013