Study of Pharmacotherapy of Psychotic Depression (STOP-PD)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00056472
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;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, 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
  Description
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.
No text entered.

Reporting Groups
  Description
Pharmacotherapy sertraline plus olanzapine
Monotherapy placebo plus olanzapine
Total Total of all reporting groups

Baseline Measures
    Pharmacotherapy     Monotherapy     Total  
Number of Participants  
[units: participants]
  129     130     259  
Age  
[units: participants]
     
<=18 years     0     1     1  
Between 18 and 65 years     77     73     150  
>=65 years     52     56     108  
Gender  
[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


  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.


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.  


Results Point of Contact:  
Name/Title: Barnett S. Meyers, MD
Organization: Weill Cornell Medical College
phone: 914-997-5721
e-mail: bmeyers@med.cornell.edu


No publications provided by Weill Medical College of Cornell University

Publications automatically indexed to this study:


Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00056472     History of Changes
Other Study ID Numbers: U01 MH62624, U01MH062624, U01 MH62565, U01 MH62518, U01 MH62446
Study First Received: March 14, 2003
Results First Received: June 16, 2009
Last Updated: June 26, 2013
Health Authority: United States: Federal Government