Study of Pharmacotherapy of Psychotic Depression (STOP-PD)

June 26, 2013 updated by: Weill Medical College of Cornell University

Effectiveness of Selective Serotonin Reuptake Inhibitors Combined With Antipsychotic Medication for the Treatment of Psychotic Depression

This study will determine the effectiveness of combining selective serotonin reuptake inhibitors (SSRIs) with antipsychotic medications in the treatment of psychotic depression.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Approximately 25% of people who are admitted to hospitals for depression suffer from psychotic depression. People with psychotic depression experience hallucinations,and, more commonly delusions, in addition to major depression. Psychotic experiences may be either congruent with the theme of depression or incongruent, without an apparent relationship to feeling depressed. This study will determine the effectiveness of combining a selective serotonin reuptake inhibitor (SSRI) with antipsychotic medication in the treatment of psychotic depression accompanied by at least one identifiable delusion. The study will also evaluate the difference in treatment response of young adults versus geriatric patients.

This double-blind study will last a total of 12 weeks. Participants will be randomly assigned to receive either olanzapine, an atypical antipsychotic drug, combined with sertraline, an SSRI, or olanzapine alone. Following baseline assessments, study visits will occur weekly until Week 6, and then bi-weekly until Week 12. Participants who do not respond to either treatment may leave the study at any time. Participants who achieve either partial or full response may participate in an additional 20-week study.

Study Type

Interventional

Enrollment (Actual)

259

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • University of Toronto
  • United States
    • Massachusetts
      • Worcester, Massachusetts, United States, 01605
        • University of Massachusetts Medical School
    • New York
      • New York, New York, United States, 10021
        • Cornell University
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Major depressive disorder, single or recurrent, with psychotic features

Exclusion Criteria:

  • History of substance abuse or dependence within the 3 months prior to enrollment
  • Acute or unstable medical illness
  • Diagnosis of schizophrenia or other psychotic disorders
  • Pregnant
  • Intolerance to SSRIs or olanzapine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: olanzapine/sertraline combination
sertraline plus olanzapine
Drug: Olanzapine
10-20mg/day
Other Names:
  • Zyprexa
Drug: Sertraline
150-200mg/day
Other Names:
  • Zoloft
Placebo Comparator: olanzapine plus placebo
olanzapine (5 - 20mg/day) plus placebo
Drug: Olanzapine
10-20mg/day
Other Names:
  • Zyprexa
Other: placebo
tablet that ressembles sertraline but contains no medication

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

Remission was defined as scores on Ham-D of less than 10 at two consecutive assessments and the absence of delusions (measured as SADS delusional item scores of 1) at the second assessment of the two-assessment remission of depression interval.

Scores on Ham-D range from 0 to 52 with higher scores indicating more severe depression. Scores on SADS range from 1 to 7 with higher scores indicating the delusions(s) more adversely effect the subject's behavior.
Weeks 1 to 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Scores on CGI-S Compared to Baseline Over the Course of the Trial
Time Frame: Weeks 1 to 12
A measure of overall symptom severity, the Clinical Global Impressions, Severity of Illness Scale (CGI-S). It is a seven point scale with a one indicating not at all ill, and seven indicating the most extremely ill. This rating was done each week after baseline by the PI at each site after visiting with the patient.
Weeks 1 to 12

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Score Hamilton Depression Rating Scale (Ham-D) Over the Course of the Trial From Week to Week.
Time Frame: Weeks 1 to 12
The Ham-D measures depression severity. Scores on Ham-D range from 0 to 52 with higher scores indicating more severe depression.
Weeks 1 to 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Barnett Meyers, MD, Cornell University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

March 14, 2003

First Submitted That Met QC Criteria

March 14, 2003

First Posted (Estimate)

March 17, 2003

Study Record Updates

Last Update Posted (Estimate)

August 2, 2013

Last Update Submitted That Met QC Criteria

June 26, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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