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Study of Pharmacotherapy of Psychotic Depression (STOP-PD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00056472
First Posted: March 17, 2003
Last Update Posted: August 2, 2013
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.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Weill Medical College of Cornell University
  Purpose
This study will determine the effectiveness of combining selective serotonin reuptake inhibitors (SSRIs) with antipsychotic medications in the treatment of psychotic depression.

Condition Intervention Phase
Major Depressive Disorder With Psychotic Features Drug: Olanzapine Drug: Sertraline Other: placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Selective Serotonin Reuptake Inhibitors Combined With Antipsychotic Medication for the Treatment of Psychotic Depression

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Enrollment: 259
Study Start Date: January 2003
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: olanzapine/sertraline combination
sertraline plus olanzapine
Drug: Olanzapine
10-20mg/day
Other Name: Zyprexa
Drug: Sertraline
150-200mg/day
Other Name: Zoloft
Placebo Comparator: olanzapine plus placebo
olanzapine (5 - 20mg/day) plus placebo
Drug: Olanzapine
10-20mg/day
Other Name: Zyprexa
Other: placebo
tablet that ressembles sertraline but contains no medication

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00056472


Locations
United States, Massachusetts
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01605
United States, New York
Cornell University
New York, New York, United States, 10021
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Canada, Ontario
University of Toronto
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
Weill Medical College of Cornell University
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Barnett Meyers, MD Cornell University
  More Information

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

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov 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 )
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
Last Verified: June 2013

Keywords provided by Weill Medical College of Cornell University:
Major depressive disorder with psychotic features
Delusional Depression
Randomized Trial
Combination Treatment
SSRI
Atypical Antipsychotic

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Mental Disorders
Psychotic Disorders
Behavioral Symptoms
Mood Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Antipsychotic Agents
Olanzapine
Sertraline
Serotonin Uptake Inhibitors
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Antidepressive Agents