Study of Pharmacotherapy of Psychotic Depression (STOP-PD)
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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 Depression With Psychotic Features |
Drug: Olanzapine Drug: Sertraline |
Phase 3 |
| 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 |
| Official Title: | Effectiveness of Selective Serotonin Reuptake Inhibitors Combined With Antipsychotic Medication for the Treatment of Psychotic Depression |
- Remission of depression (Hamilton Depression Scale) and psychosis (Schedule for Affective Disorders in Schizophrenia - delusional item) during the course of the trial [ Time Frame: Weeks 1-6, 8, 10, 12 ] [ Designated as safety issue: No ]
- CGI-S scores over the course of the trial [ Time Frame: Weeks 1-6, 8,10,12 ] [ Designated as safety issue: Yes ]
| 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: 1
sertraline plus olanzapine
|
Drug: Olanzapine
10-20mg/day
Other Name: Zyprexa
Drug: Sertraline
150-200mg/day
Other Name: Zoloft
|
|
Placebo Comparator: 2
sertraline placebo plus olanzapine
|
Drug: Olanzapine
10-20mg/day
Other Name: Zyprexa
|
Detailed Description:
Approximately 25% of people who are admitted to hospitals for depression suffer from psychotic depression. People with psychotic depression experience not only the standard symptoms of depression, but also hallucinations and delusions. They also often become paranoid, believe that their thoughts are not their own, or think that others can hear their thoughts. This study will determine the effectiveness of combining selective serotonin reuptake inhibitors (SSRIs) with antipsychotic medications in the treatment of psychotic depression. 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 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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| 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 | |
| Principal Investigator: | Barnett Meyers, MD | Cornell University |
More Information
No publications provided by National Institute of Mental Health (NIMH)
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Barnett Meyers, M.D., Weill Medical College of Cornell University |
| ClinicalTrials.gov Identifier: | NCT00056472 History of Changes |
| Other Study ID Numbers: | U01 MH62624, DATR A4-GPX, U01 MH62565, U01 MH62518, U01 MH62446 |
| Study First Received: | March 14, 2003 |
| Last Updated: | August 20, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Mental Health (NIMH):
|
Major depressive disorder with psychotic features Delusional Depression Randomized Trial |
Combination Treatment SSRI Atypical Antipsychotic |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Mental Disorders Psychotic Disorders Depressive Disorder, Major Bipolar Disorder Behavioral Symptoms Mood Disorders Schizophrenia and Disorders with Psychotic Features Affective Disorders, Psychotic Antipsychotic Agents Olanzapine Sertraline Serotonin Uptake Inhibitors Tranquilizing Agents |
Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Antidepressive Agents Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents |
ClinicalTrials.gov processed this record on May 22, 2013