Study of Pharmacotherapy of Psychotic Depression - Full Text View

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00056472

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Effectiveness of Selective Serotonin Reuptake Inhibitors Combined With Antipsychotic Medication for the Treatment of Psychotic Depression

Resource links provided by NLM:

MedlinePlus related topics: Depression Psychotic Disorders

Drug Information available for: Serotonin Sertraline hydrochloride Sertraline Olanzapine

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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
1: Active Comparator sertraline plus olanzapine	Drug: Olanzapine 10-20mg/day Drug: Sertraline 150-200mg/day
2: Placebo Comparator sertraline placebo plus olanzapine	Drug: Olanzapine 10-20mg/day

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

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

Please refer to this study by its ClinicalTrials.gov identifier: 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

National Institute of Mental Health (NIMH)

Investigators

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 National Clinical Trials Identifier (NCT ID):

Meyers BS, Flint AJ, Rothschild AJ, Mulsant BH, Whyte EM, Peasley-Miklus C, Papademetriou E, Leon AC, Heo M; STOP-PD Group. A double-blind randomized controlled trial of olanzapine plus sertraline vs olanzapine plus placebo for psychotic depression: the study of pharmacotherapy of psychotic depression (STOP-PD). Arch Gen Psychiatry. 2009 Aug;66(8):838-47.

Schaffer A, Flint AJ, Smith E, Rothschild AJ, Mulsant BH, Szanto K, Peasley-Miklus C, Heo M, Papademetriou E, Meyers BS. Correlates of suicidality among patients with psychotic depression. Suicide Life Threat Behav. 2008 Aug;38(4):403-14.

Smith E, Rothschild AJ, Heo M, Peasley-Miklus C, Caswell M, Papademetriou E, Flint AJ, Mulsant BH, Meyers BS; STOP-PD Collaborative Study Group. Weight gain during olanzapine treatment for psychotic depression: effects of dose and age. Int Clin Psychopharmacol. 2008 May;23(3):130-7.

Rothschild AJ, Winer J, Flint AJ, Mulsant BH, Whyte EM, Heo M, Fratoni S, Gabriele M, Kasapinovic S, Meyers BS; Study of Pharmacotherapy of Psychotic Depression (STOP-PD) Collaborative Study Group. Missed diagnosis of psychotic depression at 4 academic medical centers. J Clin Psychiatry. 2008 Aug;69(8):1293-6.

Andreescu C, Mulsant BH, Peasley-Miklus C, Rothschild AJ, Flint AJ, Heo M, Caswell M, Whyte EM, Meyers BS; STOP-PD Study Group. Persisting low use of antipsychotics in the treatment of major depressive disorder with psychotic features. J Clin Psychiatry. 2007 Feb;68(2):194-200.

Responsible Party:	Weill Medical College of Cornell University ( Barnett Meyers, M.D. )
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
ClinicalTrials.gov Identifier:	NCT00056472 History of Changes
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:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Olanzapine
Psychotropic Drugs
Antiemetics
Depressive Disorder, Major
Affective Disorders, Psychotic
Mental Disorders
Therapeutic Uses
Sertraline
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features
Antidepressive Agents

Depression
Tranquilizing Agents
Bipolar Disorder
Gastrointestinal Agents
Central Nervous System Depressants
Antipsychotic Agents
Depressive Disorder
Serotonin Uptake Inhibitors
Pharmacologic Actions
Behavioral Symptoms
Serotonin Agents
Autonomic Agents
Mood Disorders
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010