Treatment of Major Depressive Disorder With Psychotic Features.

This study has been terminated.
Janssen, LP
Information provided by:
Rush University Medical Center Identifier:
First received: September 9, 2005
Last updated: December 28, 2007
Last verified: December 2007
The purpose of this study is to determine the safety and efficacy of risperidone monotherapy in the treatment of psychotic depression. We hypothesize that risperidone is as equally as effective as haloperidol plus sertraline for depression with psychotic features

Condition Intervention Phase
Major Depression With Psychotic Features
Drug: risperidone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Treatment of Major Depressive Disorder With Psychotic Features With Risperidone Monotherapy; Risperidone and Sertraline; or Haloperidol and Sertraline

Resource links provided by NLM:

Further study details as provided by Rush University Medical Center:

Primary Outcome Measures:
  • Hamilton Depression Rating Scale

Secondary Outcome Measures:
  • Positive and Negative Symptom Scale

Estimated Enrollment: 30
Study Start Date: September 2001
Study Completion Date: August 2007
Detailed Description:
Risperidone is a novel antipsychotic that is usually not associated with the adverse effects of neuroleptics. In addition, preliminary evidence suggests that it has additional mood stabilizing properties as compared with neuroleptics. We are examining the effect of risperidone alone for the treatment of psychotic depression. After providing written informed consent, subjects with major depression and psychosis will undergo a routine medical and neurological evaluation. If subjects qualify they will undergo a 3 to 7 day washout. Subjects will be randomly assigned under double-blind conditions to risperidone plus placebo; risperidone plus sertraline; or haloperidol (HPDL) plus sertraline in a prospective parallel design for a 6 week trial. Outcome measures include the Hamilton Rating Depression Scale, The Positive and Negative Symptom Scale and the Clinician Administered Ratings Scale for Mania and Simpson Angus Scale. Rating will be conducted on a weekly basis throughout the study.

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects will be men and women 18 to 70 years of age with major depression and psychosis that is either an initial episode or a recurrent episode (unipolar or bipolar).
  • Subjects with an anxiety disorder or an additional mood disorder such as dysthymia are eligible.
  • Baseline HDRS score of greater than 21.
  • A baseline PANSS score of greater than 4 on at least one of the 5 psychosis items

Exclusion Criteria:

  • Pregnant women Women of child-bearing age who refuse a urine pregnancy test or who refuse to use a contraceptive technique when sexually active.
  • Persons with other psychotic disorders; a mood disorder due to a general medical condition or substance-induced; a current substance dependence disorder; or a dementing disorder are excluded.
  • Persons with serious, unstable medical illnesses.
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Please refer to this study by its identifier: NCT00174590

United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
Janssen, LP
Principal Investigator: Philip g Janicak, MD Rush University Medical Center
  More Information Identifier: NCT00174590     History of Changes
Other Study ID Numbers: RIS-USA-248 
Study First Received: September 9, 2005
Last Updated: December 28, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Rush University Medical Center:

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Mental Disorders
Psychotic Disorders
Behavioral Symptoms
Mood Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Antipsychotic Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Tranquilizing Agents processed this record on May 26, 2016