- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00174590
Treatment of Major Depressive Disorder With Psychotic Features.
December 28, 2007 updated by: Rush University Medical Center
Treatment of Major Depressive Disorder With Psychotic Features With Risperidone Monotherapy; Risperidone and Sertraline; or Haloperidol and Sertraline
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
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment
30
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
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Illinois
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Chicago, Illinois, United States, 60612
- Rush University Medical Center
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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
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
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: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Hamilton Depression Rating Scale
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Secondary Outcome Measures
Outcome Measure |
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Positive and Negative Symptom Scale
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Philip G Janicak, MD, Rush University Medical Center
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
September 1, 2001
Study Completion (Actual)
August 1, 2007
Study Registration Dates
First Submitted
September 9, 2005
First Submitted That Met QC Criteria
September 9, 2005
First Posted (Estimate)
September 15, 2005
Study Record Updates
Last Update Posted (Estimate)
January 10, 2008
Last Update Submitted That Met QC Criteria
December 28, 2007
Last Verified
December 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mood Disorders
- Schizophrenia Spectrum and Other Psychotic Disorders
- Depression
- Depressive Disorder
- Psychotic Disorders
- Mental Disorders
- Depressive Disorder, Major
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Dopamine Agents
- Serotonin Antagonists
- Dopamine Antagonists
- Risperidone
Other Study ID Numbers
- RIS-USA-248
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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Clinical Trials on risperidone
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