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Risperidone in the Treatment of Psychotic-Like and Deficit Symptoms of Schizotypal Personality Disorder

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Mount Sinai School of Medicine.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Janssen Pharmaceutica N.V., Belgium
Information provided by:
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT00158028
First received: September 8, 2005
Last updated: November 21, 2005
Last verified: September 2005
History of Changes
  Purpose

The purpose of this study is to determine the efficacy of risperidone compared to placebo in the treatment of the psychotic-like and deficit symptoms of schizotypal personality disorder (SPD). Treatment with risperidone, a 5HT2 and dopamine D2 blocking agent, holds particular promise in the treatment of SPD. Unlike traditional antipsychotics, risperidone targets the deficit or negative symptoms of schizophrenia. The deficit-like symptoms of SPD are therefore also likely respond to treatment with risperidone. One common complication in the present psychopharmacologic treatment of SPD with traditional neuroleptics is the fact that many patients discontinue treatment due to the medication-induced dysphoria. Given initial reports and the serotonergic component of the risperidone mechanism, risperidone is anticipated to produce little or no dysphoria.


Condition Intervention
Schizotypal Personality Disorder
 Drug: Respiridone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Risperidone in the Treatment of Psychotic-Like and Deficit Symptoms of Schizotypal Personality Disorder

Resource links provided by NLM:

Drug Information available for: Risperidone
U.S. FDA Resources

Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Positive and Negative Symptom Scale (PANAS) rating

Secondary Outcome Measures:
  • Clinical global Impression, Schizotypal Persoality Questionarre Score, CPT-IP, Paced Auditory Serial Addition Task, Wechsler memory scale-Revised Visual Reproduction; Serial Verbal Learning Test

Estimated Enrollment: 30
Study Start Date: November 1995
Estimated Study Completion Date: March 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Schizotypal Personality Disorder

Exclusion Criteria:

Over 65

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00158028

Locations
United States, New York
Bronx VA
Bronx, New York, United States, 10029
Sponsors and Collaborators
Mount Sinai School of Medicine
Janssen Pharmaceutica N.V., Belgium
Investigators
Principal Investigator: Harold Koenigsberg Koenigsberg Mount Sinai School of Medicine/Bronx VA
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00158028     History of Changes
Other Study ID Numbers: GCO# 94-561
Study First Received: September 8, 2005
Last Updated: November 21, 2005
Health Authority: United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
Schizotypal Personality Disorder
Risperidone
Treatment
Cognitive

Additional relevant MeSH terms:
Personality Disorders
Schizotypal Personality Disorder
Mental Disorders
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on May 23, 2013