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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00158028
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : August 4, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Schizotypal Personality Disorder Drug: Risperidone Drug: Placebo

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Risperidone in the Treatment of Psychotic-like and Deficit Symptoms of Schizotypal Personality Disorder
Study Start Date : November 1995
Primary Completion Date : December 2001
Study Completion Date : December 2001

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
Experimental: Risperidone
starting dose 0.25mg/day, titrated upward to 2mg/day over 9 weeks
Drug: Risperidone
The dosage of risperidone was titrated upward in a stepwise design, beginning with 0.25 mg/d for the first week, 0.5 mg/d for weeks 2 and 3, 1.0 mg/d for weeks 4 and 5, 1.5 mg/d for weeks 6 and 7, and 2.0 mg/d for the remaining weeks.
Placebo Comparator: Placebo
placebo match in identical tablets
Drug: Placebo
placebo match in identical tablets

Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Schizotypal Personality Disorder

Exclusion Criteria:

Over 65

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00158028

United States, New York
Bronx VA
Bronx, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Janssen Pharmaceutica
Principal Investigator: Harold Koenigsberg Mount Sinai School of Medicine/Bronx VA
More Information

Responsible Party: Harold W Koenigsberg, Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT00158028     History of Changes
Other Study ID Numbers: GCO 94-561
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: August 4, 2016
Last Verified: August 2016

Keywords provided by Harold W Koenigsberg, Icahn School of Medicine at Mount Sinai:
Schizotypal Personality Disorder

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