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

This study has been completed.
Janssen Pharmaceutica
Information provided by (Responsible Party):
Harold W Koenigsberg, Icahn School of Medicine at Mount Sinai Identifier:
First received: September 8, 2005
Last updated: August 2, 2016
Last verified: August 2016
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: Risperidone
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Risperidone in the Treatment of Psychotic-like and Deficit Symptoms of Schizotypal Personality Disorder

Resource links provided by NLM:

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

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

Enrollment: 25
Study Start Date: November 1995
Study Completion Date: December 2001
Primary Completion Date: December 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description


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

Inclusion Criteria:

Schizotypal Personality Disorder

Exclusion Criteria:

Over 65

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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 Identifier: NCT00158028     History of Changes
Other Study ID Numbers: GCO 94-561 
Study First Received: September 8, 2005
Last Updated: August 2, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by 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 processed this record on October 21, 2016