Risperidone in the Treatment of Psychotic-like and Deficit Symptoms of Schizotypal Personality Disorder
1 other identifier
interventional
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 1995
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 1995
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2001
CompletedFirst Submitted
Initial submission to the registry
September 8, 2005
CompletedFirst Posted
Study publicly available on registry
September 12, 2005
CompletedAugust 4, 2016
August 1, 2016
6.1 years
September 8, 2005
August 2, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Positive and Negative Symptom Scale (PANAS) rating
Secondary Outcomes (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
Study Arms (2)
Risperidone
EXPERIMENTALstarting dose 0.25mg/day, titrated upward to 2mg/day over 9 weeks
Placebo
PLACEBO COMPARATORplacebo match in identical tablets
Interventions
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.
Eligibility Criteria
You may qualify if:
- Schizotypal Personality Disorder
You may not qualify if:
- Over 65
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Icahn School of Medicine at Mount Sinailead
- Janssen Pharmaceuticacollaborator
Study Sites (1)
Bronx VA
The Bronx, New York, 10029, United States
Related Publications (1)
Koenigsberg HW, Reynolds D, Goodman M, New AS, Mitropoulou V, Trestman RL, Silverman J, Siever LJ. Risperidone in the treatment of schizotypal personality disorder. J Clin Psychiatry. 2003 Jun;64(6):628-34. doi: 10.4088/jcp.v64n0602.
PMID: 12823075RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Harold Koenigsberg
Mount Sinai School of Medicine/Bronx VA
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 8, 2005
First Posted
September 12, 2005
Study Start
November 1, 1995
Primary Completion
December 1, 2001
Study Completion
December 1, 2001
Last Updated
August 4, 2016
Record last verified: 2016-08