NCT00158028|Completed
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Sponsor study identifier
interventional
25
1 country
1
Study Start
November 1995
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2001
Actual (reported)Study Completion
December 2001
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2001
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 1995
Date type not reportedThis date has not been verified as actual or estimated.
December 2001
Actual (reported)December 2001
Actual (reported)September 8, 2005
Actual (reported)September 12, 2005
Actual (reported)Positive and Negative Symptom Scale (PANAS) rating
Clinical global Impression, Schizotypal Persoality Questionarre Score, CPT-IP, Paced Auditory Serial Addition Task, Wechsler memory scale-Revised Visual Reproduction; Serial Verbal Learning Test
starting dose 0.25mg/day, titrated upward to 2mg/day over 9 weeks
placebo match in identical tablets
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 match in identical tablets
Bronx VA
The Bronx, New York, 10029, United States
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.
Harold Koenigsberg
Mount Sinai School of Medicine/Bronx VA
25 participants (actual enrollment reported by the registry).
First Submitted
September 8, 2005
First Posted
September 12, 2005
Study Start
November 1995
Date type not reportedThis date has not been verified as actual or estimated.
Evolutionary Systems Therapy for Schizotypy
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
December 2001
Actual (reported)Study Completion
December 2001
Actual (reported)Last Updated
August 4, 2016
Record last verified: 2016-08
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Source: ClinicalTrials.gov.
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