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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary:

All patients receive a comprehensive medical evaluation prior to their participation in any studies, as part of their normal clinical care. The evaluation includes an extensive medical history, physical examination, and laboratory evaluation including SMA-18, CBC with differential, TFT's, U/A, stool guaiac, serology, drug screen, chest X-ray (where indicated), EKG, and, for women, pregnancy test. [Note: Subjects will have consented to these procedures in a separate consent, "Biological Correlates of Personality Disorder- Information for Subjects (88244)", before being invited to join this study.] Patients will be interviewed by clinical psychology doctoral students trained in the use of structured instruments to assess Axis I and Axis II pathology. A rater will independently complete either the Schedule for Affective Disorders and Schizophrenia (SADS) (Spitzer & Endicott 1978), modified for evaluation of DSM-IV criteria for Axis 1 disorders, or the Structured Clinical Interview for DSM-IV Axis I Disorders ( First et al 1996) and the Structured Interview for DSM-III-R Personality Disorders (SIDP-R) (Pfohl et al 1989) also modified for the evaluation of DSM-IV criteria. When possible, information will be gathered independently from an informant (first degree relative or life-long friend) to supplement information obtained from clinical interviews and review of past records. The use of structured interviews, and questionnaires are not part of standard clinical care.

PART 1 Part 1 is a single-blind two-week placebo washout. Patients will be seen weekly by a research psychiatrist. One week of (placebo) medication will be dispensed at a time by a research program physician under the direct supervision of Dr. Koenigsberg. Patients will be seen weekly throughout the study. Interviews and assessments are standardized and identical throughout all phases of the study.
Sponsor: Icahn School of Medicine at Mount Sinai

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

Original Primary Outcome: Same as current

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

Original Secondary Outcome: Same as current

Information By: Icahn School of Medicine at Mount Sinai

Dates:
Date Received: September 8, 2005
Date Started: November 1995
Date Completion:
Last Updated: August 2, 2016
Last Verified: August 2016