- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00158028
Risperidone in the Treatment of Psychotic-like and Deficit Symptoms of Schizotypal Personality Disorder
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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. They include the Clinical Global Impression scale (CGI), the Scale for the Assessment of Negative Symptoms (SANS), the Positive and Negative Symptom Scale (PANSS), and the Hamilton Depression Rating Scale (HDRS), all administered weekly. At baseline and after 4- and 9-weeks of treatment, subjects will also receive a series of paper-and-pencil and computer-presented cognitive tests (DOT test, Paced Auditory Serial Addition Task, Continuous Performance Task-Identical Pairs version, Serial Verbal Learning Test and the Wechsler memory Scale-Revised Visual Reproduction test). No medications, other than study drug, are allowed during the protocol. If, during this two-week placebo washout period, the total SANS score decreases by 35% or greater, patients will not be entered into Phase 2. Use of a placebo washout is not part of standard clinical care.
PART 2 Part 2 is the double blind, 9-week parallel-arm placebo-controlled portion of the study. Randomization will be conducted by the Pharmacy. One week of medication (active or placebo) will be dispensed at a time by a research program physician under the direct supervision of Dr. Koenigsberg. The patient will receive 1 tablet PO QD every day of the study. If enrolled in the Active Arm of the study, the patient will receive a .25 mg risperidone tablet orally once daily for Days 1 to 7; .5 mg risperidone tablet orally once daily for Days 8 to 21; 1 mg risperidone tablet orally once daily for Days 22-35; 1.5 mg risperidone tablet orally once daily for days 36-49; and a 2 mgs of risperidone orally once daily for days 50 to 63. If the treating psychiatrist believes that a higher dose is clinically indicated, the physician may alter the above by increasing the dose to 2 mg per day beginning on day 22 and to 4 mg per day beginning on day 50. Weekly visits will include standard assessment and review of protocol compliance. Treatment with risperidone is not part of current standard clinical care of schizotypal personality disorder and this study is designed to establish its usefulness with this population. Similarly use of a double bind placebo control is not part of standard clinical care.
PART 3 Patients who were randomized into the placebo arm of Part 2 will be offered the opportunity of participating in an 8 week open label study of risperidone otherwise identical to Part 2.
Data will be analyzed by a repeated measures analysis of variance separately for scores on the CGI, SANS, PANSS, and HDSR comparing placebo and active medication.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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New York
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Bronx, New York, United States, 10029
- Bronx VA
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Schizotypal Personality Disorder
Exclusion Criteria:
Over 65
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Risperidone
starting dose 0.25mg/day, titrated upward to 2mg/day over 9 weeks
|
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
|
placebo match in identical tablets
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Positive and Negative Symptom Scale (PANAS) rating
|
Secondary Outcome Measures
Outcome Measure |
---|
Clinical global Impression, Schizotypal Persoality Questionarre Score, CPT-IP, Paced Auditory Serial Addition Task, Wechsler memory scale-Revised Visual Reproduction; Serial Verbal Learning Test
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Harold Koenigsberg, Mount Sinai School of Medicine/Bronx VA
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Personality Disorders
- Disease
- Schizotypal Personality Disorder
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Dopamine Agents
- Serotonin Antagonists
- Dopamine Antagonists
- Risperidone
Other Study ID Numbers
- GCO 94-561
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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