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Pergolide for Cognitive Symptoms in Schizotypal Personality Disorder

Primary Purpose

Schizotypal Personality Disorder, Other Personality Disorders

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pergolide
Sponsored by
Bronx VA Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Schizotypal Personality Disorder

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: DSM-IV criteria for Schizotypal Personality Disorder (or meets full criteria bar one) or another personality disorder and shows impairment on markers of cognitive functioning. Medically healthy, not abusing drugs or alcohol, is at least two weeks medication-free and does not have significant neurological disease. - Exclusion Criteria: DSM-IV or RDC criteria for Schizophrenia or any Schizophrenia-related psychotic disorder or for Bipolar Disorder. Any other Axis I disorders must be transient and preceded by the personality disorder diagnosis, which should be primarily responsible for subject's functional impairment. -

Sites / Locations

  • Mount Sinai School of MedicineRecruiting

Outcomes

Primary Outcome Measures

Performance on tests of sustained attention, episodic memory and working memory at baseline and after 2, 4, 6 and 8 weeks on the study medication

Secondary Outcome Measures

Hamilton Depression Rating Scale, Positive and Negative Symptom Scale and Clinical Global Impression scale at baseline and then weekly through the end of the trial

Full Information

First Posted
November 9, 2005
Last Updated
November 17, 2005
Sponsor
Bronx VA Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00252044
Brief Title
Pergolide for Cognitive Symptoms in Schizotypal Personality Disorder
Official Title
The Dopaminergic System in Schizotypal Personality Disorder: Pergolide for Cognitive Symptoms in Schizotypal Personality Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
November 2005
Overall Recruitment Status
Unknown status
Study Start Date
October 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Bronx VA Medical Center

4. Oversight

5. Study Description

Brief Summary
Hypothesis: Schizotypal personality disorder patients will show cognitive improvements in 1) working memory 2) learning and memory 3) sustained attention 4) enhanced performance on the AX-CPT, N-back and Eriksen during pergolide treatment. There will be a significant diagnosis by drug administration of 0.3 mg of oral pergolide interaction for performance on the cognitive tasks, with the schizotypal personality disorder group demonstrating significantly improved peformance compared to the other personality disorder group after pergolide compared with placebo. Design: Randomized, double-blind, crossover study of pergolide vs. placebo. Half of subjects receive pergolide for eight weeks; half of subjects receive placebo for four weeks followed by pergolide for four weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizotypal Personality Disorder, Other Personality Disorders

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Pergolide
Primary Outcome Measure Information:
Title
Performance on tests of sustained attention, episodic memory and working memory at baseline and after 2, 4, 6 and 8 weeks on the study medication
Secondary Outcome Measure Information:
Title
Hamilton Depression Rating Scale, Positive and Negative Symptom Scale and Clinical Global Impression scale at baseline and then weekly through the end of the trial

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: DSM-IV criteria for Schizotypal Personality Disorder (or meets full criteria bar one) or another personality disorder and shows impairment on markers of cognitive functioning. Medically healthy, not abusing drugs or alcohol, is at least two weeks medication-free and does not have significant neurological disease. - Exclusion Criteria: DSM-IV or RDC criteria for Schizophrenia or any Schizophrenia-related psychotic disorder or for Bipolar Disorder. Any other Axis I disorders must be transient and preceded by the personality disorder diagnosis, which should be primarily responsible for subject's functional impairment. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emily Hart
Phone
212-241-0441
Email
mpgroup@mssm.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Larry J Siever, MD
Organizational Affiliation
Bronx VA Medical Center/Mount Sinai School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

Pergolide for Cognitive Symptoms in Schizotypal Personality Disorder

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