Pergolide for Cognitive Symptoms in Schizotypal Personality Disorder

November 17, 2005 updated by: Bronx VA Medical Center

The Dopaminergic System in Schizotypal Personality Disorder: Pergolide for Cognitive Symptoms in Schizotypal Personality Disorder

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • Recruiting
        • Mount Sinai School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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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.

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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bronx VA Medical Center

Investigators

  • Principal Investigator: Larry J Siever, MD, Bronx VA Medical Center/Mount Sinai School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2000

Study Registration Dates

First Submitted

November 9, 2005

First Submitted That Met QC Criteria

November 9, 2005

First Posted (Estimate)

November 11, 2005

Study Record Updates

Last Update Posted (Estimate)

November 21, 2005

Last Update Submitted That Met QC Criteria

November 17, 2005

Last Verified

November 1, 2005

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7609-028

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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