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Pergolide for Cognitive Symptoms in Schizotypal Personality Disorder

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ClinicalTrials.gov Identifier: NCT00252044
Recruitment Status : Unknown
Verified November 2005 by Bronx VA Medical Center.
Recruitment status was:  Recruiting
First Posted : November 11, 2005
Last Update Posted : November 21, 2005
Sponsor:
Information provided by:
Bronx VA Medical Center

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.


Condition or disease Intervention/treatment Phase
Schizotypal Personality Disorder Other Personality Disorders Drug: Pergolide Not Applicable

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Diagnostic
Official Title: The Dopaminergic System in Schizotypal Personality Disorder: Pergolide for Cognitive Symptoms in Schizotypal Personality Disorder
Study Start Date : October 2000

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Primary Outcome Measures :
  1. 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 :
  1. 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


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00252044


Contacts
Contact: Emily Hart 212-241-0441 mpgroup@mssm.edu

Locations
United States, New York
Mount Sinai School of Medicine Recruiting
New York, New York, United States, 10029
Sponsors and Collaborators
Bronx VA Medical Center
Investigators
Principal Investigator: Larry J Siever, MD Bronx VA Medical Center/Mount Sinai School of Medicine

ClinicalTrials.gov Identifier: NCT00252044     History of Changes
Other Study ID Numbers: 7609-028
First Posted: November 11, 2005    Key Record Dates
Last Update Posted: November 21, 2005
Last Verified: November 2005

Additional relevant MeSH terms:
Disease
Personality Disorders
Neurobehavioral Manifestations
Schizotypal Personality Disorder
Pathologic Processes
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Pergolide
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs