Pergolide for Cognitive Symptoms in Schizotypal Personality Disorder
Recruitment status was Recruiting
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Purpose
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 | Intervention |
|---|---|
|
Schizotypal Personality Disorder Other Personality Disorders |
Drug: Pergolide |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Diagnostic |
| Official Title: | The Dopaminergic System in Schizotypal Personality Disorder: Pergolide for Cognitive Symptoms in Schizotypal Personality Disorder |
- 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
- 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
| Study Start Date: | October 2000 |
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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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Contacts and Locations| Contact: Emily Hart | 212-241-0441 | mpgroup@mssm.edu |
| United States, New York | |
| Mount Sinai School of Medicine | Recruiting |
| New York, New York, United States, 10029 | |
| Principal Investigator: | Larry J Siever, MD | Bronx VA Medical Center/Mount Sinai School of Medicine |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00252044 History of Changes |
| Other Study ID Numbers: | 7609-028 |
| Study First Received: | November 9, 2005 |
| Last Updated: | November 17, 2005 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Personality Disorders Schizotypal Personality Disorder Neurobehavioral Manifestations Mental Disorders Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
Pergolide Dopamine Agonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013