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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00353379 |
This study will determine the effectiveness of guanfacine in improving symptoms of schizotypal personality disorder.
Condition | Intervention | Phase |
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Schizotypal Personality Disorder Personality Disorders |
Drug: Guanfacine Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | Pharmacology of Cognition in Schizotypal Personality Disorder: Guanfacine for Cognitive Symptoms in Schizotypal Personality Disorder |
Estimated Enrollment: | 180 |
Study Start Date: | September 2007 |
Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Participants will take guanfacine.
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Drug: Guanfacine
Participants will take guanfacine for 6 weeks. Guanfacine dosages will not exceed 2 mg per day.
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2: Placebo Comparator
Participants will take placebo.
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Drug: Placebo
Participants will take placebo for 6 weeks.
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Schizotypal personality disorder is a psychiatric condition that is characterized by deficiencies in interpersonal relationships and disturbances in thought patterns, appearance, and behavior. This disorder is different from schizophrenia. While some of the symptoms of the two disorders are similar, such as the tendency to have unusual beliefs and behaviors, people with schizotypal personality disorder do not experience hallucinations and are not significantly disconnected from reality, both of which are signature symptoms of schizophrenia. Guanfacine is a drug that is often used to treat high blood pressure and attention deficit hyperactivity disorder. There is evidence that guanfacine enhances cognition and diminishes impulsivity. This study will determine the effectiveness of guanfacine in improving symptoms of schizotypal personality disorder.
Participants in this 6-week, double-blind study will be randomly assigned to receive either guanfacine or placebo. Participants receiving guanfacine will remain on the drug for the duration of the study. The other participants will receive placebo for the duration of the study. Guanfacine dosages will not exceed 2 mg per day. All participants will report to the study site weekly for assessments of vital signs, study compliance, medication side effects, and psychological symptoms. Additional cognitive testing will be performed at week 6. Upon study completion, patients will return for a follow-up assessment.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jessica DeVito, BS | 212-241-9775 | jessica.devito@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 |
Responsible Party: | Bronx VA Medical Center/Mount Sinai School of Medicine ( Larry J. Siever ) |
Study ID Numbers: | R01 MH56140, DATR A3-NSS |
Study First Received: | July 14, 2006 |
Last Updated: | May 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00353379 |
Health Authority: | United States: Federal Government |
Signs and Symptoms Guanfacine Mental Disorders Schizotypal Personality Disorder |
Neurologic Manifestations Neurobehavioral Manifestations Personality Disorders |
Neurotransmitter Agents Disease Adrenergic alpha-Agonists Adrenergic Agents Molecular Mechanisms of Pharmacological Action Nervous System Diseases Physiological Effects of Drugs |
Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions Adrenergic Agonists Pathologic Processes Therapeutic Uses |