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| Descriptive Information Fields | |||||
| Brief Title † | Guanfacine for Improving Cognitive Symptoms in People With Schizotypal Personality Disorder | ||||
| Official Title † | Pharmacology of Cognition in Schizotypal Personality Disorder: Guanfacine for Cognitive Symptoms in Schizotypal Personality Disorder | ||||
| Brief Summary | This study will determine the effectiveness of guanfacine in improving symptoms of schizotypal personality disorder. |
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| Detailed Description | 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. |
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| Study Phase | Phase IV | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | Performance on tests of sustained attention, episodic memory, and working memory [ Time Frame: Measured at Week 6 ] [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | Hamilton Depression Rating Scale [ Time Frame: Measured at Week 6 ] [ Designated as safety issue: No ] Positive and Negative Symptom Scale [ Time Frame: Measured at Week 6 ] [ Designated as safety issue: No ] Clinical Global Impression Scale [ Time Frame: Measured at Week 6 ] [ Designated as safety issue: No ] |
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| Condition † | Schizotypal Personality Disorder Personality Disorders |
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| Intervention † | Drug: Guanfacine Drug: Placebo |
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| MEDLINE PMIDs | |||||
| Links | Website for the Special Evaluation Program for Mood and Personality Disorders ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 180 | ||||
| Start Date † | September 2007 | ||||
| Completion Date | |||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 60 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts †† |
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| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00353379 | ||||
| Organization ID | R01 MH56140 | ||||
| Secondary IDs †† | DATR A3-NSS | ||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||
| Verification Date | May 2008 | ||||
| First Received Date † | July 14, 2006 | ||||
| Last Updated Date | May 13, 2008 | ||||