Clinical Trial: Pharmacology of Cognition in Schizotypal Personality Disorder

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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 cognitive and functional impairments in schizotypal personality disorder.

Detailed Summary:

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.


Sponsor: Icahn School of Medicine at Mount Sinai

Current Primary Outcome:

  • Performance on tests of sustained attention, episodic memory, and working memory [ Time Frame: Measured at Week 1 ]
  • Performance on tests of sustained attention, episodic memory, and working memory [ Time Frame: Measured at Week 4 ]


Original Primary Outcome: Performance on tests of sustained attention, episodic memory, and working memory (measured at Week 8)

Current Secondary Outcome:

  • Hamilton Depression Rating Scale [ Time Frame: Measured at Week 1 ]
  • Hamilton Depression Rating Scale [ Time Frame: Measured at Week 2 ]
  • Hamilton Depression Rating Scale [ Time Frame: Measured at Week 3 ]
  • Hamilton Depression Rating Scale [ Time Frame: Measured at Week 4 ]
  • Hamilton Depression Rating Scale [ Time Frame: Measured at Week 5 ]
  • Positive and Negative Symptom Scale [ Time Frame: Measured at Week 1 ]
  • Positive and Negative Symptom Scale [ Time Frame: Measured at Week 2 ]
  • Positive and Negative Symptom Scale [ Time Frame: Measured at Week 3 ]
  • Positive and Negative Symptom Scale [ Time Frame: Measured at Week 4 ]
  • Positive and Negative Symptom Scale [ Time Frame: Measured at Week 5 ]
  • Clinical Global Impression Scale [ Time Frame: Measured at Week 1 ]
  • Clinical Global Impression Scale [ Time Frame: Measured at Week 2 ]
  • Clinical Global Impression Scale [ Time Frame: Measured at Week 3 ]
  • Clinical Global Impression Scale [ Time Frame: Measured at Week 4 ]
  • Clinical Global Impression Scale [ Time Frame: Measured at Week 5 ]


Original Secondary Outcome:

  • Hamilton Depression Rating Scale
  • Positive and Negative Symptom Scale
  • Clinical Global Impression Scale (all measured at Week 8)


Information By: Icahn School of Medicine at Mount Sinai

Dates:
Date Received: July 14, 2006
Date Started: September 1995
Date Completion:
Last Updated: February 9, 2017
Last Verified: February 2017