Official Title: “Pharmacology of Cognition in Schizotypal Personality Disorder: Guanfacine for Cognitive Symptoms in Schizotypal Personality Disorder”

This study will determine the effectiveness of guanfacine in improving symptoms of schizotypal personality disorder.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study

Study Primary Completion Date: May 2012

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.

Intervention(s) in this Clinical Trial

• Drug: Guanfacine
  • Participants will take guanfacine for 6 weeks. Guanfacine dosages will not exceed 2 mg per day.
• Drug: Placebo
  • Participants will take placebo for 6 weeks.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Participants will take guanfacine.
• Placebo Comparator: 2
  • Participants will take placebo.

Primary Measures

• Performance on tests of sustained attention, episodic memory, and working memory
  • Time Frame: Measured at Week 6
    Safety Issue?: No

Secondary Measures

• Hamilton Depression Rating Scale
  • Time Frame: Measured at Week 6
    Safety Issue?: No
• Positive and Negative Symptom Scale
  • Time Frame: Measured at Week 6
    Safety Issue?: No
• Clinical Global Impression Scale
  • Time Frame: Measured at Week 6
    Safety Issue?: No

Inclusion Criteria:

• Meets DSM-IV criteria for schizotypal personality disorder (or meets full criteria except for one) OR meets DSM-IV criteria for avoidant personality disorder (without schizotypal, paranoid, and schizoid comorbidities and fewer than two schizotypal criteria) and shows impairment of cognitive functioning according to set markers
• In good psychological health
• Medication-free for at least 2 weeks prior to study entry
• Personality disorder holds primary responsibility for participant's functional impairment (other Axis I disorders will not be criteria for exclusion as long as they are transient and were preceded by the personality disorder diagnosis)
• Control subjects must have no current Axis I or II diagnosis and no family history of psychotic disorders

Exclusion Criteria:

• Meets DSM-IV or RDC criteria for schizophrenia, any schizophrenia-related psychotic disorder, or bipolar disorder
• Significant neurological disease
• Current drug or alcohol abuse or dependence in the last 6 months
• Current major depression
• Vision <20/40, IQ<80, or 20% above ideal weight

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: National Institute of Mental Health (NIMH)

Overall Clinical Trial Officials and Contacts

Larry J. Siever, MD Principal Investigator Bronx VA Medical Center/Mount Sinai School of Medicine  

Overall Contact: Jessica DeVito, BS 212-241-9775 jessica.devito@mssm.edu

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00353379

Study ID Number: R01 MH56140

ClinicalTrials.gov Identifier: NCT00353379

Health Authority: United States: Federal Government

Website for the Special Evaluation Program for Mood and Personality Disorders