Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Guanfacine for Improving Cognitive Symptoms in People With Schizotypal Personality Disorder
This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), May 2008
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00353379
  Purpose

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


Condition Intervention Phase
Schizotypal Personality Disorder
Personality Disorders
Drug: Guanfacine
Drug: Placebo
Phase IV

MedlinePlus related topics: Personality Disorders
Drug Information available for: Guanfacine Guanfacine hydrochloride
U.S. FDA Resources
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

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Performance on tests of sustained attention, episodic memory, and working memory [ Time Frame: Measured at Week 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00353379

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

Locations
United States, New York
Mount Sinai School of Medicine Recruiting
New York, New York, United States, 10029
Sponsors and Collaborators
Investigators
Principal Investigator: Larry J. Siever, MD Bronx VA Medical Center/Mount Sinai School of Medicine
  More Information

Website for the Special Evaluation Program for Mood and Personality Disorders  This link exits the ClinicalTrials.gov site

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

Study placed in the following topic categories:
Signs and Symptoms
Guanfacine
Mental Disorders
Schizotypal Personality Disorder
Neurologic Manifestations
Neurobehavioral Manifestations
Personality Disorders

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 30, 2009