Full Text View
Tabular View
No Study Results Posted
Related Studies
Guanfacine for Improving Cognitive Symptoms in People With Schizotypal Personality Disorder
This study is currently recruiting participants.
Study NCT00353379   Information provided by National Institute of Mental Health (NIMH)
First Received: July 14, 2006   Last Updated: August 21, 2009   History of Changes

July 14, 2006
August 21, 2009
September 2007
May 2012   (final data collection date for 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 ]
Performance on tests of sustained attention, episodic memory, and working memory (measured at Week 8)
Complete list of historical versions of study NCT00353379 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Hamilton Depression Rating Scale
  • Positive and Negative Symptom Scale
  • Clinical Global Impression Scale (all measured at Week 8)
 
Guanfacine for Improving Cognitive Symptoms in People With Schizotypal Personality Disorder
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.

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.

Phase IV
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study
  • Schizotypal Personality Disorder
  • Personality Disorders
  • Drug: Guanfacine
  • Drug: Placebo
  • Experimental: Participants will take guanfacine.
  • Placebo Comparator: Participants will take placebo.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
180
 
May 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
Yes
Contact: Jessica DeVito, BS 212-241-9775 jessica.devito@mssm.edu
United States
 
NCT00353379
Larry J. Siever, Bronx VA Medical Center/Mount Sinai School of Medicine
R01 MH056140, DATR A3-NSS
National Institute of Mental Health (NIMH)
 
Principal Investigator: Larry J. Siever, MD Bronx VA Medical Center/Mount Sinai School of Medicine
National Institute of Mental Health (NIMH)
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP