Guanfacine for Improving Cognitive Symptoms in People With Schizotypal Personality Disorder - Tabular View

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Guanfacine for Improving Cognitive Symptoms in People With Schizotypal Personality Disorder

This study is currently recruiting participants.
Information provided by National Institute of Mental Health (NIMH)

This Tabular View shows the required WHO registration data elements as marked by ^†

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.

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.

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 ]

Condition ^†

Schizotypal Personality Disorder
Personality Disorders

Intervention ^†

Drug: Guanfacine
Drug: Placebo

MEDLINE PMIDs

Links

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

Recruitment Information Fields

Recruitment Status ^†

Recruiting

Enrollment ^†

180

Start Date ^†

September 2007

Completion Date

Eligibility 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

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Contact: Jessica DeVito, BS

212-241-9775

jessica.devito@mssm.edu

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 ^†

Principal Investigator:

Larry J. Siever, MD

Bronx VA Medical Center/Mount Sinai School of Medicine

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

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.