Clinical Trial: CRT-Guanfacine for SPD

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Guanfacine Enhancement of Working Memory: Prospects for Augmenting Cognitive Remediation in the Schizophrenia Spectrum

Brief Summary: This is a study to assess the efficacy augmenting cognitive remediation therapy (CRT) with a pharmacological agent for individuals with schizotypal personality disorder (SPD). Impaired cognition, along with functional and social skill deficits, is a core feature of schizophrenia and schizophrenia spectrum disorders. A better understanding of the cognitive and functional impairments in schizophrenia-related conditions, as well as the identification of interventions that can reduce these impairments, are vital to improving outcomes for individual with these disorders.

Detailed Summary:

This study proposes to 1) evaluate the effects of 7.5 weeks of twice weekly cognitive remediation sessions, combined with concurrent administration of 8 weeks of guanfacine/placebo, on performance on cognitive, functional, and social skills performance measures in a sample of SPD patients with proven deficits in these areas. 2) Compare the effect of cognitive remediation therapy + 8 weeks guanfacine with cognitive remediation therapy + placebo on cognition in this schizophrenia spectrum disorder population. 3) Further characterize cognitive impairment in SPD using specific tests of working memory to evaluate the relationship between working memory and functional and social skill outcomes in this population.

The study hypothesizes that:

  1. While both groups (those receiving CRT + guanfacine or CRT +placebo) will demonstrate improvements in overall cognitive functioning, SPD participants receiving CRT + guanfacine will evidence greater increases in post-treatment performance on our primary outcome measures—MATRICS battery total score, AX-CPT, N-Back, PASAT and DOT Test— particularly in areas related to working memory.
  2. Participants receiving CRT + guanfacine will also demonstrate greater improvements in functional and social functioning exploratory measures, as evidenced by performance on our secondary assessments, the UPSA, SSPA, MASC, and Reading of the Mind in the Eyes.

Sponsor: Icahn School of Medicine at Mount Sinai

Current Primary Outcome: MATRICS Consensus Cognitive Battery Score [ Time Frame: Baseline and 7.5 weeks after randomization ]

Change in score at 7.5 weeks as compared to baseline. MATRICS Consensus Cognitive Battery: Subjects will complete the following MATRICS cognitive assessments. The dependent variable (DV) is the total MATRICS battery score. Trail Making Test (TMT): Part A Brief Assessment of Cognition in Schizophrenia: Symbol Coding (BACS SC) Hopkins Verbal Learning Test—Revised (HVLT-R) Weschler Memory Scale-III: Spatial Span Letter Number Span (LNS) Neuropsychological Assessment Battery (NAB): Mazes Brief Visuospatial Memory Test—Revised (BVMT-R) Category Fluency: Animal Naming


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Modified version of AX-Continuous Performance Test (AX-CPT) Score [ Time Frame: Baseline and 7.5 weeks after randomization ]
    Change in score at 7.5 weeks as compared to baseline. This modified AX-CPT assesses context processing, a domain that has been shown to be impaired in both schizophrenia and SPD.
  • UCSD Performance Based Skills Assessment (UPSA) Score [ Time Frame: Baseline and 7.5 weeks after randomization ]
    Change in score at 7.5 weeks as compared to baseline. The UPSA is an office based test to measure competence at performing day-to-day tasks in five domains: household chores, communication, finance, transportation, and planning recreational activities.
  • Social Skills Performance Assessment (SSPA) Score [ Time Frame: Baseline and 7.5 weeks after randomization ]
    Change in score at 7.5 weeks as compared to baseline. The SSPA is an office based test designed to measure social competence.
  • Reading of the Mind in the Eyes Score [ Time Frame: Baseline and 7.5 weeks after randomization ]
    Change in score at 7.5 weeks as compared to baseline. This is a measure of adult "mentalising", the ability to attribute mental states to oneself or another person.


Original Secondary Outcome: Same as current

Information By: Icahn School of Medicine at Mount Sinai

Dates:
Date Received: August 10, 2015
Date Started: January 2014
Date Completion:
Last Updated: February 24, 2017
Last Verified: February 2017