CRT-Guanfacine for SPD
Condition: Schizotypal Personality Disorder; SPD
MeSH terms: Personality Disorders; Schizotypal Personality Disorder
Study type: Interventional
Phase: Phase 2

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 description: 
      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.
    

Intervention name(s): Cognitive Remediation Therapy; Guanfacine; Placebo
Intervention type(s): Behavioral; Drug; Drug
Intervention description(s): Cognitive Remediation Therapy (CRT) will consist of fifteen 45-minute, twice weekly sessions over 7.5 weeks. During each session, subjects, seated at a desk in a private interview room in our research office suite, will work through exercises that are part of the Psychological Software Services CogReHab program. The software to be used is a multimedia, Windows-based program that consists of exercises aimed at improving areas of deficit within the schizophrenia spectrum, such as executive function, working memory, and social cognition.; After completing baseline cognitive testing, subjects will be randomized to guanfacine or placebo. Subjects in the active treatment arm will begin with a guanfacine dose of 0.5mg/day and be titrated up to a maximum of 2mg/day according to our well-tolerated protocol in schizophrenia subjects. The dosing schedule of active guanfacine will be as follows: 0.5mg/d for week 1, 1.0mg/d for week 2, 1.0 mg bid for weeks 3, 4, 5, 6, and 7 and 1.0mg/d for week 8.; After completing baseline cognitive testing, subjects will be randomized to guanfacine or placebo. Subjects in placebo arm will have matching schedule as active arm.
Other intervention name(s): CRT
Intervention MeSH terms: Guanfacine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Schizotypal Personality Disorder; SPD; cognitive remediation therapy; CRT; guanfacine; cognitive impairment; working memory; pharmacological cognitive enhancing agent; neuropsychological testing; schizophrenia spectrum disorders; Personality Disorders