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CRT-Guanfacine for SPD

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ClinicalTrials.gov Identifier: NCT02524899
Recruitment Status : Completed
First Posted : August 17, 2015
Last Update Posted : February 28, 2017
Sponsor:
Collaborator:
Brain & Behavior Research Foundation
Information provided by (Responsible Party):
Margaret McNamara McClure, Icahn School of Medicine at Mount Sinai

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.

Condition or disease Intervention/treatment Phase
Schizotypal Personality Disorder SPD Behavioral: Cognitive Remediation Therapy Drug: Guanfacine Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Guanfacine Enhancement of Working Memory: Prospects for Augmenting Cognitive Remediation in the Schizophrenia Spectrum
Study Start Date : January 2014
Actual Primary Completion Date : January 10, 2017
Actual Study Completion Date : January 10, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Cognitive Remediation Therapy and placebo
7.5 weeks of twice weekly cognitive remediation sessions
Behavioral: Cognitive Remediation Therapy
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.
Other Name: CRT

Drug: Placebo
After completing baseline cognitive testing, subjects will be randomized to guanfacine or placebo. Subjects in placebo arm will have matching schedule as active arm.

Experimental: Guanfacine and CRT
7.5 weeks of twice weekly cognitive remediation sessions with 8 weeks of guanfacine
Behavioral: Cognitive Remediation Therapy
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.
Other Name: CRT

Drug: Guanfacine
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Willing and having capacity to provide informed consent
  • Currently meeting DSM-IV-TR criteria for Schizotypal Personality Disorder
  • Males and females between the ages of 18-65
  • Medically healthy: no major or partially treated medical condition that, based on the judgment of the clinician, would either put the patient at increased risk and/or affect our findings.
  • Neurologically healthy: no brain injury or head trauma associated with loss of consciousness, seizures, or other conditions that may have caused functional impairment.
  • At least two weeks free of medication while participating in this study
  • Score at least one standard deviation below normative means on at least one test in the cognitive battery.
  • At least 2 weeks free of psychotropic medication while participating in this study. Medication such as NSAIDS (e.g. Advil), Tylenol, Levothyroxine (if on stable dose 1 month, no symptoms of hypothyroidism and normal thyroid labs), non-centrally acting antihistamines, H2 blockers (e.g. Zantac), PPIs (e.g. Prilosec, Prevacid), and others that do not impact cognitive functioning will be allowed; the study physician will evaluate any medication at the time of the medical clearance on a case by case basis.

Exclusion Criteria:

  • Meet criteria for bipolar I disorder, schizophrenia, schizoaffective disorder, or any other psychotic disorder Clinically significant cardiovascular or neurological conditions, uncontrolled hypertension, clinically significant EKG abnormalities, or serious general medial illness
  • Current substance abuse or have met criteria for substance dependence within the last 6 months (excluding nicotine)
  • Currently meeting DSM-IV-TR criteria for Major Depressive Disorder, not better accounted for and secondary to a personality disorder
  • Currently taking psychotropic medications
  • Currently taking any medications (systemic or otherwise) that the study physician determines could interfere with the study medication and put the participant at risk and/or interfere with the data
  • Currently pregnant or lactating
  • Non-English speaking

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02524899


Locations
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United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Brain & Behavior Research Foundation
Investigators
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Principal Investigator: Margaret McNamara McClure, Ph.D. Icahn School of Medicine at Mount Sinai

Publications:
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Responsible Party: Margaret McNamara McClure, Assistant Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02524899     History of Changes
Other Study ID Numbers: GCO 13-0109
First Posted: August 17, 2015    Key Record Dates
Last Update Posted: February 28, 2017
Last Verified: February 2017

Keywords provided by Margaret McNamara McClure, Icahn School of Medicine at Mount Sinai:
Schizotypal Personality Disorder
SPD
cognitive remediation therapy
CRT
guanfacine
cognitive impairment
working memory
pharmacological cognitive enhancing agent
neuropsychological testing
schizophrenia spectrum disorders
Personality Disorders

Additional relevant MeSH terms:
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Personality Disorders
Schizotypal Personality Disorder
Mental Disorders
Guanfacine
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs