CRT-Guanfacine for SPD

• Status: Completed
• Trial end date: 2017-01-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborator: Brain & Behavior Research Foundation
• Treatments: Guanfacine

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