Overview

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