Clinical Testing of a D1 Agonist for Cognitive Enhancement in Schizotypal Personality Disorder

• Status: Unknown status
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Currently, no study to date has directly tested a selective D1R agonist in relation to the cognitive impairment of Schizophrenia without the confound of neuroleptics. The investigators propose to examine the efficacy of DAR-0100A, a highly selective, full D1R agonist supported by pre-clinical and preliminary pilot clinical data, in ameliorating the cognitive deficits in Schizotypal Personality Disordered subjects receiving no medications including antipsychotics.

The investigators hypothesize that 1) Baseline primary outcome measures will be impaired in Schizotypal personality disorder (SPD) subjects compared to controls, 2) SPD subjects on DAR-0100A will show improvement on primary measures greater than healthy controls and SPD patients randomized to placebo, and 3) SPD patients will show significant improvements on primary outcome variables on drug compared to placebo.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Larry J. Siever
• Collaborator: New York State Psychiatric Institute
• Treatments: Dihydrexidine

Criteria

Inclusion Criteria:

• Currently meeting DSM-IV-TR criteria for Schizotypal Personality Disorder

• Males and Females 18 ≤ age ≤ 60

• Medically and neurologically healthy

• Willing and having capacity to provide informed consent

Exclusion Criteria:

• Currently bipolar I disorder, schizophrenia or current psychosis

• Clinically significant cardiovascular or neurological conditions, uncontrolled hypertension, clinically significant EKG abnormalities, or serious general medical illness

• Clinical evidence of dehydration or significant hypotension

• Currently meeting DSM-IV-TR criteria for Major Depressive Disorder

• Current substance abuse or past dependence within the last six months (other than nicotine)

• Currently taking psychotropic medications

• Currently pregnant or lactating

• Non-English speaking

Socio-economically disadvantaged people will be included in our research study.