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

NCT01466205 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2012-07-20

No results posted yet for this study

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.

Conditions

  • Cognitive Impairments
  • Schizotypal Personality Disorder

Interventions

DRUG

DAR-0100A

DAR-0100A will be administered intravenously in a dose of 15mg in 150mls of saline over 30 minutes at approximately 11:00AM on each of three consecutive days of administration. Additional saline will be co-administered to ensure hydration.

DRUG

Placebo

150mls of saline is administered over 30 minutes at approximately 11:00AM on each of three consecutive days of administration. Additional saline will be co-administered to ensure hydration.

Sponsors & Collaborators

  • New York State Psychiatric Institute

    collaborator OTHER

  • Larry J. Siever

    lead OTHER

Principal Investigators

  • Larry J Siever, MD · Icahn School of Medicine at Mount Sinai

  • Larry Siever, MD · James J Peters Bronx VA Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01466205 on ClinicalTrials.gov