Recruiting
Phase 2

D1 Agonist

Sponsor:

Larry J. Siever

Code:

NCT01466205

Conditions

Cognitive Impairments

Schizotypal Personality Disorder

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

DAR-0100A

Placebo

Study Details

Brief 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

Study ID

NCT01466205

Start date

Jan, 2011

Status verified date

Jul, 2012

Completion date

Jan, 2013

Anticipated

Primary completion date

Jan, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: DAR 0-100A

The examination of SPD subjects, who are more likely than schizophrenia patients to show significant cognitive improvement after the use of single doses of dopamine agonists, such as DAR-0100A provides an excellent opportunity to demonstrate the effectiveness of D1 agonists on cognition in the schizophrenia spectrum.

placebo comparator: Placebo

Some subjects receive placebo, instead of the study drug, in a double-blind randomized fashion. This allows for performance comparison between SPD subjects on DAR-0100A and those on placebo. The hypothesis is that SPD subjects on DAR-100A will show improvement on primary measures greater than SPD subjects randomized to placebo between baseline and post-drug.

Interventions

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.

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.

Primary outcome measure

  • Efficacy of a D1 Agonist for Cognitive Enhancement of Working Memory in Schizotypal Personality Disorder [ Time Frame: Baseline performance ]
  • Efficacy of a D1 Agonist for Cognitive Enhancement of Working Memory in Schizotypal Personality Disorder [ Time Frame: day one of drug administration ]
  • Efficacy of a D1 Agonist for Cognitive Enhancement of Working Memory in Schizotypal Personality Disorder [ Time Frame: after three days of drug administration ]
  • Efficacy of a D1 Agonist for Cognitive Enhancement of Working Memory in Schizotypal Personality Disorder [ Time Frame: one month after drug administration ]

Central Contacts and Locations

Central contacts

Lauren C Zaluda, BA

2122410441lauren.zaluda@mssm.edu

Yosefa A Ehrlich, BA

2122412190yosefa.ehrlich@mssm.edu

Locations

Mount Sinai School of Medicine

Recruiting

New York, New York, United States, 10029

Principal Investigator:

Larry J Siever, MD

More Information

Sponsor

Larry J. Siever

Last update posted

Jul 20, 2012

Last verified

Jul, 2012

Keywords

  • schizotypal personality disorder
  • cognitive impairment
  • working memory

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Larry J. Siever on 2012-07-20.