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D1 Agonist

DAR 0-100A for Schizotypal Personality Disorder (SPD Trial)

Phase 2
Waitlist Available
Led By Larry Siever, MD
Research Sponsored by Larry J. Siever
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one month after drug administration
Awards & highlights

SPD Trial 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.

Eligible Conditions
  • Schizotypal Personality Disorder
  • Cognitive Impairment

SPD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one month after drug administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and one month after drug administration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy of a D1 Agonist for Cognitive Enhancement of Working Memory in Schizotypal Personality Disorder

SPD Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: DAR 0-100AExperimental Treatment1 Intervention
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.
Group II: PlaceboPlacebo Group1 Intervention
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.

Find a Location

Who is running the clinical trial?

New York State Psychiatric InstituteOTHER
474 Previous Clinical Trials
153,237 Total Patients Enrolled
1 Trials studying Schizotypal Personality Disorder
120 Patients Enrolled for Schizotypal Personality Disorder
Larry J. SieverLead Sponsor
Larry Siever, MDPrincipal InvestigatorJames J Peters Bronx VA Hospital

Frequently Asked Questions

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~1 spots leftby Apr 2025