Clinical Testing of a D1 Agonist for Cognitive Enhancement in Schizotypal Personality Disorder
Status unconfirmed · Phase 2 · Has a placebo group
Conditions studied: Cognitive Impairments, Schizotypal Personality Disorder
In brief
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.
Key facts
- Study ID
- NCT01466205
- Run by
- Larry J. Siever
- People needed
- 20
- Starts
- 2011-01-01
- Expected to finish
- 2013-01-01
- Last updated by the study team
- 2012-07-20
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Mount Sinai School of Medicine — New York, New York, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.