Cognitive Impairments Clinical Trial
— SPDOfficial title:
Clinical Testing of a D1 Agonist for Cognitive Enhancement in Schizotypal Personality Disorder
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | January 2013 |
Est. primary completion date | January 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Mount Sinai School of Medicine | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Larry J. Siever | New York State Psychiatric Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy of a D1 Agonist for Cognitive Enhancement of Working Memory in Schizotypal Personality Disorder | The cognitive tests of working memory serving as primary outcome measures will include the modified AX-CPT (d'), the N-Back (% correct at the 2-back condition), the DOT Task (distance error at 30 second delay--no delay), and the Paced Auditory Serial Addition Task (PASAT)(correct responses). | Baseline performance | No |
Primary | Efficacy of a D1 Agonist for Cognitive Enhancement of Working Memory in Schizotypal Personality Disorder | The cognitive tests of working memory serving as primary outcome measures will include the modified AX-CPT (d'), the N-Back (% correct at the 2-back condition), the DOT Task (distance error at 30 second delay--no delay), and the Paced Auditory Serial Addition Task (PASAT)(correct responses). | day one of drug administration | No |
Primary | Efficacy of a D1 Agonist for Cognitive Enhancement of Working Memory in Schizotypal Personality Disorder | The cognitive tests of working memory serving as primary outcome measures will include the modified AX-CPT (d'), the N-Back (% correct at the 2-back condition), the DOT Task (distance error at 30 second delay--no delay), and the Paced Auditory Serial Addition Task (PASAT)(correct responses). | after three days of drug administration | No |
Primary | Efficacy of a D1 Agonist for Cognitive Enhancement of Working Memory in Schizotypal Personality Disorder | The cognitive tests of working memory serving as primary outcome measures will include the modified AX-CPT (d'), the N-Back (% correct at the 2-back condition), the DOT Task (distance error at 30 second delay--no delay), and the Paced Auditory Serial Addition Task (PASAT)(correct responses). | one month after drug administration | No |
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