A D1 Agonist For Working Memory
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/17/2018 |
| Start Date: | April 2013 |
| End Date: | January 12, 2018 |
A D1 Agonist For Working Memory Enhancement In The Schizophrenia Spectrum
The purpose of the study is to examine the effects of the administration of a drug called
DAR-0100A on attention and memory in persons with schizotypal personality disorder (SPD).
DAR-0100A has not been FDA approved, however in recent studies has been used to treat
cognitive deficits, meaning problems in the way you organize your thinking, in people
diagnosed with schizophrenia.
Many people who carry a diagnosis of schizotypal personality disorder have trouble with
attention and memory. Increasing the presence of a brain chemical called dopamine has been
found to help people with schizophrenia with their attention and memory problems. This study
will investigate whether the same is true for people with schizotypal personality disorder by
using DAR-0100A, a drug that has been shown to help with the cognitive deficits of people
with Parkinson's disease by increasing dopamine effects. Information collected in this
experiment may lead to a better understanding of the brain mechanisms involved in schizotypal
personality disorder and improve treatments for the psychological problems associated with
this condition.
DAR-0100A on attention and memory in persons with schizotypal personality disorder (SPD).
DAR-0100A has not been FDA approved, however in recent studies has been used to treat
cognitive deficits, meaning problems in the way you organize your thinking, in people
diagnosed with schizophrenia.
Many people who carry a diagnosis of schizotypal personality disorder have trouble with
attention and memory. Increasing the presence of a brain chemical called dopamine has been
found to help people with schizophrenia with their attention and memory problems. This study
will investigate whether the same is true for people with schizotypal personality disorder by
using DAR-0100A, a drug that has been shown to help with the cognitive deficits of people
with Parkinson's disease by increasing dopamine effects. Information collected in this
experiment may lead to a better understanding of the brain mechanisms involved in schizotypal
personality disorder and improve treatments for the psychological problems associated with
this condition.
Primary Aims:
1. To perform a 5-year study in which three consecutive days of DAR-0100A at a dose of 15
mg or placebo are administered intravenously over 30 minutes to 60 patients with SPD
(12/yr) in a between-groups, randomized, double-blind design. Cognitive testing will be
performed at baseline (Visit 1) and on the third day of drug/placebo administration
(Visit 4). Subjects will return a minimum of two weeks later for Visit 5 to receive drug
(if randomized initially to placebo) or placebo (if randomized to drug) in a double
blind fashion in an identical protocol. This allows all patients to receive drug for
Secondary Aim 1 while maintaining the blind. Baseline (Visit 1) and repeat cognitive
testing (Visit 4) is also administered to 60 healthy controls per year (12/yr). The
cognitive tests of working memory serving as primary outcome measures will include the
modified AX-CPT (accuracy scores for AX, AY and BX and ANOVA), the N-back (delta
difference 0-back-2-back), and the Paced Auditory Serial Addition Task (PASAT) (%
correct and ANOVA). Other tests included are tests of working and verbal memory,
executive function, and verbal learning for secondary outcome measures as well as
comparison tests not hypothesized to change with drug.
2. To compare changes on the primary outcome measures from baseline to Visit 4 testing
between drug and placebo administration in SPD subjects.
3. To compare primary outcome variables from baseline to Visit 4 between patients groups
and healthy controls.
4. To obtain plasma DAR-0100A concentrations on Visit 4 to evaluate plasma concentrations
in relation to cognitive changes as a potential covariate.
Secondary Aims:
1. To evaluate the change between baseline and Visit 4 cognitive testing in all SPD
patients receiving drug in the first or second phase.
2. To evaluate secondary outcome and comparison variables between SPD patients on placebo
and drug.
Primary Hypotheses:
1. Baseline primary outcome measures will be impaired in 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 between baseline and Visit 4.
3. SPD patients will show significant improvements on primary outcome variables on drug
compared to placebo but not on comparis-on perceptual (JLOT) and processing speed/attentional
tasks (Trails A).
1. To perform a 5-year study in which three consecutive days of DAR-0100A at a dose of 15
mg or placebo are administered intravenously over 30 minutes to 60 patients with SPD
(12/yr) in a between-groups, randomized, double-blind design. Cognitive testing will be
performed at baseline (Visit 1) and on the third day of drug/placebo administration
(Visit 4). Subjects will return a minimum of two weeks later for Visit 5 to receive drug
(if randomized initially to placebo) or placebo (if randomized to drug) in a double
blind fashion in an identical protocol. This allows all patients to receive drug for
Secondary Aim 1 while maintaining the blind. Baseline (Visit 1) and repeat cognitive
testing (Visit 4) is also administered to 60 healthy controls per year (12/yr). The
cognitive tests of working memory serving as primary outcome measures will include the
modified AX-CPT (accuracy scores for AX, AY and BX and ANOVA), the N-back (delta
difference 0-back-2-back), and the Paced Auditory Serial Addition Task (PASAT) (%
correct and ANOVA). Other tests included are tests of working and verbal memory,
executive function, and verbal learning for secondary outcome measures as well as
comparison tests not hypothesized to change with drug.
2. To compare changes on the primary outcome measures from baseline to Visit 4 testing
between drug and placebo administration in SPD subjects.
3. To compare primary outcome variables from baseline to Visit 4 between patients groups
and healthy controls.
4. To obtain plasma DAR-0100A concentrations on Visit 4 to evaluate plasma concentrations
in relation to cognitive changes as a potential covariate.
Secondary Aims:
1. To evaluate the change between baseline and Visit 4 cognitive testing in all SPD
patients receiving drug in the first or second phase.
2. To evaluate secondary outcome and comparison variables between SPD patients on placebo
and drug.
Primary Hypotheses:
1. Baseline primary outcome measures will be impaired in 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 between baseline and Visit 4.
3. SPD patients will show significant improvements on primary outcome variables on drug
compared to placebo but not on comparis-on perceptual (JLOT) and processing speed/attentional
tasks (Trails A).
Inclusion Criteria:
- Currently meeting DSM-IV-TR criteria for Schizotypal
- Personality Disorder
- Males and Females 18 ≤ age ≤ 65
- 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.
We found this trial at
1
site
1428 Madison Ave
New York, New York 10029
New York, New York 10029
(212) 241-6500
Principal Investigator: Antonia S New, MD
Phone: 212-659-8902
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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