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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01MH097799-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| New York State Psychiatric Institute | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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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.
Primary Aims:
Secondary Aims:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DAR 0-100A then Placebo | Experimental | 15 mg is dissolved in 150 cc NS administered over 30 minutes x 3 consecutive days. 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). |
|
| Placebo then DAR 0-100A | Placebo Comparator | 15 mg dissolved in 150 cc NS saline is administered over 30 minutes x 3 consecutive days. 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). |
|
| Healthy Control | No Intervention | patients without diagnosis of SPD |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DAR 0-100A | Drug | 15 mg DAR 0100A is dissolved in 150 cc NS administered over 30 minutes intravenously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Modified AX-CPT (d') | A cognitive test of working memory | Baseline performance |
| Measure | Description | Time Frame |
|---|---|---|
| The Modified AX-CPT (d') | A cognitive test of working memory | Day one |
| The Modified AX-CPT (d') | A cognitive test of working memory | Day three |
| Measure | Description | Time Frame |
|---|---|---|
| the N-Back | A cognitive tests of working memory - the N-Back (% correct at the 2-back condition) | Baseline |
| the N-Back | A cognitive tests of working memory - the N-Back (% correct at the 2-back condition) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonia S. New, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7862943 | Background | Arnsten AF, Cai JX, Murphy BL, Goldman-Rakic PS. Dopamine D1 receptor mechanisms in the cognitive performance of young adult and aged monkeys. Psychopharmacology (Berl). 1994 Oct;116(2):143-51. doi: 10.1007/BF02245056. | |
| 16946930 | Background | Abi-Dargham A. Probing cortical dopamine function in schizophrenia: what can D1 receptors tell us? World Psychiatry. 2003 Oct;2(3):166-71. |
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| ID | Term |
|---|---|
| D012569 | Schizotypal Personality Disorder |
| D060825 | Cognitive Dysfunction |
| D003072 | Cognition Disorders |
| D010554 | Personality Disorders |
| D003693 | Delirium |
| D003704 | Dementia |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D019965 | Neurocognitive Disorders |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| C061532 | dihydrexidine |
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|
| Placebo | Drug | 15 mg DAR placebo is dissolved in 150 cc NS administered over 30 minutes intravenously. |
|
| The Modified AX-CPT (d') | A cognitive test of working memory | One month |
| Day one |
| the N-Back | A cognitive tests of working memory - the N-Back (% correct at the 2-back condition) | Day three |
| the N-Back | A cognitive tests of working memory - the N-Back (% correct at the 2-back condition) | One month |
| the DOT Task | A cognitive tests of working memory - the DOT Task (distance error at 30 second delay--no delay) | Baseline |
| the DOT Task | A cognitive tests of working memory - the DOT Task (distance error at 30 second delay--no delay) | Day one |
| the DOT Task | A cognitive tests of working memory - the DOT Task (distance error at 30 second delay--no delay) | Day three |
| the DOT Task | A cognitive tests of working memory - the DOT Task (distance error at 30 second delay--no delay) | One month |
| the Paced Auditory Serial Addition Task (PASAT) | A cognitive tests of working memory - the Paced Auditory Serial Addition Task | Baseline |
| the Paced Auditory Serial Addition Task (PASAT) | A cognitive tests of working memory - the Paced Auditory Serial Addition Task | Day one |
| the Paced Auditory Serial Addition Task (PASAT) | A cognitive tests of working memory - the Paced Auditory Serial Addition Task | Day three |
| the Paced Auditory Serial Addition Task (PASAT) | A cognitive tests of working memory - the Paced Auditory Serial Addition Task | One month |
| 10720329 | Background | Castner SA, Williams GV, Goldman-Rakic PS. Reversal of antipsychotic-induced working memory deficits by short-term dopamine D1 receptor stimulation. Science. 2000 Mar 17;287(5460):2020-2. doi: 10.1126/science.287.5460.2020. |
| 9126882 | Background | Fici GJ, Wu H, VonVoigtlander PF, Sethy VH. D1 dopamine receptor activity of anti-parkinsonian drugs. Life Sci. 1997;60(18):1597-603. doi: 10.1016/s0024-3205(97)00126-4. |
| 10633486 | Background | Kirrane RM, Mitropoulou V, Nunn M, New AS, Harvey PD, Schopick F, Silverman J, Siever LJ. Effects of amphetamine on visuospatial working memory performance in schizophrenia spectrum personality disorder. Neuropsychopharmacology. 2000 Jan;22(1):14-8. doi: 10.1016/S0893-133X(99)00075-5. |
| 12823075 | Background | Koenigsberg HW, Reynolds D, Goodman M, New AS, Mitropoulou V, Trestman RL, Silverman J, Siever LJ. Risperidone in the treatment of schizotypal personality disorder. J Clin Psychiatry. 2003 Jun;64(6):628-34. doi: 10.4088/jcp.v64n0602. |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |