Schizotypal Personality Disorder Clinical Trial
Official title:
A D1 Agonist For Working Memory Enhancement In The Schizophrenia Spectrum
Verified date | April 2018 |
Source | Icahn School of Medicine at Mount Sinai |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 120 |
Est. completion date | January 12, 2018 |
Est. primary completion date | January 12, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Icahn School of Medicine at Mount Sinai | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Antonia New | National Institute of Mental Health (NIMH), New York State Psychiatric Institute |
United States,
Abi-Dargham A. Probing cortical dopamine function in schizophrenia: what can D1 receptors tell us? World Psychiatry. 2003 Oct;2(3):166-71. — View Citation
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. — View Citation
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. — View Citation
Fici GJ, Wu H, VonVoigtlander PF, Sethy VH. D1 dopamine receptor activity of anti-parkinsonian drugs. Life Sci. 1997;60(18):1597-603. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | the N-Back | A cognitive tests of working memory - the N-Back (% correct at the 2-back condition) | Baseline | |
Other | the N-Back | A cognitive tests of working memory - the N-Back (% correct at the 2-back condition) | Day one | |
Other | the N-Back | A cognitive tests of working memory - the N-Back (% correct at the 2-back condition) | Day three | |
Other | the N-Back | A cognitive tests of working memory - the N-Back (% correct at the 2-back condition) | One month | |
Other | the DOT Task | A cognitive tests of working memory - the DOT Task (distance error at 30 second delay--no delay) | Baseline | |
Other | the DOT Task | A cognitive tests of working memory - the DOT Task (distance error at 30 second delay--no delay) | Day one | |
Other | the DOT Task | A cognitive tests of working memory - the DOT Task (distance error at 30 second delay--no delay) | Day three | |
Other | the DOT Task | A cognitive tests of working memory - the DOT Task (distance error at 30 second delay--no delay) | One month | |
Other | the Paced Auditory Serial Addition Task (PASAT) | A cognitive tests of working memory - the Paced Auditory Serial Addition Task | Baseline | |
Other | the Paced Auditory Serial Addition Task (PASAT) | A cognitive tests of working memory - the Paced Auditory Serial Addition Task | Day one | |
Other | the Paced Auditory Serial Addition Task (PASAT) | A cognitive tests of working memory - the Paced Auditory Serial Addition Task | Day three | |
Other | the Paced Auditory Serial Addition Task (PASAT) | A cognitive tests of working memory - the Paced Auditory Serial Addition Task | One month | |
Primary | The Modified AX-CPT (d') | A cognitive test of working memory | Baseline performance | |
Secondary | The Modified AX-CPT (d') | A cognitive test of working memory | Day one | |
Secondary | The Modified AX-CPT (d') | A cognitive test of working memory | Day three | |
Secondary | The Modified AX-CPT (d') | A cognitive test of working memory | One month |
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