Ignite Creation Date:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2026-03-07 @ 4:27 PM
Study NCT ID:
NCT02507206
Status:
COMPLETED
Last Update Posted:
2018-04-09
First Post:
2015-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A D1 Agonist For Working Memory
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012569', 'term': 'Schizotypal Personality Disorder'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D010554', 'term': 'Personality Disorders'}, {'id': 'D003693', 'term': 'Delirium'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001523', 'term': 'Mental Disorders'}], 'ancestors': [{'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C061532', 'term': 'dihydrexidine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-01-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-05', 'studyFirstSubmitDate': '2015-07-22', 'studyFirstSubmitQcDate': '2015-07-22', 'lastUpdatePostDateStruct': {'date': '2018-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'the N-Back', 'timeFrame': 'Baseline', 'description': 'A cognitive tests of working memory - the N-Back (% correct at the 2-back condition)'}, {'measure': 'the N-Back', 'timeFrame': 'Day one', 'description': 'A cognitive tests of working memory - the N-Back (% correct at the 2-back condition)'}, {'measure': 'the N-Back', 'timeFrame': 'Day three', 'description': 'A cognitive tests of working memory - the N-Back (% correct at the 2-back condition)'}, {'measure': 'the N-Back', 'timeFrame': 'One month', 'description': 'A cognitive tests of working memory - the N-Back (% correct at the 2-back condition)'}, {'measure': 'the DOT Task', 'timeFrame': 'Baseline', 'description': 'A cognitive tests of working memory - the DOT Task (distance error at 30 second delay--no delay)'}, {'measure': 'the DOT Task', 'timeFrame': 'Day one', 'description': 'A cognitive tests of working memory - the DOT Task (distance error at 30 second delay--no delay)'}, {'measure': 'the DOT Task', 'timeFrame': 'Day three', 'description': 'A cognitive tests of working memory - the DOT Task (distance error at 30 second delay--no delay)'}, {'measure': 'the DOT Task', 'timeFrame': 'One month', 'description': 'A cognitive tests of working memory - the DOT Task (distance error at 30 second delay--no delay)'}, {'measure': 'the Paced Auditory Serial Addition Task (PASAT)', 'timeFrame': 'Baseline', 'description': 'A cognitive tests of working memory - the Paced Auditory Serial Addition Task'}, {'measure': 'the Paced Auditory Serial Addition Task (PASAT)', 'timeFrame': 'Day one', 'description': 'A cognitive tests of working memory - the Paced Auditory Serial Addition Task'}, {'measure': 'the Paced Auditory Serial Addition Task (PASAT)', 'timeFrame': 'Day three', 'description': 'A cognitive tests of working memory - the Paced Auditory Serial Addition Task'}, {'measure': 'the Paced Auditory Serial Addition Task (PASAT)', 'timeFrame': 'One month', 'description': 'A cognitive tests of working memory - the Paced Auditory Serial Addition Task'}], 'primaryOutcomes': [{'measure': "The Modified AX-CPT (d')", 'timeFrame': 'Baseline performance', 'description': 'A cognitive test of working memory'}], 'secondaryOutcomes': [{'measure': "The Modified AX-CPT (d')", 'timeFrame': 'Day one', 'description': 'A cognitive test of working memory'}, {'measure': "The Modified AX-CPT (d')", 'timeFrame': 'Day three', 'description': 'A cognitive test of working memory'}, {'measure': "The Modified AX-CPT (d')", 'timeFrame': 'One month', 'description': 'A cognitive test of working memory'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['schizotypal personality disorder', 'cognitive impairment', 'working memory', 'Dopamine Agonists', 'Cognition Disorders', 'Personality Disorders', 'Delirium', 'Dementia', 'Amnestic', 'Cognitive Disorders', 'Mental Disorders', 'Dihydrexidine', 'Dopamine A'], 'conditions': ['Schizotypal Personality Disorder', 'SPD']}, 'referencesModule': {'references': [{'pmid': '7862943', 'type': 'BACKGROUND', '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. doi: 10.1007/BF02245056.'}, {'pmid': '16946930', 'type': 'BACKGROUND', 'citation': 'Abi-Dargham A. Probing cortical dopamine function in schizophrenia: what can D1 receptors tell us? World Psychiatry. 2003 Oct;2(3):166-71.'}, {'pmid': '10720329', 'type': 'BACKGROUND', '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. doi: 10.1126/science.287.5460.2020.'}, {'pmid': '9126882', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '10633486', 'type': 'BACKGROUND', '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. doi: 10.1016/S0893-133X(99)00075-5.'}, {'pmid': '12823075', 'type': 'BACKGROUND', '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. doi: 10.4088/jcp.v64n0602.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nMany 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.", 'detailedDescription': 'Primary Aims:\n\n1. 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.\n2. To compare changes on the primary outcome measures from baseline to Visit 4 testing between drug and placebo administration in SPD subjects.\n3. To compare primary outcome variables from baseline to Visit 4 between patients groups and healthy controls.\n4. To obtain plasma DAR-0100A concentrations on Visit 4 to evaluate plasma concentrations in relation to cognitive changes as a potential covariate.\n\nSecondary Aims:\n\n1. To evaluate the change between baseline and Visit 4 cognitive testing in all SPD patients receiving drug in the first or second phase.\n2. To evaluate secondary outcome and comparison variables between SPD patients on placebo and drug.\n\nPrimary Hypotheses:\n\n1\\. 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.\n\n3\\. 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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Currently meeting DSM-IV-TR criteria for Schizotypal\n* Personality Disorder\n* Males and Females 18 ≤ age ≤ 65\n* Medically and neurologically healthy\n* Willing and having capacity to provide informed consent\n\nExclusion Criteria:\n\n* Currently bipolar I disorder, schizophrenia or current psychosis\n* Clinically significant cardiovascular or neurological conditions, uncontrolled hypertension, clinically significant EKG abnormalities, or serious general medical illness\n* Clinical evidence of dehydration or significant hypotension\n* Currently meeting DSM-IV-TR criteria for Major Depressive Disorder\n* Current substance abuse or past dependence within the last six months (other than nicotine)\n* Currently taking psychotropic medications\n* Currently pregnant or lactating\n* Non-English speaking\n* Socio-economically disadvantaged people will be included in our research study.'}, 'identificationModule': {'nctId': 'NCT02507206', 'briefTitle': 'A D1 Agonist For Working Memory', 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'A D1 Agonist For Working Memory Enhancement In The Schizophrenia Spectrum', 'orgStudyIdInfo': {'id': 'GCO 11-1279'}, 'secondaryIdInfos': [{'id': '5R01MH097799-02', 'link': 'https://reporter.nih.gov/quickSearch/5R01MH097799-02', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DAR 0-100A then Placebo', 'description': '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).', 'interventionNames': ['Drug: DAR 0-100A', 'Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo then DAR 0-100A', 'description': '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).', 'interventionNames': ['Drug: DAR 0-100A', 'Drug: Placebo']}, {'type': 'NO_INTERVENTION', 'label': 'Healthy Control', 'description': 'patients without diagnosis of SPD'}], 'interventions': [{'name': 'DAR 0-100A', 'type': 'DRUG', 'otherNames': ['DHX', 'dihydrexidine'], 'description': '15 mg DAR 0100A is dissolved in 150 cc NS administered over 30 minutes intravenously.', 'armGroupLabels': ['DAR 0-100A then Placebo', 'Placebo then DAR 0-100A']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '15 mg DAR placebo is dissolved in 150 cc NS administered over 30 minutes intravenously.', 'armGroupLabels': ['DAR 0-100A then Placebo', 'Placebo then DAR 0-100A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Antonia S. New, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Antonia New', 'class': 'OTHER'}, 'collaborators': [{'name': 'New York State Psychiatric Institute', 'class': 'OTHER'}, {'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of Psychiatry and Director of Medical Student Education', 'investigatorFullName': 'Antonia New', 'investigatorAffiliation': 'Icahn School of Medicine at Mount Sinai'}}}}