Ignite Creation Date:
2025-12-25 @ 4:37 AM
Ignite Modification Date:
2025-12-26 @ 3:39 AM
Study NCT ID:
NCT01185418
Status:
COMPLETED
Last Update Posted:
2010-08-20
First Post:
2010-08-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Negative Symptoms and Cognitive Function After Administration of Antipsychotics in Healthy Volunteer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D018967', 'term': 'Risperidone'}, {'id': 'D000068180', 'term': 'Aripiprazole'}, {'id': 'D006220', 'term': 'Haloperidol'}, {'id': 'D000077582', 'term': 'Amisulpride'}, {'id': 'D007785', 'term': 'Lactose'}], 'ancestors': [{'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D002090', 'term': 'Butyrophenones'}, {'id': 'D007659', 'term': 'Ketones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D004187', 'term': 'Disaccharides'}, {'id': 'D009844', 'term': 'Oligosaccharides'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D000073893', 'term': 'Sugars'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-08-19', 'studyFirstSubmitDate': '2010-08-18', 'studyFirstSubmitQcDate': '2010-08-19', 'lastUpdatePostDateStruct': {'date': '2010-08-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptoms assessment by objective and subjective rating scale', 'timeFrame': '2 hour', 'description': 'VAS - mental sedation (alert-drowsy, muzzy-clear headed, mentally slow-quick witted, attentive-dreamy), physical sedation (strong-feeble, well coordinated-clumsy, lethargic-energetic, incompetent-proficient), tranquilization (calm-excited, contented-discontented, troubled-tranquil, tense-relaxed)'}, {'measure': 'Symptoms assessment by objective and subjective rating scales & CNT', 'timeFrame': '4hour', 'description': 'SANS-alogia and blunted affect, SDSS-Subjective Deficit Syndrome Scale ,self-report questionnaire to measure lack of energy, blunted affect, and difficulty in or altered thinking, consisting of 19 questions, with the scales from 0 to 4 NIDSS-consists of 20 items with a five-point Likert scale (from 0, none to 4, severe) and has three subscales: avolition (five items), blunted affect (five items), and cognition (ten items), CNT-computerized neuropsychological test, VAS'}, {'measure': 'Symptoms assessment by objective and subjective rating scales', 'timeFrame': '24hour', 'description': 'SANS, SDSS, NIDSS, VAS SANS-alogia and blunted affect, SDSS-Subjective Deficit Syndrome Scale ,self-report questionnaire to measure lack of energy, blunted affect, and difficulty in or altered thinking, consisting of 19 questions, with the scales from 0 to 4 NIDSS-consists of 20 items with a five-point Likert scale (from 0, none to 4, severe) and has three subscales: avolition (five items), blunted affect (five items), and cognition (ten items), VAS'}], 'secondaryOutcomes': [{'measure': 'Symptoms assessment by objective rating scale', 'timeFrame': '4hour', 'description': 'BARS-Barnes akathisia rating scale (BAS), consisting of 4 items, identifies drug-induced akathisia and measures severity, SAS-Simpson-angus scale (SAS), consisting of 10 items, measures neuroleptic induced parkinsonism'}, {'measure': 'Symptoms assessment by objective rating scale', 'timeFrame': '24hour', 'description': 'BARS, SAS'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Normal Volunteers']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to investigate the negative symptoms and cognitive function after administration of antipsychotics in healthy volunteer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '38 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Recruited volunteers among normal adults aged from 18 to 38 who responded advertisements for research subjects. Then selected subjects from the applicants using various screening tests - physical and neurological examination including confirming vital signs after examining physical health and sleep habits of volunteers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18-38 years and meet no DSM-IV diagnostic criteria as assessed by using the Structured Clinical Interview for DSM-IV, research version.\n\nExclusion Criteria:\n\n* 1\\) anyone who participated in other clinical trials within 30 days from the start of this clinical trial or is currently participating in one,\n* 2\\) anyone who has progressive disease or in unstable medical condition unfit for the trial,\n* 3\\) anyone who has been diagnosed in psychiatric terms in the past, depends on psychotropic substance, or has overdosed or depended on the substance or alcohol (except for coffee or tobacco) within 1 month from the trial start,\n* 4\\) anyone who is suicidal or highly probable of suicides, or\n* 5\\) anyone who has test results considered clinically meaningful'}, 'identificationModule': {'nctId': 'NCT01185418', 'briefTitle': 'Evaluation of Negative Symptoms and Cognitive Function After Administration of Antipsychotics in Healthy Volunteer', 'organization': {'class': 'OTHER', 'fullName': 'Chonbuk National University Hospital'}, 'officialTitle': 'Evaluation of Negative Symptoms and Cognitive Function After Administration of Antipsychotics in Healthy Volunteer: a Double-blind, Randomized Trial of a Single Dose of Placebo, Haloperidol, Amisulpride, Risperidone and Aripiprazole', 'orgStudyIdInfo': {'id': 'CBIRB0226-22'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'risperidone', 'interventionNames': ['Drug: risperidone']}, {'label': 'aripiprazole', 'interventionNames': ['Drug: aripiprazole']}, {'label': 'haloperidol', 'interventionNames': ['Drug: haloperidol']}, {'label': 'amisulpride', 'interventionNames': ['Drug: amisulpride']}, {'label': 'lactose', 'interventionNames': ['Drug: lactose']}], 'interventions': [{'name': 'risperidone', 'type': 'DRUG', 'armGroupLabels': ['risperidone']}, {'name': 'aripiprazole', 'type': 'DRUG', 'armGroupLabels': ['aripiprazole']}, {'name': 'haloperidol', 'type': 'DRUG', 'armGroupLabels': ['haloperidol']}, {'name': 'amisulpride', 'type': 'DRUG', 'armGroupLabels': ['amisulpride']}, {'name': 'lactose', 'type': 'DRUG', 'armGroupLabels': ['lactose']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jeonju', 'country': 'South Korea', 'facility': 'Chonbuk national university hospital', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chonbuk National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Young Chul Chung/Professor of Psychiatry', 'oldOrganization': 'Chonbuk National University Hospital, Jeonju, Korea'}}}}