Ignite Creation Date:
2025-12-24 @ 10:20 PM
Ignite Modification Date:
2025-12-25 @ 7:53 PM
Study NCT ID:
NCT01184235
Status:
COMPLETED
Last Update Posted:
2014-01-06
First Post:
2010-08-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multidimensional Measurement of Psychopharmacological Treatment Response
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014150', 'term': 'Antipsychotic Agents'}, {'id': 'D000928', 'term': 'Antidepressive Agents'}, {'id': 'D000697', 'term': 'Central Nervous System Stimulants'}], 'ancestors': [{'id': 'D014149', 'term': 'Tranquilizing Agents'}, {'id': 'D002492', 'term': 'Central Nervous System Depressants'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D011619', 'term': 'Psychotropic Drugs'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-02', 'studyFirstSubmitDate': '2010-08-12', 'studyFirstSubmitQcDate': '2010-08-17', 'lastUpdatePostDateStruct': {'date': '2014-01-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Actigraphic Measurement', 'timeFrame': 'Three week actigraphic measurement periods', 'description': "Actigraphic measurements are recorded every 30 seconds during three week measurement periods. The actigraphic measurements will be made utilizing an Actiwatch (AW-64 Phillips-Rispironics, Inc.), placed on the subject's non-dominant wrist. The measurements will occur every thirty seconds for approximately 21 consecutive days. Actigraphic measurements collected at this frequency reflect circadian patterns of interest; discern sleep states and characterize activity and activity patterns."}], 'secondaryOutcomes': [{'measure': 'Operationally Defined Observations', 'timeFrame': 'Randomly repeated treatment course observational measurements during actigraphic measurement periods', 'description': 'The Systematic Observation Scale™ utilizes operationally defined symptoms that are presented to the primary observer (self or parent) for determination regarding the percentage of time symptoms are present. Target symptoms will be defined at baseline. Systematic Observation Scale measurements will be obtained at baseline and weekly post-treatment for periods defined as treatment initiation, treatment adjustment or treatment-course longitudinal.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Circadian Disorders', 'Autism Spectrum Disorders', 'Mood Disorders', 'Executive Functioning', 'Pediatric Mood Disorders'], 'conditions': ['Autism Spectrum Disorders', 'Mood Disorders', 'Sleep Disorders', 'Attention Deficit Disorders']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'B. Duke and D. Staton,'}]}, 'descriptionModule': {'briefSummary': 'The study examines actigraphic, observational, psychometric and associated repeated measurements obtained prior to and during psychopharmacological treatment.', 'detailedDescription': 'Baseline actigraphic measurements, multi-symptom operationally defined observations and psychometric data will be established and repeated to measure treatment response. Additional biological and biometric measures that have potential to further characterize the cohorts under study or treatment response will be collected as practical and when possible.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children and adults, male or female receiving or anticipating pharmacological intervention and their non-affected first degree relatives will be invited to participate based on institutional actiwatch availability. Since children are the focus of the Child Psychopharmacology Institute they will be the primary recruitment focus, however, adult subjects may include non-affected first degree relatives or others who represent designated cohort groups and will be accepted based on actiwatch availabilty.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of:\n* Autism Spectrum Disorder\n* Mood Disorder\n* Attention Deficit Hyperactivity Disorder\n* Unaffected First Degree Relative of Study Subject\n* Anticipation of pharmacological intervention or current pharmacological intervention\n\nExclusion Criteria:\n\nInability to wear an actigraphy watch'}, 'identificationModule': {'nctId': 'NCT01184235', 'briefTitle': 'Multidimensional Measurement of Psychopharmacological Treatment Response', 'organization': {'class': 'OTHER', 'fullName': 'Child Psychopharmacology Institute'}, 'officialTitle': 'Actigraphic, Observational, Psychometric and Biological Measurement of Psychopharmacological Treatment Response', 'orgStudyIdInfo': {'id': 'Act3'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Autism Spectrum Disorders', 'description': 'This group will include those receiving or anticipating receiving pharmacological intervention whose primary diagnosis is Autism Spectrum Disorder', 'interventionNames': ['Drug: Pharmacological Intervention']}, {'label': 'Attention Deficit Hyperactivity Disorder', 'description': 'This group will include those receiving or anticipating receiving pharmacological intervention whose primary diagnosis is Attention Deficit Hyperactivity Disorder.', 'interventionNames': ['Drug: Pharmacological Intervention']}, {'label': 'Unaffected 1st Degree Relatives', 'description': "This group will include unaffected, non treated first degree relatives of this study's subjects receiving or anticipating receiving pharmacological intervention."}, {'label': 'Mood Disorders', 'description': 'This group will include those receiving or anticipating receiving pharmacological intervention whose primary diagnosis is mood disorder.', 'interventionNames': ['Drug: Pharmacological Intervention']}], 'interventions': [{'name': 'Pharmacological Intervention', 'type': 'DRUG', 'otherNames': ['antipsychotics', 'antidepressants', 'mood stabilizers', 'stimulants', 'NMDA antagonists'], 'description': 'This study will include those anticipating or receiving any pharmacological intervention', 'armGroupLabels': ['Attention Deficit Hyperactivity Disorder', 'Autism Spectrum Disorders', 'Mood Disorders']}]}, 'contactsLocationsModule': {'locations': [{'zip': '58103', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Child Psychopharmacology Institute', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}], 'overallOfficials': [{'name': 'Bill J Duke, M.A., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Child Psychopharmacology Institute'}, {'name': 'Robert D Staton, Ph.D., M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Child Psychopharmacology Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Child Psychopharmacology Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}