Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2026-01-24 @ 6:30 AM
Study NCT ID:
NCT03065933
Status:
TERMINATED
Last Update Posted:
2017-04-26
First Post:
2012-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Extended-Release Form of Clonidine as an Anti-Manic Agent: An Add-on, Open-Label Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001714', 'term': 'Bipolar Disorder'}, {'id': 'D000087122', 'term': 'Mania'}], 'ancestors': [{'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003000', 'term': 'Clonidine'}], 'ancestors': [{'id': 'D048288', 'term': 'Imidazolines'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'eliebson@partners.org', 'phone': '617-855-2284', 'title': 'Elizabeth S. Liebson, M.D.', 'organization': 'McLean Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'description': 'No data was collected on the 5 participants enrolled, except for region of enrollment, before the study terminated.', 'eventGroups': [{'id': 'EG000', 'title': 'Clonidine as an Antimanic Agent', 'description': 'Subjects with Bipolar Disorder, Mania receive an extended-release form of clonidine on the second day of this 3-day study. Rating scales, record of sleep, and a questionnaire of adverse effects is recorded on each of the three days.\n\nextended-release clonidine: Subjects will received 0.2 mg extended-release clonidine twice on second day of this three-day study.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Score on a Mania Rating Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Clonidine as an Antimanic Agent', 'description': 'Subjects with Bipolar Disorder, Mania receive an extended-release form of clonidine on the second day of this 3-day study. Rating scales, record of sleep, and a questionnaire of adverse effects is recorded on each of the three days.\n\nextended-release clonidine: Subjects will received 0.2 mg extended-release clonidine twice on second day of this three-day study.'}], 'timeFrame': '3 days', 'description': 'Mania rating scale to be performed each day of this 3 day study.', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected on the 5 participants, except for region of enrollment, before the study terminated.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Clonidine as an Antimanic Agent', 'description': 'Subjects with Bipolar Disorder, Mania receive an extended-release form of clonidine on the second day of this 3-day study. Rating scales, record of sleep, and a questionnaire of adverse effects is recorded on each of the three days.\n\nextended-release clonidine: Subjects will received 0.2 mg extended-release clonidine twice on second day of this three-day study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'study terminated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Clonidine as an Antimanic Agent', 'description': 'Subjects with Bipolar Disorder, Mania receive an extended-release form of clonidine on the second day of this 3-day study. Rating scales, record of sleep, and a questionnaire of adverse effects is recorded on each of the three days.\n\nextended-release clonidine: Subjects will received 0.2 mg extended-release clonidine twice on second day of this three-day study.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'No data was collected on the 5 participants, except for region of enrollment, before the study terminated.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female'}, {'title': 'Male'}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'No data was collected on the 5 participants, except for region of enrollment, before the study terminated.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'All participants were enrolled in the United States, but no other data was collected.'}], 'populationDescription': 'No data besides region of enrollment was collected on these participants before the study terminated.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Subjects with Bipolar Disorder, mania will receive an extended-release from of clonidine on the second day of this 3-day study. Rating scale, record of sleep, and a questionnaire of adverse effects will be recorded on each of the 3 days.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-15', 'studyFirstSubmitDate': '2012-11-06', 'resultsFirstSubmitDate': '2017-03-15', 'studyFirstSubmitQcDate': '2017-02-22', 'lastUpdatePostDateStruct': {'date': '2017-04-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-15', 'studyFirstPostDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2017-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Score on a Mania Rating Scale', 'timeFrame': '3 days', 'description': 'Mania rating scale to be performed each day of this 3 day study.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mania', 'clonidine', 'bipolar disorder'], 'conditions': ['Bipolar Disorder, Mania']}, 'descriptionModule': {'briefSummary': 'The investigators plan to to study an extended-release form of clonidine, which the investigators hope will be even better tolerated than the immediate-release form, as an antimanic agent. Subjects will receive an extended-release form of clonidine in addition to their usual medication regimen on the second day of this three-day study. Rating scales, a record of sleep, and a questionnaire of adverse effects will be recorded on each of the 3 days. Any medication changes made by the attending psychiatrist and prns administered will be recorded throughout the study.', 'detailedDescription': 'Clonidine has been reported to be effective in a variety of hyperadrenergic states, including mania. It is generally well-tolerated and does not result in the severe adverse effects that are associated with many antipsychotics and mood stabilizers used in the treatment of mania, such as weight gain and akathisia. There is some suggestion that clonidine may be particularly effective in a subset of refractory cases and in patients who cannot tolerate antipsychotic medications or lithium. The investigators plan to to study an extended-release form of clonidine, which the investigators hope will be even better tolerated than the immediate-release form, as an antimanic agent. Subjects will receive an extended-release form of clonidine in addition to their usual medication regimen on the second day of this three-day study. Rating scales, a record of sleep, and a questionnaire of adverse effects will be recorded on each of the 3 days. Any medication changes made by the attending psychiatrist and prns administered will be recorded throughout the study. The investigators believe that studying as few as 10 subjects will give the investigators a sense as to whether the addition of clonidine is helpful in reducing manic symptoms and if the rate of adverse effects is unacceptable.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* meet SCID criteria for bipolar disorder, type I, Mania with YMRS \\> 15\n* No significant improvement in symptoms after three or more days of hospitalization\n* documented medical evaluation without identified acute or serious medical illness\n* negative pregnancy test in women of child-bearing age\n\nExclusion Criteria:\n\n* involuntary commitment or lack of capacity to provide informed consent\n* low blood pressure'}, 'identificationModule': {'nctId': 'NCT03065933', 'briefTitle': 'An Extended-Release Form of Clonidine as an Anti-Manic Agent: An Add-on, Open-Label Study', 'organization': {'class': 'OTHER', 'fullName': 'Mclean Hospital'}, 'officialTitle': 'An Extended-Release Form of Clonidine as an Anti-Manic Agent: An Add-On, Open-Label Study', 'orgStudyIdInfo': {'id': '2011-P-002018/1; McLean'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'clonidine as an antimanic agent', 'description': 'Subjects with Bipolar Disorder, Mania receive an extended-release form of clonidine on the second day of this 3-day study. Rating scales, record of sleep, and a questionnaire of adverse effects is recorded on each of the three days.', 'interventionNames': ['Drug: extended-release clonidine']}], 'interventions': [{'name': 'extended-release clonidine', 'type': 'DRUG', 'otherNames': ['Kapvay'], 'description': 'Subjects will received 0.2 mg extended-release clonidine twice on second day of this three-day study.', 'armGroupLabels': ['clonidine as an antimanic agent']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Bruce Cohen, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Mclean Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'IPD to be shared via clinicaltrials.gov, publication, or personal request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mclean Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'Elizabeth S. Liebson', 'investigatorAffiliation': 'Mclean Hospital'}}}}