Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2025-12-25 @ 8:33 PM
Study NCT ID:
NCT00071669
Status:
COMPLETED
Last Update Posted:
2013-04-15
First Post:
2003-10-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Acupuncture as a Supplemental Treatment for Bipolar Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001714', 'term': 'Bipolar Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}], 'ancestors': [{'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-11', 'lastUpdateSubmitDate': '2013-04-12', 'studyFirstSubmitDate': '2003-10-29', 'studyFirstSubmitQcDate': '2003-10-29', 'lastUpdatePostDateStruct': {'date': '2013-04-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-10-30', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Mood Disorder', 'Acupuncture'], 'conditions': ['Bipolar Disorder']}, 'referencesModule': {'references': [{'pmid': '19422756', 'type': 'DERIVED', 'citation': 'Dennehy EB, Schnyer R, Bernstein IH, Gonzalez R, Shivakumar G, Kelly DI, Snow DE, Sureddi S, Suppes T. The safety, acceptability, and effectiveness of acupuncture as an adjunctive treatment for acute symptoms in bipolar disorder. J Clin Psychiatry. 2009 Jun;70(6):897-905. doi: 10.4088/JCP.08m04208. Epub 2009 May 5.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effectiveness of acupuncture in the treatment of Bipolar Depression.', 'detailedDescription': 'Patients receive 8 weeks (12 sessions) of acupuncture treatment plus stable medication. Patients are randomly assigned to receive either acupuncture designed to relieve symptoms of depression or acupuncture designed to relieve some other legitimate physical condition. A comparison group of patients who take medication but do not receive acupuncture is assessed to evaluate the effectiveness of medication alone. Patients participate in clinical assessment each week, which includes visiting with a psychiatrist and completing symptom rating scales.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meet DSM-IV criteria for bipolar I disorder or bipolar II disorder\n* Demonstrate symptoms of depression as determined by a minimum score of 25 on the Inventory for Depressive Symptoms-Clinician Rated Scale\n* Have taken stable psychoactive medications for at least 30 days prior to study entry'}, 'identificationModule': {'nctId': 'NCT00071669', 'briefTitle': 'Acupuncture as a Supplemental Treatment for Bipolar Depression', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'Adjunctive Acupuncture as a Treatment for Bipolar Depression', 'orgStudyIdInfo': {'id': 'R03MH061589', 'link': 'https://reporter.nih.gov/quickSearch/R03MH061589', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R03MH061589', 'link': 'https://reporter.nih.gov/quickSearch/R03MH061589', 'type': 'NIH'}, {'id': 'DSIR AT-SO'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Acupuncture', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Bipolar Disorder Clinic and Research Program', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}]}}}