Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-03-09 @ 4:48 AM
Study NCT ID:
NCT00976794
Status:
COMPLETED
Last Update Posted:
2013-07-12
First Post:
2009-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Combined Treatment for Young Bipolar I Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008094', 'term': 'Lithium'}, {'id': 'D002220', 'term': 'Carbamazepine'}, {'id': 'D014635', 'term': 'Valproic Acid'}], 'ancestors': [{'id': 'D008672', 'term': 'Metals, Alkali'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D019565', 'term': 'Metals, Light'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D003984', 'term': 'Dibenzazepines'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010421', 'term': 'Pentanoic Acids'}, {'id': 'D014631', 'term': 'Valerates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005232', 'term': 'Fatty Acids, Volatile'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-10', 'studyFirstSubmitDate': '2009-09-11', 'studyFirstSubmitQcDate': '2009-09-11', 'lastUpdatePostDateStruct': {'date': '2013-07-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The main outcome will be the number of patients that achieve and remain in remission to each treatment at the end of each phase of the study.', 'timeFrame': 'August 2012'}], 'secondaryOutcomes': [{'measure': 'Secondary outcome will include the proportion of patients that had response but not remission to each treatment at the end of each phase of the study', 'timeFrame': 'August 2012'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['BD I'], 'conditions': ['Bipolar I Disorder']}, 'referencesModule': {'references': [{'pmid': '15820265', 'type': 'BACKGROUND', 'citation': 'Fountoulakis KN, Vieta E, Sanchez-Moreno J, Kaprinis SG, Goikolea JM, Kaprinis GS. Treatment guidelines for bipolar disorder: a critical review. J Affect Disord. 2005 May;86(1):1-10. doi: 10.1016/j.jad.2005.01.004.'}, {'pmid': '31655626', 'type': 'DERIVED', 'citation': 'Missio G, Moreno DH, Demetrio FN, Soeiro-de-Souza MG, Dos Santos Fernandes F, Barros VB, Moreno RA. A randomized controlled trial comparing lithium plus valproic acid versus lithium plus carbamazepine in young patients with type 1 bipolar disorder: the LICAVAL study. Trials. 2019 Oct 26;20(1):608. doi: 10.1186/s13063-019-3655-2.'}, {'pmid': '20573223', 'type': 'DERIVED', 'citation': 'Campos RN, Costa LF, Bio DS, Soeiro de Souza MG, Garcia CR, Demetrio FN, Moreno DH, Moreno RA. LICAVAL: combination therapy in acute and maintenance treatment of bipolar disorder. Trials. 2010 Jun 23;11:72. doi: 10.1186/1745-6215-11-72.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the efficacy of the combination of lithium and carbamazepine compared with lithium and valproate treating young bipolar patients.', 'detailedDescription': 'After the diagnostic assessments, the patients are allocated for one of the following groups of treatment:\n\nGroup I: lithium + valproic acid\n\nGroup II: lithium + carbamazepine\n\nPatients will be followed up for 8 weeks in phase I (acute treatment), 6 months in phase II (continuation treatment) and 12 months in phase III (maintenance treatment). Scales raters will be blind to the treatment.\n\nDuring phase II and III will continue only patients that achieve response, measured according to initial symptoms score in phase I.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of Bipolar Disorder, type I, in current episode (manic/hypomanic, mixed or depression)\n* The patient or his (her) legal representative should understand the nature of the study and sign the Informed Consent.\n\nExclusion Criteria:\n\n* Schizophrenia or schizoaffective disorder\n* Mental retardation\n* Unstable clinical diseases'}, 'identificationModule': {'nctId': 'NCT00976794', 'acronym': 'LICAVAL', 'briefTitle': 'Efficacy of Combined Treatment for Young Bipolar I Disorder', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Efficacy and Tolerability of the Combination of LIthium and CArbamazepine Compared to Lithium and VALproic Acid in the Treatment of Young Bipolar Patients', 'orgStudyIdInfo': {'id': '2898'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'lithium plus carbamazepine', 'description': 'combination of the two drugs in standard dosage', 'interventionNames': ['Drug: lithium plus carbamazepine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'lithium plus valproate', 'description': 'combination of the two drugs in standard dosage', 'interventionNames': ['Drug: lithium plus valproate']}], 'interventions': [{'name': 'lithium plus carbamazepine', 'type': 'DRUG', 'description': 'Lithium: Starting at 600 mg daily, dose weekly adjusted according to blood serum level (0,6 -1,2mEq/l), efficacy and tolerability.\n\nCarbamazepine : Starting at 200mg daily and getting 600 mg daily at the end of the first week. Dose weekly adjusted according to blood serum level (8 and 12µg/ml), efficacy and tolerability', 'armGroupLabels': ['lithium plus carbamazepine']}, {'name': 'lithium plus valproate', 'type': 'DRUG', 'description': 'Lithium: Starting at 600 mg daily, dose weekly adjusted according to blood serum level (0,6 -1,2mEq/l), efficacy and tolerability.\n\nValproic acid: Starting at 500mg daily, dose weekly adjusted according to blood serum level (50 and 125µg/ml), efficacy and tolerability.', 'armGroupLabels': ['lithium plus valproate']}]}, 'contactsLocationsModule': {'locations': [{'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Institute of Psychiatry - University of São Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Ricardo Alberto Moreno, M.D., Ph.D.', 'investigatorAffiliation': 'University of Sao Paulo'}}}}