Efficacy of Combined Treatment for Young Bipolar I Disorder - Full Text View

Sponsor:	University of Sao Paulo
Information provided by:	University of Sao Paulo
ClinicalTrials.gov Identifier:	NCT00976794

Purpose

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.

Condition	Intervention	Phase
Bipolar I Disorder	Drug: lithium plus carbamazepine Drug: lithium plus valproate	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Efficacy and Tolerability of the Combination of LIthium and CArbamazepine Compared to Lithium and VALproic Acid in the Treatment of Young Bipolar Patients

Resource links provided by NLM:

Drug Information available for: Divalproex sodium Valproic acid Carbamazepine Lithium carbonate Lithium citrate Valproate Sodium

U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:

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. [ Time Frame: August 2012 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 [ Time Frame: August 2012 ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	January 2009
Estimated Study Completion Date:	August 2012
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: lithium plus carbamazepine combination of the two drugs in standard dosage	Drug: lithium plus carbamazepine Lithium: Starting at 600 mg daily, dose weekly adjusted according to blood serum level (0,6 -1,2mEq/l), efficacy and tolerability. Carbamazepine : 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
Active Comparator: lithium plus valproate combination of the two drugs in standard dosage	Drug: lithium plus valproate Lithium: Starting at 600 mg daily, dose weekly adjusted according to blood serum level (0,6 -1,2mEq/l), efficacy and tolerability. Valproic acid: Starting at 500mg daily, dose weekly adjusted according to blood serum level (50 and 125µg/ml), efficacy and tolerability.

Detailed Description:

After the diagnostic assessments, the patients are allocated for one of the following groups of treatment:

Group I: lithium + valproic acid

Group II: lithium + carbamazepine

Patients 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.

During phase II and III will continue only patients that achieve response, measured according to initial symptoms score in phase I.

Eligibility

Ages Eligible for Study:	18 Years to 35 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical diagnosis of Bipolar Disorder, type I, in current episode (manic/hypomanic, mixed or depression)
The patient or his (her) legal representative should understand the nature of the study and sign the Informed Consent.

Exclusion Criteria:

Schizophrenia or schizoaffective disorder
Mental retardation
Unstable clinical diseases

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00976794

Contacts

Contact: Ricardo Alberto Moreno, MD PhD	+ 55 11 3069 6648	rmoreno@hcnet.usp.br
Contact: Rodolfo Nunes Campos, MD	+ 55 11 3069 6648	rodolfoncampos@hotmail.com

Locations

Brazil
Institute of Psychiatry - University of São Paulo	Recruiting
Sao Paulo, Brazil
Principal Investigator: Ricardo Alberto Moreno, MD PhD
Sub-Investigator: Rodolfo Nunes Campos, MD

Sponsors and Collaborators

University of Sao Paulo

More Information

Publications:

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. Review.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Campos RN, Costa LF, Bio DS, de Souza MG, Garcia CR, Demétrio FN, Moreno DH, Moreno RA. LICAVAL: combination therapy in acute and maintenance treatment of bipolar disorder. Trials. 2010 Jun 23;11:72.

Responsible Party:	Ricardo Alberto Moreno. MD PhD, University of Sao Paulo
ClinicalTrials.gov Identifier:	NCT00976794 History of Changes
Other Study ID Numbers:	2898
Study First Received:	September 11, 2009
Last Updated:	September 11, 2009
Health Authority:	Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:

BD I

Additional relevant MeSH terms:

Valproic Acid
Carbamazepine
Lithium Carbonate
Lithium
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents

Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antipsychotic Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on February 09, 2012