Efficacy of Combined Treatment for Young Bipolar I Disorder (LICAVAL)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ricardo Alberto Moreno, M.D., Ph.D., University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00976794
First received: September 11, 2009
Last updated: July 10, 2013
Last verified: July 2013
  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 4

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:


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 ]

Enrollment: 40
Study Start Date: January 2009
Study Completion Date: June 2012
Primary Completion Date: June 2012 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Brazil
Institute of Psychiatry - University of São Paulo
Sao Paulo, Brazil
Sponsors and Collaborators
University of Sao Paulo
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ricardo Alberto Moreno, M.D., Ph.D., 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: July 10, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
BD I

Additional relevant MeSH terms:
Disease
Pathologic Processes
Lithium
Lithium Carbonate
Carbamazepine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Antimanic Agents
Antidepressive Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticonvulsants
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014