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

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ClinicalTrials.gov Identifier: NCT00976794
Recruitment Status : Completed
First Posted : September 14, 2009
Last Update Posted : July 12, 2013
Sponsor:
Information provided by (Responsible Party):
Ricardo Alberto Moreno, M.D., Ph.D., University of Sao Paulo

Brief Summary:
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 or disease Intervention/treatment Phase
Bipolar I Disorder Drug: lithium plus carbamazepine Drug: lithium plus valproate Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : January 2009
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00976794


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

Publications:
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
First Posted: September 14, 2009    Key Record Dates
Last Update Posted: July 12, 2013
Last Verified: July 2013

Keywords provided by Ricardo Alberto Moreno, M.D., Ph.D., University of Sao Paulo:
BD I

Additional relevant MeSH terms:
Lithium Carbonate
Valproic Acid
Carbamazepine
Antidepressive Agents
Psychotropic Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Anticonvulsants
GABA Agents
Neurotransmitter Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers