Efficacy of Combined Treatment for Young Bipolar I Disorder

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy and Tolerability of the Combination of LIthium and CArbamazepine Compared to Lithium and VALproic Acid in the Treatment of Young Bipolar Patients

Conditions
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Bipolar I Disorder

Intervention / Treatment
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* Drug: lithium plus carbamazepine
* Drug: lithium plus valproate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lithium plus carbamazepine<br>combination of the two drugs in standard dosage | Drug: lithium plus carbamazepine<br>* 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<br>|
| Active Comparator: lithium plus valproate<br>combination of the two drugs in standard dosage | Drug: lithium plus valproate<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | August 2012 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | August 2012 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BD I