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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lithium plus carbamazepine | Experimental | combination of the two drugs in standard dosage |
|
| lithium plus valproate | Active Comparator | combination of the two drugs in standard dosage |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lithium plus carbamazepine | Drug | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Psychiatry - University of São Paulo | São Paulo | São Paulo | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15820265 | Background | 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. | |
| 31655626 | Derived | 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. |
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| ID | Term |
|---|---|
| D008094 | Lithium |
| D002220 | Carbamazepine |
| D014635 | Valproic Acid |
| ID | Term |
|---|---|
| D008672 | Metals, Alkali |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019565 | Metals, Light |
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|
| lithium plus valproate | Drug | 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. |
|
| 20573223 | Derived | 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. |
| D008670 |
| Metals |
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D010421 | Pentanoic Acids |
| D014631 | Valerates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005232 | Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |