Efficacy of Combined Treatment for Young Bipolar I Disorder
NCT ID: NCT00976794
Last Updated: 2013-07-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
40 participants
INTERVENTIONAL
2009-01-31
2012-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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lithium plus carbamazepine
combination of the two drugs in standard dosage
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
lithium plus valproate
combination of the two drugs in standard dosage
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.
Interventions
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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
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.
Eligibility Criteria
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Inclusion Criteria
* The patient or his (her) legal representative should understand the nature of the study and sign the Informed Consent.
Exclusion Criteria
* Mental retardation
* Unstable clinical diseases
18 Years
35 Years
ALL
No
Sponsors
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University of Sao Paulo
OTHER
Responsible Party
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Ricardo Alberto Moreno, M.D., Ph.D.
MD PhD
Locations
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Institute of Psychiatry - University of São Paulo
São Paulo, São Paulo, Brazil
Countries
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References
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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.
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.
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.
Other Identifiers
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2898
Identifier Type: -
Identifier Source: org_study_id
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