Efficacy of Combined Treatment for Young Bipolar I Disorder
Information source: University of Sao Paulo
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bipolar I Disorder
Intervention: lithium plus carbamazepine (Drug); lithium plus valproate (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University of Sao Paulo Overall contact:
Ricardo Alberto Moreno, MD PhD, Phone: + 55 11 3069 6648, Email: rmoreno@hcnet.usp.br
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.
Clinical Details
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 design: Treatment, Randomized, Single Blind (Outcomes Assessor), Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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.
Secondary outcome: 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
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
Minimum age: 18 Years.
Maximum age: 35 Years.
Gender(s): Both.
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
Locations and Contacts
Ricardo Alberto Moreno, MD PhD, Phone: + 55 11 3069 6648, Email: rmoreno@hcnet.usp.br
Institute of Psychiatry - University of São Paulo, Sao Paulo, Brazil; Recruiting
Ricardo Alberto Moreno, MD PhD, Principal Investigator
Rodolfo Nunes Campos, MD, Sub-Investigator
Additional Information
Mood disorder unit of Institute of psychiatry - University of Sao Paulo
Related publications: 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. Review.
Starting date: January 2009
Ending date: August 2012
Last updated: September 11, 2009
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