The Efficacy and Safety of Oral Oxcarbazepine 300-1200 mg/Day as Adjuvant Therapy in the Treatment of Bipolar Disorder I or II This Study is Not Being Conducted in the United States.
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bipolar Disorder
Intervention: Oxcarbazepine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Eduard Vieta, MD, Principal Investigator, Affiliation: Hospital Clinic, Universitary of Barcelona
Summary
Bipolar disorder is a psychiatric illness with clinical characteristics of mixed mania,
grandiose delusions, and suicidality. This study will investigate the efficacy a safety of
oxcarbazepine in the treatment of patients with bipolar disorder type I or II.
Clinical Details
Official title: A Multi-Center, Randomized, Double-Blind, Parallel Group, Placebo-Controlled 52 Weeks Clinical Trial to Evaluate Efficacy and Safety of Oxcarbazepine p.o.(300-1200 mg/Day) as Adjuvant Therapy in the Bipolar Disorder I or II Treatment
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Duration of remission
Secondary outcome: Daily mood fluctuationTime to new maniac/hypomanic episode Time to new depressive episode Number of relapsed patients at study completion and type/severity of episode Change from baseline in functional activity
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- History of bipolar disorder type I or II
Exclusion Criteria:
- Other serious medical conditions
- Treatment with antiepileptic medications
Other protocol-defined inclusion/exclusion criteria may apply.
Locations and Contacts
Additional Information
Starting date: January 2003
Ending date: January 2006
Last updated: November 29, 2007
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