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...
Date First Received: September 8, 2005
Last Updated: November 29, 2007
Verified by: Novartis, November 2007
Clinical Trial Phase: Phase 4 | Start Date: January 2003
Overall Status: Completed
Estimated Enrollment: 60
Brief Summary
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”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Oxcarbazepine
Outcome Measures for this Clinical Trial
Primary Measures
- Duration of remission
Secondary Measures
- Daily mood fluctuation
- Time 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
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Clinical Trial Sponsor Information
Lead Sponsor: Novartis
Overall Clinical Trial Officials and Contacts
Eduard Vieta, MD Principal Investigator Hospital Clinic, Universitary of Barcelona
Additional Information
Information obtained from ClinicalTrials.gov on October 10, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00154323
Study ID Number: CTRI476BES03
ClinicalTrials.gov Identifier: NCT00154323
Health Authority: Spain: Ministry of Health
Clinical Trials Authorship and Review
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