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Clinical Trials/NCT00154323
NCT00154323
Completed
Phase 4

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

Novartis0 sites55 target enrollmentJanuary 2003
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ConditionsBipolar Disorder
DrugsOxcarbazepine

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Bipolar Disorder
Sponsor
Novartis
Enrollment
55
Primary Endpoint
Duration of remission
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
January 2003
End Date
January 2006
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Novartis
Responsible Party
Sponsor

Eligibility 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.

Outcomes

Primary Outcomes

Duration of remission

Secondary Outcomes

  • Time to new maniac/hypomanic episode
  • Time to new depressive episode
  • Change from baseline in functional activity
  • Daily mood fluctuation
  • Number of relapsed patients at study completion and type/severity of episode

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