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.

Bipolar Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00154323
• Other study ID #: CTRI476BES03
• Status: Completed
• Phase: Phase 4
• Start date: January 2003
• Est. completion date: January 2006

Study information

• Verified date: December 2023
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: January 2006
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Drug:
• Oxcarbazepine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

References & Publications (1)

Vieta E, Cruz N, Garcia-Campayo J, de Arce R, Manuel Crespo J, Valles V, Perez-Blanco J, Roca E, Manuel Olivares J, Morinigo A, Fernandez-Villamor R, Comes M. A double-blind, randomized, placebo-controlled prophylaxis trial of oxcarbazepine as adjunctive — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of remission
Secondary	Daily mood fluctuation
Secondary	Time to new maniac/hypomanic episode
Secondary	Time to new depressive episode
Secondary	Number of relapsed patients at study completion and type/severity of episode
Secondary	Change from baseline in functional activity