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.

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00154323

Enrollment

Registered

2005-09-12

Start date

2003-01-31

Completion date

2006-01-31

Last updated

2023-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder

Keywords

Oxcarbazepine, bipolar disorder

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.

Interventions

DRUGOxcarbazepine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* History of bipolar disorder type I or II

Exclusion criteria

* Other serious medical conditions * Treatment with antiepileptic medications Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Duration of remission	—

Secondary

Measure	Time frame
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	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026