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OpenTrials
Completed

NCT Number: NCT00154323

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 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.

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oxcarbazepine

Drug

Primary outcomes

  1. Duration of remission

Secondary outcomes

  1. Daily mood fluctuation

  2. Time to new maniac/hypomanic episode

  3. Time to new depressive episode

  4. Number of relapsed patients at study completion and type/severity of episode

  5. Change from baseline in functional activity

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Sep 12, 2005
Registry last updated
Dec 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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