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Completed

NCT Number: NCT00099229

Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar Disorder

This purpose of this study is to evaluate the safety and efficacy of Licarbazepine for the treatment of manic episodes of bipolar disorder.

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Mania Mental Disorders Mood Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigational Site, Dijon, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of bipolar disorder (type I) with manic or mixed episodes (including patients with/without psychotic features or with/without a history of rapid cycling)
  • In need of psychiatric treatment
  • Cooperation and willingness to complete all aspects of the study

Exclusion criteria

  • Current diagnosis other than bipolar I disorder
  • History of schizophrenia or schizoaffective disorder
  • Drug dependence within 1 month prior to study start or testing positive in a urine drug test
  • Suicide attempt within 1 month prior to study start or at immediate risk of harm to self or others
  • Any form of psychotherapy within 1 month prior to study start

Treatment and study plan

Licarbazepine

Drug

Primary outcomes

  1. Mean reduction in manic episodes and major depressive episodes from baseline to endpoint (Week 3).

Secondary outcomes

  1. Major improvement in anxiety and depression from baseline to endpoint (Week 3)

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Tolerability of Licarbazepine 1000-2000mg/Day in the Treatment of Manic Episodes of Bipolar I Disorder Over 3 Weeks

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Dec 10, 2004
Registry last updated
Feb 23, 2017

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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