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An Open-label Extension Study to Evaluate the Safety and Tolerability of Licarbazepine in the Treatment of Manic Episodes of Bipolar I Disorder. | Clinical Trials | Clareo Health

COMPLETEDPHASE3

An Open-label Extension Study to Evaluate the Safety and Tolerability of Licarbazepine in the Treatment of Manic Episodes of Bipolar I Disorder.

A 52-week, Open-label Extension Study to Evaluate the Safety and Tolerability of Licarbazepine 750- 2000 mg/Day in the Treatment of Manic Episodes of Bipolar I Disorder

NCT00228059•Novartis

View on ClinicalTrials.gov

Summary

This extension study is designed to investigate the long-term safety and tolerability of licarbazepine 750-2000 mg/day over 52 weeks in patients who completed the 3-week double-blind study CLIC477D2301.

Detailed Description

A 52-week, open-label extension study to evaluate the safety and tolerability of licarbazepine 750- 2000 mg/day in the treatment of manic episodes of bipolar I disorder

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. written informed consent provided prior to participation in the extension study
•2. successful completion of study CLIC477D2301
•3. willingness and ability to comply with all study requirements

Exclusion Criteria

•1. premature discontinuation from study CLIC477D2301
•2. failure to comply with the study CLIC477D2301 protocol

Locations (1)

Investigational Site

Cerritos, California, United States

Key Dates

Start Date

January 1, 2005

Primary Completion Date

July 1, 2007

Completion Date

July 1, 2007

Last Updated

February 23, 2017

Enrollment

132

ACTUAL participants

Conditions

Bipolar I Disorder

Interventions

Licarbazepine

DRUG

Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder

NCT05303064

SchizophreniaBipolar I Disorder

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RECRUITINGPHASE3

A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)

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Bipolar DisorderBipolar Depression+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 23, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

An Open-label Extension Study to Evaluate the Safety and Tolerability of Licarbazepine in the Treatment of Manic Episodes of Bipolar I Disorder.

Inclusion Criteria

Exclusion Criteria

Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder

A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)

Efficacy and Safety of Magnesium Vitamin B6 in First Episode Bipolar Disorder

Sequential Multiple Assignment Randomized Trial for Bipolar Depression

ERG Components in Schizophrenia and Bipolar Disorder Type I

Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia and Bipolar Disorder (SERENITY III)