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

NCT ID: NCT00099229

Last Updated: 2017-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2006-08-31

Brief Summary

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

Detailed Description

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Conditions

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Bipolar Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Licarbazepine

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Investigational Site

Little Rock, Arkansas, United States

Site Status

Investigational Site

Cerritos, California, United States

Site Status

Investigational Site

San Diego, California, United States

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Port Charlotte, Florida, United States

Site Status

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Indianapolis, Indiana, United States

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Newton, Kansas, United States

Site Status

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Las Vegas, Nevada, United States

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Raleigh, North Carolina, United States

Site Status

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Cincinnati, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Philadelphia, Pennsylvania, United States

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Austin, Texas, United States

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Bellaire, Texas, United States

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Houston, Texas, United States

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Investigational Site

Houston, Texas, United States

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Investigational Site

Kirkland, Washington, United States

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Investigational Site

Dijon, , France

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Investigational Site

Strasbourg, , France

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Investigational Site

Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Investigational Site

Saint Petersburg, , Russia

Site Status

Countries

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United States France Russia

Related Links

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http://www.novartisclinicaltrials.com/etrials/DiseaseID10/Bipolar-Disorder-clinical-trials.go

Click here for further information and to find an investigational site near you

Other Identifiers

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CLIC477D2301

Identifier Type: -

Identifier Source: org_study_id

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