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

NCT ID: NCT00107926

Last Updated: 2017-03-22

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

343 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2007-08-31

Brief Summary

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The purpose of this study is to evaluate the effectiveness and tolerability of an investigational drug for the treatment of manic episodes of bipolar disorder. The investigational drug will be given as additional treatment with either lithium or valproate, which are already FDA (Food and Drug Administration)-approved treatments for mania.

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

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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licarbazepine

Group Type EXPERIMENTAL

Licarbazepine

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Licarbazepine

Intervention Type DRUG

Placebo

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

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Investigational Site

La Palma, California, United States

Site Status

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Kansas City, Kansas, United States

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Shreveport, Louisiana, United States

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Somerville, Massachusetts, United States

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Farmington Hills, Michigan, United States

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Staten Island, New York, United States

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Madison, Tennessee, United States

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Bellaire, Texas, United States

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Dallas, Texas, United States

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Bellevue, Washington, United States

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Kirkland, Washington, United States

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West Allis, Wisconsin, United States

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Novartis Investigational Site

Vienna, , Austria

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Greater Sudbury, , Canada

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Kelowna, , Canada

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London, , Canada

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Montreal, , Canada

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Vancouver, , Canada

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Verdun, , Canada

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Guatemala

Bogotá, , Colombia

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Guatemala

Medellín, , Colombia

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Guatemala

Pareira, , Colombia

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Brno, , Czechia

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Hradec Králové, , Czechia

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Prague, , Czechia

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Berlin, , Germany

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Bochum, , Germany

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Dresden, , Germany

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Ingolstadt, , Germany

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Mannheim, , Germany

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Würzburg, , Germany

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Guatemala City, , Guatemala

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Lima, , Peru

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Moscow, , Russia

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Yaroslavl, , Russia

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Bojnice, , Slovakia

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Michalovce, , Slovakia

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Durban, , South Africa

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Dnipro, , Ukraine

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Kiev, , Ukraine

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Luhansk, , Ukraine

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Odesa, , Ukraine

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Simferopol, , Ukraine

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Caracas, , Venezuela

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Countries

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United States Austria Canada Colombia Czechia Germany Guatemala Peru Russia Slovakia South Africa Ukraine Venezuela

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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CLIC477D2303

Identifier Type: -

Identifier Source: org_study_id

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