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

NCT ID: NCT00107939

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

453 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2007-04-30

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 therapy to one of the five following medications: risperidone, olanzapine, quetiapine, ziprasidone, or aripiprazole. These medications are already FDA (Food and Drug Administration)-approved treatments for mania.

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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

Orange, California, United States

Site Status

Investigational Site

Pico Rivera, California, United States

Site Status

Investigational Site

San Diego, California, United States

Site Status

Investigational Site

San Diego, California, United States

Site Status

Investigational Site

Boca Raton, Florida, United States

Site Status

Investigational Site

Atlanta, Georgia, United States

Site Status

Investigational Site

Chicago, Illinois, United States

Site Status

Investigational Site

Joliet, Illinois, United States

Site Status

Investigational Site

Indianapolis, Indiana, United States

Site Status

Investigational Site

Topeka, Kansas, United States

Site Status

Investigational Site

Kansas City, Missouri, United States

Site Status

Investigational Site

St Louis, Missouri, United States

Site Status

Invetigational Site

Brooklyne, New York, United States

Site Status

Investigational Site

Cedarhurst, New York, United States

Site Status

Investigational Site

New York, New York, United States

Site Status

Investigational Site

Cincinnati, Ohio, United States

Site Status

Investigational Site

Columbus, Ohio, United States

Site Status

Investigational Site

Providence, Rhode Island, United States

Site Status

Investigational Site

Bellaire, Texas, United States

Site Status

Investigational Site

Bellevue, Washington, United States

Site Status

Investigational Site

West Allis, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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CLIC477D2302

Identifier Type: -

Identifier Source: org_study_id

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