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Safety and Efficacy Study of Lithium in Bipolar Disorder

NCT ID: NCT00422331

Last Updated: 2007-08-14

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

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

206 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2007-12-31

Brief Summary

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The purpose of this study is to determine whether Lithium is safe and effective in the treatment of Bipolar I Disorder subjects with symptoms of acute mania.

Detailed Description

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Conditions

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Bipolar Disorder Mania

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Lithium Carbonate Capsule

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of Bipolar 1 Disorder;
* Hospitalized or in the process of being hospitalized for a manic or mixed episode

Exclusion Criteria

* History of rapid cycling;
* History of hypersensitivity or adverse reaction to lithium
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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JDS Pharmaceuticals

INDUSTRY

Sponsor Role lead

Locations

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JDS Pharmaceuticals

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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Lithium TEAM-1 Study

Identifier Type: -

Identifier Source: secondary_id

JDS04004

Identifier Type: -

Identifier Source: org_study_id