Safety and Efficacy Study of Lithium in Bipolar Disorder

JDS Pharmaceuticals206 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

206

Conditions

Bipolar Disorder Mania

Interventions

Lithium Carbonate CapsuleDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

JDS Pharmaceuticals

New York, New York, United States

Outcomes

Primary Outcomes

change from baseline in YMRS score

Secondary Outcomes

change from baseline in CGI-BP score

change from baseline in MADRS score

Data from ClinicalTrials.gov

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