Safety and Efficacy Study of Lithium in Bipolar Disorder

JDS Pharmaceuticals

Status and phase: Unknown; Phase 3

Conditions: Bipolar Disorder; Mania

Treatments: Drug: Lithium Carbonate Capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT00422331

Lithium TEAM-1 Study

JDS04004

Details and patient eligibility

About

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.

Enrollment: 206 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind