Safety and Efficacy Study of Lithium in Bipolar Disorder

Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter, Efficacy and Safety Study of Lithium in Bipolar I Disorder

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00422331

Enrollment

206

Registered

2007-01-15

Start date

2007-01-31

Completion date

2007-12-31

Last updated

2007-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder, Mania

Keywords

Bipolar I Disorder, Bipolar Disorder, Lithium

Brief summary

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.

Interventions

DRUGLithium Carbonate Capsule

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
change from baseline in YMRS score	—

Secondary

Measure	Time frame
change from baseline in CGI-BP score	—
change from baseline in MADRS score	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026