NCT00422331

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
206

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2007

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 15, 2007

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

August 14, 2007

Status Verified

August 1, 2007

First QC Date

January 11, 2007

Last Update Submit

August 13, 2007

Conditions

Bipolar DisorderMania

Keywords

Bipolar I DisorderBipolar DisorderLithium

Outcome Measures

Primary Outcomes (1)

  • change from baseline in YMRS score

Secondary Outcomes (2)

  • change from baseline in CGI-BP score

  • change from baseline in MADRS score

Interventions

Lithium Carbonate CapsuleDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • History of rapid cycling;
  • History of hypersensitivity or adverse reaction to lithium

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

JDS Pharmaceuticals

New York, New York, 10174, United States

Location

MeSH Terms

Conditions

Bipolar DisorderMania

Interventions

Lithium Carbonate

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CarbonatesAlkaliesInorganic ChemicalsCarbonic AcidCarbon Compounds, InorganicLithium Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 11, 2007

First Posted

January 15, 2007

Study Start

January 1, 2007

Study Completion

December 1, 2007

Last Updated

August 14, 2007

Record last verified: 2007-08

Locations

US(1)