Safety and Efficacy Study of Lithium in Bipolar Disorder | NCT00422331

Studies
Safety and Efficacy Study of Lithium in Bipolar Disorder

NCT00422331

Sponsor

JDS Pharmaceuticals

Status

Unknown status

Last Update Posted

Aug 14, 2007Estimated

Enrollment

206Estimated

Phase

Phase 3

Conditions

Bipolar Disorder
Mania

Interventions

Lithium Carbonate Capsule

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Lithium TEAM-1 Study

Status Module

Record Verification Date

Aug 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Not provided

Completion Date

Dec 2007Estimated

First Submitted Date

Jan 11, 2007

First Submission Date that Met QC Criteria

Jan 12, 2007

First Posted Date

Jan 15, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 13, 2007

Last Update Posted Date

Aug 14, 2007Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

206Estimated

Name	Type	Description	Arm Group Labels	Other Names
Lithium Carbonate Capsule	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change from baseline in YMRS score

Secondary Outcomes

Measure	Description	Time Frame
change from baseline in CGI-BP score
change from baseline in MADRS score

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
JDS Pharmaceuticals		New York	New York	10174	United States

Condition Browse Module

MeSH Terms

ID	Term
D001714	Bipolar Disorder
D000087122	Mania

Ancestor Terms

ID	Term
D000068105	Bipolar and Related Disorders
D019964	Mood Disorders
D001523	Mental Disorders
D019954	Neurobehavioral Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016651	Lithium Carbonate

Ancestor Terms

ID	Term
D002254	Carbonates
D000468	Alkalies
D007287	Inorganic Chemicals
D002255	Carbonic Acid

Browse Leaves

Not provided

Browse Branches

Not provided