Investigation of Lithium on Signal Transduction, Gene Expression and Brain Myo-Inositol Levels in Manic Patients

Phase 4

Completed

• Conditions: Bipolar Disorder
• Interventions: Drug: Lithium Carbonate

• Registration Number: NCT00870311
• Lead Sponsor: Wayne State University

Brief Summary

This study investigates the effects of Lithium treatment on signal transduction pathways, gene expression and brain neurochemistry and structure in patients with Bipolar disorder. It is hypothesized that specific changes in these markers will correlate with lithium treatment responsiveness.

Detailed Description

This study investigates the effects of blinded lithium treatment longitudinally in patients with bipolar disorder. At baseline and at multiple time points following the initiation of lithium treatment over 4 or more weeks, measures of signal transduction pathways, gene expression and brain neurochemistry and structure were obtained. It is hypothesized that modulation of these measures will be predictive of lithium treatment responsiveness.

Study Timeline

• Study Start: 1996-03
• Primary Completion: 2004-04
• Study Completion: 2004-04
• Status Verified: 2009-03
• Study First Submitted: 2009-03-25
• Study First Submitted QC: 2009-03-25
• Last Update Submitted: 2009-03-25
• Study First Posted: 2009-03-27
• Last Update Posted: 2009-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Meet diagnostic criteria for Bipolar Mood Disorder determined by DSM-IV (SCID)

Exclusion Criteria

• Meeting criteria for any other DSM-IV axis I disorder
• Psychoactive substance abuse or dependence within the past 1 year
• Medical conditions placing patients at increased risk for lithium treatment (including renal disease, hepatic disease, hematological disease)
• Devices/implants or conditions which preclude MRI investigation (including cardiac pacemaker/ICD, aneurysm clips, neurostimulator device, metallic fragments in or near the eye,claustrophobia)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Blinded Lithium	Lithium Carbonate	Bipolar Disorder patients

Primary Outcome Measures

Name	Time	Method
Brain myo-inositol levels	4 weeks

Secondary Outcome Measures

Name	Time	Method
Brain volume	4 weeks
Signal transduction pathway measures	4 weeks
Gene expression levels	4 weeks

Trial Locations

Locations (1)

Wayne State University School of Medicine; 🇺🇸 Detroit, Michigan, United States