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

Sponsor

Wayne State University (Other)

Overall Status

Completed

CT.gov ID

NCT00870311

Collaborator

National Institute of Mental Health (NIMH) (NIH)

Enrollment

Location

Arm

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bipolar Disorder	Drug: Lithium Carbonate	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

28 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

Single (Participant)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Mar 1, 1996

Actual Primary Completion Date :

Apr 1, 2004

Actual Study Completion Date :

Apr 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Blinded Lithium Bipolar Disorder patients	Drug: Lithium Carbonate 300mg PO, three times daily with dose titrated to obtain a therapeutic plasma level of 0.8 to 1.2meq/L) over the first week of treatment. Total duration is a minimum of 3 weeks. Medication is dispensed in the form of blinded research capsules. Other Names: Eskalith Lithonate Lithane Lithotabs Lithobid

Arm

Intervention/Treatment

Experimental: Blinded Lithium

Bipolar Disorder patients

Drug: Lithium Carbonate

300mg PO, three times daily with dose titrated to obtain a therapeutic plasma level of 0.8 to 1.2meq/L) over the first week of treatment. Total duration is a minimum of 3 weeks. Medication is dispensed in the form of blinded research capsules.

Other Names:

Eskalith

Lithonate

Lithane

Lithotabs

Lithobid

Outcome Measures

Primary Outcome Measures

Brain myo-inositol levels [4 weeks]

Secondary Outcome Measures

Signal transduction pathway measures [4 weeks]
Gene expression levels [4 weeks]
Brain volume [4 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wayne State University School of Medicine	Detroit	Michigan	United States	48201

Sponsors and Collaborators

Wayne State University
National Institute of Mental Health (NIMH)

Investigators

Principal Investigator: Husseini K Manji, MD, Wayne State University, National Institute of Mental Health
Principal Investigator: Debra A Glitz, MD, Wayne State University
Principal Investigator: Gregory J Moore, MD, PhD, Wayne State University