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

Condition(s) targeted: Bipolar Disorder

Intervention: Lithium Carbonate (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Wayne State University

Official(s) and/or principal investigator(s):
Husseini K Manji, MD, Principal Investigator, Affiliation: Wayne State University, National Institute of Mental Health
Debra A Glitz, MD, Principal Investigator, Affiliation: Wayne State University
Gregory J Moore, MD, PhD, Principal Investigator, Affiliation: Wayne State University

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.

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Primary outcome: Brain myo-inositol levels

Secondary outcome:

Signal transduction pathway measures

Gene expression levels

Brain volume

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.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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)

Wayne State University School of Medicine, Detroit, Michigan 48201, United States

Starting date: March 1996
Last updated: March 25, 2009