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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00870311

Enrollment

Registered

2009-03-27

Start date

1996-03-31

Completion date

2004-04-30

Last updated

2009-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder

Keywords

Lithium, Neuroprotection, Neurotrophic, bcl2, gsk3, pkc, MRI, myoinositol, MRS, Alzheimers Disease

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.

Interventions

DRUGLithium 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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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)

Design outcomes

Primary

Measure	Time frame
Brain myo-inositol levels	4 weeks

Secondary

Measure	Time frame
Signal transduction pathway measures	4 weeks
Gene expression levels	4 weeks
Brain volume	4 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026