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

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Wayne State University

Status and phase

Completed
Phase 4

Conditions

Bipolar Disorder

Treatments

Drug: Lithium Carbonate

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00870311
H12-48-95
NIMH (MH159107)

Details and patient eligibility

About

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.

Full 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.

Enrollment

28 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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)

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

28 participants in 1 patient group

Blinded Lithium
Experimental group
Description:
Bipolar Disorder patients
Treatment:
Drug: Lithium Carbonate

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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