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

This study has been completed.
National Institute of Mental Health (NIMH)
Information provided by:
Wayne State University Identifier:
First received: March 25, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
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 Intervention Phase
Bipolar Disorder
Drug: Lithium Carbonate
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Participant)
Primary Purpose: Basic Science
Official Title: Investigation of Lithium on Signal Transduction, Gene Expression and Brain Myo-Inositol Levels in Manic Patients

Resource links provided by NLM:

Further study details as provided by Wayne State University:

Primary Outcome Measures:
  • Brain myo-inositol levels [ Time Frame: 4 weeks ]

Secondary Outcome Measures:
  • Signal transduction pathway measures [ Time Frame: 4 weeks ]
  • Gene expression levels [ Time Frame: 4 weeks ]
  • Brain volume [ Time Frame: 4 weeks ]

Enrollment: 28
Study Start Date: March 1996
Study Completion Date: April 2004
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00870311

United States, Michigan
Wayne State University School of Medicine
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Wayne State University
National Institute of Mental Health (NIMH)
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
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Husseini K. Manji, MD, F.R.C.P.C., Wayne State University and National Institute of Mental Health Identifier: NCT00870311     History of Changes
Other Study ID Numbers: H12-48-95
NIMH (MH159107)
Study First Received: March 25, 2009
Last Updated: March 25, 2009

Keywords provided by Wayne State University:
Alzheimers Disease

Additional relevant MeSH terms:
Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Lithium Carbonate
Antidepressive Agents
Psychotropic Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Vitamin B Complex
Growth Substances processed this record on April 28, 2017