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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.
Sponsor:
Collaborator:
Information provided by:
Wayne State University
ClinicalTrials.gov Identifier:
NCT00870311
First received: March 25, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

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
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Signal transduction pathway measures [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Gene expression levels [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Brain volume [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00870311

Locations
United States, Michigan
Wayne State University School of Medicine
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Wayne State University
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
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Husseini K. Manji, MD, F.R.C.P.C., Wayne State University and National Institute of Mental Health
ClinicalTrials.gov 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
Health Authority: United States: Institutional Review Board

Keywords provided by Wayne State University:
Lithium
Neuroprotection
Neurotrophic
bcl2
gsk3
pkc
MRI
myoinositol
MRS
Alzheimers Disease

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mental Disorders
Mood Disorders
Lithium
Lithium Carbonate
Antidepressive Agents
Antimanic Agents
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 27, 2014