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Completed

NCT Number: NCT00870311

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

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.

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Key information

Conditions

Bipolar Disorder Alzheimer Disease Bipolar and Related Disorders Brain Diseases Central Nervous System Diseases Dementia Familial paroxysmal dystonia Mental Disorders Mood Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Wayne State University School of Medicine

Detroit, Michigan, 48201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Lithium Carbonate

Drug

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

Primary outcomes

  1. Brain myo-inositol levels

    Time frame: 4 weeks

Secondary outcomes

  1. Signal transduction pathway measures

    Time frame: 4 weeks

  2. Gene expression levels

    Time frame: 4 weeks

  3. Brain volume

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Wayne State University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
1996
Primary completion
2004
Study completion
2004
First posted
Mar 27, 2009
Registry last updated
Mar 27, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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