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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Bipolar Disorder

Intervention / Treatment
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* Drug: Lithium Carbonate


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blinded Lithium<br>Bipolar Disorder patients | Drug: Lithium Carbonate<br>* 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.<br>* Other names: Lithobid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain myo-inositol levels |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Signal transduction pathway measures |  | 4 weeks | 
| Gene expression levels |  | 4 weeks | 
| Brain volume |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pkc, Lithium, Neuroprotection, Neurotrophic, bcl2, gsk3, MRI, myoinositol, MRS, Alzheimers Disease