Neural Correlates for Therapeutic Mechanisms of Lithium in Bipolar Disorder

Study Overview
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Brief Summary
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The investigators will assess Li-induced gray matter volume changes with regard to the endophenotype of GSK3beta polymorphism. The changes of gray matter are supposed to be more attributable to neurotrophic and neuroprotective characteristics of Li, which were closely related to the inhibition of apoptotic activity of GSK3beta.

Official Title
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A Multimodal Brain Imaging Study to Investigate Neural Correlates for Therapeutic Mechanisms of Lithium in Bipolar Disorder: Glycogen Synthase Kinase 3β Single Nucleotide Polymorphisms and Gray Matter Volume Increase Following Lithium Treatment in Bipolar Disorder

Conditions
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Bipolar Disorder

Intervention / Treatment
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* Drug: Lithium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and Women aged between 19 and 55 Diagnosis of bipolar I disorder as assessed by the structured clinical interview for DSM-IV (SCID-IV) Patients who have not used psychoactive medications for more than 2 weeks Individuals who provided written consent for participation Exclusion Criteria: Presence of any major physical or neurological illness (e.g., head trauma, epilepsy, seizure, stroke, cerebral tumor, multiple sclerosis, cerebrovascular disease, narrow-angle glaucoma, drug hypersensitivity, etc.) Women who are pregnant, breastfeeding, or planning pregnancy Diagnosis of any Axis I disorder other than bipolar disorder Intelligence quotient below 80 Current or past drug abuse Contraindications to magnetic resonance imaging (e.g., pacemaker implantation, claustrophobia, etc.)

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lithium<br> | Drug: Lithium<br>* 10mg/kg/day for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in manic symptom scores at 12 weeks |  | Baseline and at 12 weeks | 
| Change from baseline in manic symptom scores at 8 weeks |  | Baseline and at 8 weeks | 
| Change from baseline in manic symptom scores at 4 weeks |  | Baseline and at 4 weeks | 
| Change from baseline in manic symptom scores at 1 week |  | Baseline and at 1 week | 
| Change from baseline in depressive symptom scores at 12 weeks |  | Baseline and at 12 weeks | 
| Change from baseline in depressive symptom scores at 8 weeks |  | Baseline and at 8 weeks | 
| Change from baseline in depressive symptom scores at 4 weeks |  | Baseline and at 4 weeks | 
| Change from baseline in depressive symptom scores at 1 week |  | Baseline and at 1 week | 
| Change from baseline in global function scores at 12 weeks |  | Baseline and at 12 weeks | 
| Change from baseline in global function scores at 8 weeks |  | Baseline and at 8 weeks | 
| Change from baseline in global function scores at 4 weeks |  | Baseline and at 4 weeks | 
| Change from baseline in global function scores at 1 week |  | Baseline and at 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in brain structure analyzed using computational approach |  | Baseline and at 12 weeks | 
| Number of participants with adverse events |  | 12 weeks | 
| Number of participants with adverse events |  | 8 weeks | 
| Number of participants with adverse events |  | 4 weeks | 
| Number of participants with adverse events |  | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lithium, Bipolar disorder, Multimodal Brain Imaging