Neural Correlates for Therapeutic Mechanisms of Lithium in Bipolar Disorder

Ewha Womans University

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Conditions

Bipolar Disorder

Interventions

LithiumDRUG

10mg/kg/day for 12 weeks

Eligibility

Sex: ALLMin age: 19 YearsMax age: 55 Years

Medical Language ↔ Plain English

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.)

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Change from baseline in manic symptom scores at 12 weeks

Time frame: Baseline and at 12 weeks

Change from baseline in manic symptom scores at 8 weeks

Time frame: Baseline and at 8 weeks

Change from baseline in manic symptom scores at 4 weeks

Time frame: Baseline and at 4 weeks

Change from baseline in manic symptom scores at 1 week

Time frame: Baseline and at 1 week

Change from baseline in depressive symptom scores at 12 weeks

Time frame: Baseline and at 12 weeks

Change from baseline in depressive symptom scores at 8 weeks

Time frame: Baseline and at 8 weeks

Change from baseline in depressive symptom scores at 4 weeks

Time frame: Baseline and at 4 weeks

Change from baseline in depressive symptom scores at 1 week

Time frame: Baseline and at 1 week

Change from baseline in global function scores at 12 weeks

Time frame: Baseline and at 12 weeks

Change from baseline in global function scores at 8 weeks

Time frame: Baseline and at 8 weeks

Change from baseline in global function scores at 4 weeks

Time frame: Baseline and at 4 weeks

Change from baseline in global function scores at 1 week

Data from ClinicalTrials.gov

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Neural Correlates for Therapeutic Mechanisms of Lithium in Bipolar Disorder

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes