Neural Correlates for Therapeutic Mechanisms of Lithium in Bipolar Disorder

Sponsor

Ewha Womans University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01543724

Collaborator

Soon Chun Hyang University (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Bipolar Disorder	Drug: Lithium	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2015

Anticipated Primary Completion Date :

Dec 31, 2017

Anticipated Study Completion Date :

Dec 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lithium	Drug: Lithium 10mg/kg/day for 12 weeks

Arm

Intervention/Treatment

Experimental: Lithium

Drug: Lithium

10mg/kg/day for 12 weeks

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.)