Neural Correlates for Therapeutic Mechanisms of Lithium in Bipolar Disorder

Phase 4

Withdrawn

• Conditions: Bipolar Disorder
• Interventions: Drug: Lithium

• Registration Number: NCT01543724
• Lead Sponsor: Ewha Womans University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-28
• Study First Submitted QC: 2012-03-02
• Study First Posted: 2012-03-05
• Study Start: 2015-06-01
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-08
• Last Update Posted: 2018-02-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lithium	Lithium	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Changes from baseline in brain structure analyzed using computational approach	Baseline and at 12 weeks
Number of participants with adverse events	1 week

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of