Neural Correlates for Therapeutic Mechanisms of Lithium in Bipolar Disorder

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

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01543724

Enrollment

Registered

2012-03-05

Start date

2015-06-01

Completion date

2017-12-31

Last updated

2018-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder

Keywords

Lithium, Bipolar disorder, Multimodal Brain Imaging

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.

Interventions

DRUGLithium

10mg/kg/day for 12 weeks

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 55 Years

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.)

Design outcomes

Primary

Measure	Time frame
Change from baseline in global function scores at 1 week	Baseline and at 1 week
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 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

Secondary

Measure	Time frame
Number of participants with adverse events	12 weeks
Changes from baseline in brain structure analyzed using computational approach	Baseline and at 12 weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026