Neural Correlates for Therapeutic Mechanisms of Lithium in Bipolar Disorder

Ewha Womans University

Status and phase: Withdrawn; Phase 4

Conditions: Bipolar Disorder

Treatments: Drug: Lithium

Study type: Interventional

Funder types: Other

Identifiers

NCT01543724

bpli2008

Details and patient eligibility

About

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.

Sex: All

Ages: 19 to 55 years old

Volunteers: No 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.)

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Lithium

Experimental group

Treatment:

Drug: Lithium