Neural Correlates for Therapeutic Mechanisms of Lithium in Bipolar Disorder

NCT ID: NCT01543724

Last Updated: 2018-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-01

Study Completion Date

2017-12-31

Brief Summary

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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

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Conditions

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Bipolar Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Lithium

Group Type EXPERIMENTAL

Lithium

Intervention Type DRUG

10mg/kg/day for 12 weeks

Interventions

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Lithium

10mg/kg/day for 12 weeks

Intervention Type DRUG

Eligibility Criteria

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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.)
Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Soon Chun Hyang University

OTHER

Sponsor Role collaborator

Ewha Womans University

OTHER

Sponsor Role lead

Responsible Party

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In Kyoon Lyoo

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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bpli2008

Identifier Type: -

Identifier Source: org_study_id

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