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

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.

Study Overview

• Status: Withdrawn
• Conditions: Bipolar Disorder
• Intervention / Treatment: Drug: Lithium

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Lithium	Drug: Lithium; 10mg/kg/day for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in depressive symptom scores at 4 weeks	Baseline and at 4 weeks
Change from baseline in depressive symptom scores at 8 weeks	Baseline and at 8 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 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

Outcome Measure	Time Frame
Number of participants with adverse events	12 weeks
Number of participants with adverse events	4 weeks
Number of participants with adverse events	8 weeks
Changes from baseline in brain structure analyzed using computational approach	Baseline and at 12 weeks
Number of participants with adverse events	1 week

Collaborators and Investigators

• Sponsor: Ewha Womans University
• Collaborators: Soon Chun Hyang University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2015
• Primary Completion (ANTICIPATED): December 31, 2017
• Study Completion (ANTICIPATED): December 31, 2017

Study Registration Dates

• First Submitted: February 28, 2012
• First Submitted That Met QC Criteria: March 2, 2012
• First Posted (ESTIMATE): March 5, 2012

Study Record Updates

• Last Update Posted (ACTUAL): February 9, 2018
• Last Update Submitted That Met QC Criteria: February 8, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Bipolar disorder; Lithium; Multimodal Brain Imaging
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Bipolar and Related Disorders; Disease; Bipolar Disorder; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Enzyme Inhibitors; Tranquilizing Agents; Psychotropic Drugs; Antidepressive Agents; Antimanic Agents; Lithium Carbonate
• Other Study ID Numbers: bpli2008