Neural Correlates for Therapeutic Mechanisms of Lithium in Bipolar Disorder

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01543724
• Other study ID #: bpli2008
• Status: Withdrawn
• Phase: Phase 4
• First received: February 28, 2012
• Last updated: February 8, 2018
• Start date: June 1, 2015
• Est. completion date: December 31, 2017

Study information

• Verified date: February 2018
• Source: Ewha Womans University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 55 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease

Intervention

Drug:
• Lithium
10mg/kg/day for 12 weeks

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Ewha Womans University	Soon Chun Hyang University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in manic symptom scores at 12 weeks		Baseline and at 12 weeks
Primary	Change from baseline in manic symptom scores at 8 weeks		Baseline and at 8 weeks
Primary	Change from baseline in manic symptom scores at 4 weeks		Baseline and at 4 weeks
Primary	Change from baseline in manic symptom scores at 1 week		Baseline and at 1 week
Primary	Change from baseline in depressive symptom scores at 12 weeks		Baseline and at 12 weeks
Primary	Change from baseline in depressive symptom scores at 8 weeks		Baseline and at 8 weeks
Primary	Change from baseline in depressive symptom scores at 4 weeks		Baseline and at 4 weeks
Primary	Change from baseline in depressive symptom scores at 1 week		Baseline and at 1 week
Primary	Change from baseline in global function scores at 12 weeks		Baseline and at 12 weeks
Primary	Change from baseline in global function scores at 8 weeks		Baseline and at 8 weeks
Primary	Change from baseline in global function scores at 4 weeks		Baseline and at 4 weeks
Primary	Change from baseline in global function scores at 1 week		Baseline and at 1 week
Secondary	Changes from baseline in brain structure analyzed using computational approach		Baseline and at 12 weeks
Secondary	Number of participants with adverse events		12 weeks
Secondary	Number of participants with adverse events		8 weeks
Secondary	Number of participants with adverse events		4 weeks
Secondary	Number of participants with adverse events		1 week