Back to resultsNeural Correlates for Therapeutic Mechanisms of Lithium in Bipolar Disorder
Primary Purpose
Bipolar Disorder
Status
Withdrawn
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Lithium
Sponsored by
About this trial
This is an interventional basic science trial for Bipolar Disorder focused on measuring Lithium, Bipolar disorder, Multimodal Brain Imaging
Eligibility Criteria
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.)
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lithium
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline in manic symptom scores at 12 weeks
Change from baseline in manic symptom scores at 8 weeks
Change from baseline in manic symptom scores at 4 weeks
Change from baseline in manic symptom scores at 1 week
Change from baseline in depressive symptom scores at 12 weeks
Change from baseline in depressive symptom scores at 8 weeks
Change from baseline in depressive symptom scores at 4 weeks
Change from baseline in depressive symptom scores at 1 week
Change from baseline in global function scores at 12 weeks
Change from baseline in global function scores at 8 weeks
Change from baseline in global function scores at 4 weeks
Change from baseline in global function scores at 1 week
Secondary Outcome Measures
Changes from baseline in brain structure analyzed using computational approach
Number of participants with adverse events
Number of participants with adverse events
Number of participants with adverse events
Number of participants with adverse events
Full Information
NCT ID
NCT01543724
First Posted
February 28, 2012
Last Updated
February 8, 2018
Sponsor
Ewha Womans University
Collaborators
Soon Chun Hyang University
1. Study Identification
Unique Protocol Identification Number
NCT01543724
Brief Title
Neural Correlates for Therapeutic Mechanisms of Lithium in Bipolar Disorder
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Withdrawn
Why Stopped
The research project has been cancelled before any participants were enrolled.
Study Start Date
June 1, 2015 (Anticipated)
Primary Completion Date
December 31, 2017 (Anticipated)
Study Completion Date
December 31, 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ewha Womans University
Collaborators
Soon Chun Hyang University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
Lithium, Bipolar disorder, Multimodal Brain Imaging
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lithium
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Lithium
Intervention Description
10mg/kg/day for 12 weeks
Primary Outcome Measure Information:
Title
Change from baseline in manic symptom scores at 12 weeks
Time Frame
Baseline and at 12 weeks
Title
Change from baseline in manic symptom scores at 8 weeks
Time Frame
Baseline and at 8 weeks
Title
Change from baseline in manic symptom scores at 4 weeks
Time Frame
Baseline and at 4 weeks
Title
Change from baseline in manic symptom scores at 1 week
Time Frame
Baseline and at 1 week
Title
Change from baseline in depressive symptom scores at 12 weeks
Time Frame
Baseline and at 12 weeks
Title
Change from baseline in depressive symptom scores at 8 weeks
Time Frame
Baseline and at 8 weeks
Title
Change from baseline in depressive symptom scores at 4 weeks
Time Frame
Baseline and at 4 weeks
Title
Change from baseline in depressive symptom scores at 1 week
Time Frame
Baseline and at 1 week
Title
Change from baseline in global function scores at 12 weeks
Time Frame
Baseline and at 12 weeks
Title
Change from baseline in global function scores at 8 weeks
Time Frame
Baseline and at 8 weeks
Title
Change from baseline in global function scores at 4 weeks
Time Frame
Baseline and at 4 weeks
Title
Change from baseline in global function scores at 1 week
Time Frame
Baseline and at 1 week
Secondary Outcome Measure Information:
Title
Changes from baseline in brain structure analyzed using computational approach
Time Frame
Baseline and at 12 weeks
Title
Number of participants with adverse events
Time Frame
12 weeks
Title
Number of participants with adverse events
Time Frame
8 weeks
Title
Number of participants with adverse events
Time Frame
4 weeks
Title
Number of participants with adverse events
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.)
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Neural Correlates for Therapeutic Mechanisms of Lithium in Bipolar Disorder
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