Neural Correlates for Therapeutic Mechanisms of Lithium in Bipolar Disorder
This study is currently recruiting participants.
Verified February 2012 by Seoul National University Hospital
Sponsor:
Seoul National University Hospital
Information provided by (Responsible Party):
In Kyoon Lyoo, MD, PhD, MMS, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01543724
First received: February 28, 2012
Last updated: March 2, 2012
Last verified: February 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Bipolar Disorder |
Drug: Lithium |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | A Brain Imaging Study to Investigate Neural Correlates for Therapeutic Mechanisms of Lithium in Bipolar Disorder: Glycogen Synthase Kinase 3β Polymorphism (-50T/C) and Gray Matter Volume Increase Following Lithium Treatment in Bipolar Disorder |
Resource links provided by NLM:
Further study details as provided by Seoul National University Hospital:
Primary Outcome Measures:
- Change from baseline in manic symptom scores at 12 weeks [ Time Frame: Baseline and at 12 weeks ] [ Designated as safety issue: No ]
- Change from baseline in manic symptom scores at 8 weeks [ Time Frame: Baseline and at 8 weeks ] [ Designated as safety issue: No ]
- Change from baseline in manic symptom scores at 4 weeks [ Time Frame: Baseline and at 4 weeks ] [ Designated as safety issue: No ]
- Change from baseline in manic symptom scores at 1 week [ Time Frame: Baseline and at 1 week ] [ Designated as safety issue: No ]
- Change from baseline in depressive symptom scores at 12 weeks [ Time Frame: Baseline and at 12 weeks ] [ Designated as safety issue: No ]
- Change from baseline in depressive symptom scores at 8 weeks [ Time Frame: Baseline and at 8 weeks ] [ Designated as safety issue: No ]
- Change from baseline in depressive symptom scores at 4 weeks [ Time Frame: Baseline and at 4 weeks ] [ Designated as safety issue: No ]
- Change from baseline in depressive symptom scores at 1 week [ Time Frame: Baseline and at 1 week ] [ Designated as safety issue: No ]
- Change from baseline in global function scores at 12 weeks [ Time Frame: Baseline and at 12 weeks ] [ Designated as safety issue: No ]
- Change from baseline in global function scores at 8 weeks [ Time Frame: Baseline and at 8 weeks ] [ Designated as safety issue: No ]
- Change from baseline in global function scores at 4 weeks [ Time Frame: Baseline and at 4 weeks ] [ Designated as safety issue: No ]
- Change from baseline in global function scores at 1 week [ Time Frame: Baseline and at 1 week ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Changes from baseline in brain structure analyzed using computational approach [ Time Frame: Baseline and at 12 weeks ] [ Designated as safety issue: No ]
- Number of participants with adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- Number of participants with adverse events [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
- Number of participants with adverse events [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
- Number of participants with adverse events [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 50 |
| Study Start Date: | August 2008 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Lithium |
Drug: Lithium
10mg/kg/day for 12 weeks
|
Eligibility| Ages Eligible for Study: | 19 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01543724
Contacts
| Contact: Junghyun H Lee, MD, MS | 82-10-3453-1744 | leejunghyun1@gmail.com |
Locations
| Korea, Republic of | |
| Seoul National University Hospital | Recruiting |
| Seoul, Korea, Republic of, 110-744 | |
| Contact: Jeong-Hwa Hong, MD 82-2-740-8096 jhhong@snu.ac.kr | |
| Principal Investigator: In Kyoon Lyoo, MD, PhD, MMS | |
| Sub-Investigator: Jaeuk Hwang, MD, PhD | |
Sponsors and Collaborators
Seoul National University Hospital
More Information
No publications provided
| Responsible Party: | In Kyoon Lyoo, MD, PhD, MMS, Professor, Seoul National University Hospital |
| ClinicalTrials.gov Identifier: | NCT01543724 History of Changes |
| Other Study ID Numbers: | bpli2008 |
| Study First Received: | February 28, 2012 |
| Last Updated: | March 2, 2012 |
| Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
Additional relevant MeSH terms:
|
Bipolar Disorder Affective Disorders, Psychotic Mood Disorders Mental Disorders Lithium Lithium Carbonate Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Antimanic Agents Antidepressive Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013