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Neural Correlates for Therapeutic Mechanisms of Lithium in Bipolar Disorder

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2012 by In Kyoon Lyoo, MD, PhD, MMS, Seoul National University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01543724
First Posted: March 5, 2012
Last Update Posted: March 5, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
In Kyoon Lyoo, MD, PhD, MMS, Seoul National University Hospital
  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: Intervention Model: Single Group Assignment
Masking: None (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 In Kyoon Lyoo, MD, PhD, MMS, Seoul National University Hospital:

Primary Outcome Measures:
  • Change from baseline in manic symptom scores at 12 weeks [ Time Frame: Baseline and at 12 weeks ]
  • Change from baseline in manic symptom scores at 8 weeks [ Time Frame: Baseline and at 8 weeks ]
  • Change from baseline in manic symptom scores at 4 weeks [ Time Frame: Baseline and at 4 weeks ]
  • Change from baseline in manic symptom scores at 1 week [ Time Frame: Baseline and at 1 week ]
  • Change from baseline in depressive symptom scores at 12 weeks [ Time Frame: Baseline and at 12 weeks ]
  • Change from baseline in depressive symptom scores at 8 weeks [ Time Frame: Baseline and at 8 weeks ]
  • Change from baseline in depressive symptom scores at 4 weeks [ Time Frame: Baseline and at 4 weeks ]
  • Change from baseline in depressive symptom scores at 1 week [ Time Frame: Baseline and at 1 week ]
  • Change from baseline in global function scores at 12 weeks [ Time Frame: Baseline and at 12 weeks ]
  • Change from baseline in global function scores at 8 weeks [ Time Frame: Baseline and at 8 weeks ]
  • Change from baseline in global function scores at 4 weeks [ Time Frame: Baseline and at 4 weeks ]
  • Change from baseline in global function scores at 1 week [ Time Frame: Baseline and at 1 week ]

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: February 28, 2012
First Posted: March 5, 2012
Last Update Posted: March 5, 2012
Last Verified: February 2012

Additional relevant MeSH terms:
Disease
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Lithium Carbonate
Antidepressive Agents
Psychotropic Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs