Neural Correlates for Therapeutic Mechanisms of Lithium in Bipolar Disorder

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Seoul National University Hospital.
Recruitment status was  Recruiting
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014