ClinicalTrials.gov
ClinicalTrials.gov Menu

Neural Correlates for Therapeutic Mechanisms of Lithium in Bipolar Disorder

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.
ClinicalTrials.gov Identifier: NCT01543724
Recruitment Status : Withdrawn (The research project has been cancelled before any participants were enrolled.)
First Posted : March 5, 2012
Last Update Posted : February 9, 2018
Sponsor:
Collaborator:
Soon Chun Hyang University
Information provided by (Responsible Party):
In Kyoon Lyoo, Ewha Womans University

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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Drug: Lithium Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Estimated Study Start Date : June 1, 2015
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Lithium Drug: Lithium
10mg/kg/day for 12 weeks



Primary Outcome Measures :
  1. Change from baseline in manic symptom scores at 12 weeks [ Time Frame: Baseline and at 12 weeks ]
  2. Change from baseline in manic symptom scores at 8 weeks [ Time Frame: Baseline and at 8 weeks ]
  3. Change from baseline in manic symptom scores at 4 weeks [ Time Frame: Baseline and at 4 weeks ]
  4. Change from baseline in manic symptom scores at 1 week [ Time Frame: Baseline and at 1 week ]
  5. Change from baseline in depressive symptom scores at 12 weeks [ Time Frame: Baseline and at 12 weeks ]
  6. Change from baseline in depressive symptom scores at 8 weeks [ Time Frame: Baseline and at 8 weeks ]
  7. Change from baseline in depressive symptom scores at 4 weeks [ Time Frame: Baseline and at 4 weeks ]
  8. Change from baseline in depressive symptom scores at 1 week [ Time Frame: Baseline and at 1 week ]
  9. Change from baseline in global function scores at 12 weeks [ Time Frame: Baseline and at 12 weeks ]
  10. Change from baseline in global function scores at 8 weeks [ Time Frame: Baseline and at 8 weeks ]
  11. Change from baseline in global function scores at 4 weeks [ Time Frame: Baseline and at 4 weeks ]
  12. Change from baseline in global function scores at 1 week [ Time Frame: Baseline and at 1 week ]

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


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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.)

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


Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Ewha Womans University
Soon Chun Hyang University

Responsible Party: In Kyoon Lyoo, Professor, Ewha Womans University
ClinicalTrials.gov Identifier: NCT01543724     History of Changes
Other Study ID Numbers: bpli2008
First Posted: March 5, 2012    Key Record Dates
Last Update Posted: February 9, 2018
Last Verified: February 2018

Keywords provided by In Kyoon Lyoo, Ewha Womans University:
Lithium
Bipolar disorder
Multimodal Brain Imaging

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