NCT01543724

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2015

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 5, 2012

Completed
3.2 years until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

February 9, 2018

Status Verified

February 1, 2018

Enrollment Period

2.6 years

First QC Date

February 28, 2012

Last Update Submit

February 8, 2018

Conditions

Bipolar Disorder

Keywords

LithiumBipolar disorderMultimodal Brain Imaging

Outcome Measures

Primary Outcomes (12)

  • Change from baseline in manic symptom scores at 12 weeks

    Baseline and at 12 weeks

  • Change from baseline in manic symptom scores at 8 weeks

    Baseline and at 8 weeks

  • Change from baseline in manic symptom scores at 4 weeks

    Baseline and at 4 weeks

  • Change from baseline in manic symptom scores at 1 week

    Baseline and at 1 week

  • Change from baseline in depressive symptom scores at 12 weeks

    Baseline and at 12 weeks

  • Change from baseline in depressive symptom scores at 8 weeks

    Baseline and at 8 weeks

  • Change from baseline in depressive symptom scores at 4 weeks

    Baseline and at 4 weeks

  • Change from baseline in depressive symptom scores at 1 week

    Baseline and at 1 week

  • Change from baseline in global function scores at 12 weeks

    Baseline and at 12 weeks

  • Change from baseline in global function scores at 8 weeks

    Baseline and at 8 weeks

  • Change from baseline in global function scores at 4 weeks

    Baseline and at 4 weeks

  • Change from baseline in global function scores at 1 week

    Baseline and at 1 week

Secondary Outcomes (5)

  • Changes from baseline in brain structure analyzed using computational approach

    Baseline and at 12 weeks

  • Number of participants with adverse events

    12 weeks

  • Number of participants with adverse events

    8 weeks

  • Number of participants with adverse events

    4 weeks

  • Number of participants with adverse events

    1 week

Study Arms (1)

Lithium

EXPERIMENTAL
Drug: Lithium

Interventions

LithiumDRUG

10mg/kg/day for 12 weeks

Lithium

Eligibility Criteria

Age19 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Lithium

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Metals, AlkaliElementsInorganic ChemicalsMetals, LightMetals
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 28, 2012

First Posted

March 5, 2012

Study Start

June 1, 2015

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

February 9, 2018

Record last verified: 2018-02

Locations

KR(1)