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Brain Ion Homeostasis, Lithium and Bipolar Disorder

Sponsor
NYU Langone Health (Other)
Overall Status
Terminated
CT.gov ID
NCT02727127
Collaborator
(none)
26
Enrollment
1
Location
48.3
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In this project, investigators intend to carry out the first simultaneous, in vivo, imaging study of lithium content and sodium ion homeostasis in the brain of Bipolar Disorder (BPD) patients under Lithium therapy.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The purpose of this study is to validate a new method for the measurement of the amount of lithium (also known as lithium concentration) in the brain of subjects undergoing lithium treatment for bipolar disorder. The method involves the use of Magnetic Resonance Imaging (MRI) and Spectroscopy (MRS) techniques. These are non-invasive techniques, with no known harmful effects, that allow investigators to measure the amount of lithium in an individual's brain. There will be no contrast dye used in this study.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    26 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Brain Ion Homeostasis, Lithium and Bipolar Disorder
    Study Start Date :
    Sep 1, 2015
    Actual Primary Completion Date :
    Sep 11, 2019
    Actual Study Completion Date :
    Sep 11, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    Healthy Volunteers

    MRI on 3 Tesla (3T) or 7 Tesla (7T) scanner, without contrast
    Bipolar Patients

    MRI on 3 Tesla (3T) or 7 Tesla (7T) scanner, without contrast

    Outcome Measures

    Primary Outcome Measures

    1. Study the relationship between BLC and brain sodium ion homeostasis, as measured by concurrent Single / Triple quantum sodium MRI in BPD patients [1 Hour]

    Secondary Outcome Measures

    1. To investigate the measurement of sodium ion homeostasis in the brain of BPD patients, at clinical magnetic field strengths (3 Tesla), as a non-invasive surrogate marker of BLC during Lithium Carbonate therapy [1 Hour]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Psychiatrically stable patients (diagnosed according to the Diagnostic and Statistical Manual, DSM-IV, criteria)

    • On steady state serum lithium levels (0.8-1.2mEq/L)

    Exclusion Criteria:

    • Subjects who have a history of head trauma

    • Subjects who have a contraindication for an MRI exam, including a claustrophobia, surgical or vascular implants, pregnancy, pacemakers, neurostimulators, history of metal in the eyes, and orthodontia or extensive bridgework (with have a particular impact on gradient echo imaging).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 New York University School of Medicine New York New York United States 10016

    Sponsors and Collaborators

    • NYU Langone Health

    Investigators

    • Principal Investigator: Fernando Boada, PhD, New York University Medical School

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    NYU Langone Health
    ClinicalTrials.gov Identifier:
    NCT02727127
    Other Study ID Numbers:
    • 12-03629
    First Posted:
    Apr 4, 2016
    Last Update Posted:
    Jul 24, 2020
    Last Verified:
    Jul 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Bipolar Disorder

    Study Results

    No Results Posted as of Jul 24, 2020