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NCT02727127 Clinical Trial

Brain Ion Homeostasis, Lithium and Bipolar Disorder

Healthy Clinical Trial

Official title:
Brain Ion Homeostasis, Lithium and Bipolar Disorder

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02727127
Other study ID # 12-03629
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date September 2015
Est. completion date September 11, 2019

Study information
Verified date July 2020
Source NYU Langone Health
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 26
Est. completion date September 11, 2019
Est. primary completion date September 11, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility 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).

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States New York University School of Medicine New York New York

Sponsors (1)
Lead Sponsor Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
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