Brain Ion Homeostasis, Lithium and Bipolar Disorder

Terminated

• Conditions: Bipolar Disorder; Healthy

• Registration Number: NCT02727127
• Lead Sponsor: NYU Langone Health

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.

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 Timeline

• Study Start: 2015-09
• Study First Submitted: 2016-03-29
• Study First Submitted QC: 2016-03-29
• Study First Posted: 2016-04-04
• Primary Completion: 2019-09-11
• Study Completion: 2019-09-11
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-22
• Last Update Posted: 2020-07-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 26

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)

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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).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States