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Brain Ion Homeostasis, Lithium and Bipolar Disorder

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NYU Langone Health

Status

Terminated

Conditions

Healthy
Bipolar Disorder

Study type

Observational

Funder types

Other

Identifiers

NCT02727127
12-03629

Details and patient eligibility

About

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.

Full 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.

Enrollment

26 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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).

Trial design

26 participants in 2 patient groups

Healthy Volunteers
Description:
MRI on 3 Tesla (3T) or 7 Tesla (7T) scanner, without contrast
Bipolar Patients
Description:
MRI on 3 Tesla (3T) or 7 Tesla (7T) scanner, without contrast

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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