Brain Ion Homeostasis, Lithium and Bipolar Disorder

NCT ID: NCT02727127

Last Updated: 2020-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2019-09-11

Brief Summary

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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

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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.

Conditions

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Healthy Bipolar Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy Volunteers

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

No interventions assigned to this group

Bipolar Patients

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

No interventions assigned to this group

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fernando Boada, PhD

Role: PRINCIPAL_INVESTIGATOR

New York University Medical School

Locations

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New York University School of Medicine

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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12-03629

Identifier Type: -

Identifier Source: org_study_id

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