Brain Ion Homeostasis, Lithium and Bipolar Disorder | NCT02727127

Studies
Brain Ion Homeostasis, Lithium and Bipolar Disorder

NCT02727127

Sponsor

NYU Langone Health

Status

Terminated

Last Update Posted

Jul 24, 2020Actual

Enrollment

26Actual

Phase

Not provided

Conditions

Healthy
Bipolar Disorder

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lost funding due to low enrollment

Expanded Access Info

Start Date

Sep 2015

Primary Completion Date

Sep 11, 2019Actual

Completion Date

Sep 11, 2019Actual

First Submitted Date

Mar 29, 2016

First Submission Date that Met QC Criteria

Mar 29, 2016

First Posted Date

Apr 4, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 22, 2020

Last Update Posted Date

Jul 24, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

26Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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).

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Residents of New York City and surrounding areas

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Fernando Boada, PhD	New York University Medical School	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
New York University School of Medicine		New York	New York	10016	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001714	Bipolar Disorder

Ancestor Terms

ID	Term
D000068105	Bipolar and Related Disorders
D019964	Mood Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided