NCT02727127

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 4, 2016

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 11, 2019

Completed
Last Updated

July 24, 2020

Status Verified

July 1, 2020

Enrollment Period

4 years

First QC Date

March 29, 2016

Last Update Submit

July 22, 2020

Conditions

HealthyBipolar Disorder

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • 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

Study Arms (2)

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

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Residents of New York City and surrounding areas

You may qualify if:

  • 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)

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Study Officials

  • Fernando Boada, PhD

    New York University Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2016

First Posted

April 4, 2016

Study Start

September 1, 2015

Primary Completion

September 11, 2019

Study Completion

September 11, 2019

Last Updated

July 24, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)