Study of a Vestibular Biomarker of Phase in Bipolar Disorder (BDmarker)

May 6, 2024 updated by: Ana Maria Soza Ried, Vest Brain,Centro de Estudios Neurovestibulares

Exploratory Study of a Vestibular Biomarker of Phase in Bipolar Disorder

Bipolar Disorder show cyclic changes of mood between depression (depressive phase) and mania (maniac phase). Vestibular tests have been shown high sensibility and specificity as a biological marker for major depression. This exploratory investigation will measure and compare the vestibular activity of bipolar disorder patients during different phases ( 6 depressed phase, 6 maniac phase, 6 euthimic and 6 control healthy subjects).

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

24

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

study population come from psychiatric care consults

Description

Inclusion Criteria:

  • Bipolar disorder I or II
  • depressive phase of bipolar disorder
  • maniac phase of bipolar disorder
  • euthimic phase of bipolar disorder

Exclusion Criteria:

  • drugs addiction
  • alcohol addiction
  • neurologic condition, disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Crossover
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Depressive phase
Vestibular test
Device: Vestibular test
Maniac phase
Vestibular test
Device: Vestibular test
Euthimic phase
Vestibular test
Device: Vestibular test
Healthy subject
Vestibular test
Device: Vestibular test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Vestibular test
Time Frame: December 2017
December 2017

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vest Brain,Centro de Estudios Neurovestibulares

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

July 6, 2016

First Submitted That Met QC Criteria

July 7, 2016

First Posted (Estimated)

July 11, 2016

Study Record Updates

Last Update Posted (Actual)

May 7, 2024

Last Update Submitted That Met QC Criteria

May 6, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VESTBRAIN002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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