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NCT02827045 Clinical Trial

Study of a Vestibular Biomarker of Phase in Bipolar Disorder

Bipolar Disorder Clinical Trial

— BDmarker  

Official title:
Exploratory Study of a Vestibular Biomarker of Phase in Bipolar Disorder

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT02827045
Other study ID # VESTBRAIN002
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date July 2016
Est. completion date October 2022

Study information
Verified date May 2022
Source Vest Brain,Centro de Estudios Neurovestibulares
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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).

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 24
Est. completion date October 2022
Est. primary completion date July 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• Vestibular test

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Vest Brain,Centro de Estudios Neurovestibulares

Outcome
Type Measure Description Time frame Safety issue
Primary Vestibular test December 2017
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