Study of a Vestibular Biomarker of Phase in Bipolar Disorder

NCT ID: NCT02827045

Last Updated: 2024-05-07

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

ENROLLING_BY_INVITATION

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-31

Study Completion Date

2024-10-31

Brief Summary

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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).

Detailed Description

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Conditions

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Bipolar Disorder Depression, Bipolar

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Depressive phase

Vestibular test

Vestibular test

Intervention Type DEVICE

Maniac phase

Vestibular test

Vestibular test

Intervention Type DEVICE

Euthimic phase

Vestibular test

Vestibular test

Intervention Type DEVICE

Healthy subject

Vestibular test

Vestibular test

Intervention Type DEVICE

Interventions

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Vestibular test

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vest Brain,Centro de Estudios Neurovestibulares

OTHER

Sponsor Role lead

Responsible Party

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Ana Maria Soza Ried

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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VESTBRAIN002

Identifier Type: -

Identifier Source: org_study_id

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