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

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ClinicalTrials.gov Identifier: NCT02827045
Recruitment Status : Unknown
Verified July 2016 by Ana Maria Soza Ried, Vest Brain,Centro de Estudios Neurovestibulares.
Recruitment status was:  Enrolling by invitation
First Posted : July 11, 2016
Last Update Posted : July 11, 2016
Sponsor:
Information provided by (Responsible Party):
Ana Maria Soza Ried, Vest Brain,Centro de Estudios Neurovestibulares

Brief 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).

Condition or disease Intervention/treatment
Bipolar Disorder Depression, Bipolar Device: Vestibular test

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Study Type : Observational
Estimated Enrollment : 24 participants
Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Official Title: Exploratory Study of a Vestibular Biomarker of Phase in Bipolar Disorder
Study Start Date : July 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

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



Primary Outcome Measures :
  1. Vestibular test [ Time Frame: December 2017 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
study population come from psychiatric care consults
Criteria

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
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Responsible Party: Ana Maria Soza Ried, Dr., Vest Brain,Centro de Estudios Neurovestibulares
ClinicalTrials.gov Identifier: NCT02827045    
Other Study ID Numbers: VESTBRAIN002
First Posted: July 11, 2016    Key Record Dates
Last Update Posted: July 11, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders