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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date July 6, 2016
First Posted Date July 11, 2016
Last Update Posted Date July 11, 2016
Study Start Date July 2016
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 7, 2016)
Vestibular test [ Time Frame: December 2017 ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study of a Vestibular Biomarker of Phase in Bipolar Disorder
Official Title Exploratory Study of a Vestibular Biomarker of Phase in Bipolar Disorder
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).
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population study population come from psychiatric care consults
Condition
  • Bipolar Disorder
  • Depression, Bipolar
Intervention Device: Vestibular test
Study Groups/Cohorts
  • Depressive phase
    Vestibular test
    Intervention: Device: Vestibular test
  • Maniac phase
    Vestibular test
    Intervention: Device: Vestibular test
  • Euthimic phase
    Vestibular test
    Intervention: Device: Vestibular test
  • Healthy subject
    Vestibular test
    Intervention: Device: Vestibular test
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: July 7, 2016)
24
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2018
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02827045
Other Study ID Numbers VESTBRAIN002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Ana Maria Soza Ried, Vest Brain,Centro de Estudios Neurovestibulares
Study Sponsor Vest Brain,Centro de Estudios Neurovestibulares
Collaborators Not Provided
Investigators Not Provided
PRS Account Vest Brain,Centro de Estudios Neurovestibulares
Verification Date July 2016