NCT02827045

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).

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2016

Longer than P75 for all trials

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

July 6, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

May 7, 2024

Status Verified

May 1, 2024

Enrollment Period

8 years

First QC Date

July 6, 2016

Last Update Submit

May 6, 2024

Conditions

Bipolar DisorderDepression, Bipolar

Outcome Measures

Primary Outcomes (1)

  • Vestibular test

    December 2017

Study Arms (4)

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

Interventions

Vestibular testDEVICE
Depressive phaseEuthimic phaseHealthy subjectManiac phase

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

study population come from psychiatric care consults

You may qualify if:

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

You may not qualify if:

  • drugs addiction
  • alcohol addiction
  • neurologic condition, disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Vestibular Function Tests

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, OtologicalDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

July 6, 2016

First Posted

July 11, 2016

Study Start

July 1, 2016

Primary Completion

July 1, 2024

Study Completion

October 1, 2024

Last Updated

May 7, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share