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CompletedNCT03421847Updated Feb 6, 2018

Study of Rotatory Vestibular Tests in Major Depression Patients and Healthy Control Subjects.

An observational study in Depression and Vestibular Disorder, sponsored by Vest Brain,Centro de Estudios Neurovestibulares. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-06.

Sponsored by Vest Brain,Centro de Estudios Neurovestibulares · Observational

Study type
Observational
Model
Case-control
Time perspective
Other
Enrollment
41
Ages
18 Years and older
Sex
All
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Study summary

This study evaluates the vestibular activity in major depression patients and healthy controls using the rotatory test and electronystagmography.

Read the detailed description

Previous studies showed abnormal vestibular activity in major depression patients using caloric vestibular tests. The present study investigates the vestibular response to vestibular rotatory tests in major depression subjects and healthy controls.

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Conditions studied

  • Depression
  • Vestibular Disorder

Keywords

  • depression
  • vestibular disorder
  • rotatory test
  • electronystagmography
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In context

Depression

8,582 studies on the registry are indexed under Depression; 1,723 are open to participants now.

This study's enrollment of 41 is below the median of 175 across 1,259 observational studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Vest Brain,Centro de Estudios Neurovestibulares is the lead sponsor of 3 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Depression Group patients were selected by psychiatrists from the ambulatory Mental Health consult of the Hospital; the Control Group included 20 healthy volunteers, composed by desk workers from the center.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • male and females adults (18 years or older)
  • met the Diagnosing and Statistical Manual of Mental Disorders (-R, American Psychiatric Association, 2000) criterion.
  • had a score of 12 or more in the Hamilton Rating Scale, 21 items for Depression.
  • with or without actual pharmacological treatment, except benzodiazepines that were suspended 24 hours before the rotary test when corresponding.

Exclusion criteria

Exclusion Criteria:

  • pregnant women
  • neurologic disorders.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

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Study design

Observational model
Case-control
Time perspective
Other
Enrollment
41 participants (actual)
Patient registry
No

Groups and cohorts

  • Major Depression Group

    We will measure the vestibular activity of Major depression patients with Rotatory Test and electronystagmography

    Diagnostic Test: Rotatory vestibular test

  • Healthy Control Group

    We will measure the vestibular activity of Healthy subjects with Rotatory Test and electronystagmography.

    Diagnostic Test: Rotatory vestibular test

Interventions

  • Diagnostic testRotatory vestibular test

    We will measure Depression and Healthy subjects vestibular activity by Rotatory Vestibular tests

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What researchers measure

Primary outcomes

  1. Vestibular Activity

    The primary outcome corresponds to the vestibular activity. The vestibular stimulation provided by the rotatory chair is sensed by the inner ear´s vestibular receptors and generates reflex ocular movements(Vestibulo Ocular Reflex) registrated by electronystagmography. The main outcome corresponds to the asymmetry of the vestibular activity between both ears.

    Time frame: Vestibular rotatory test for each participant is about 50- 60 minutes. One rotatory test per participant.

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Yes — We plan to share all collected vestibular data of IPD after 6 months of publication.

Supporting information: Analytic code

Time frame: Data will be available after 6 months of publication undefined.

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2005 to primary completion in Dec 2006, 17 months.

Of 460 non-industry observational studies under Depression, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 63. This study's 17 months is below that.

Counting every sponsor, half of 493 studies reached it within 32 months; a quarter within 13 and three quarters within 62.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 29, 2018
First posted
Feb 5, 2018
StartActual
Jul 1, 2005
Primary completionActual
Dec 15, 2006
CompletionActual
Dec 15, 2006
Last update
Feb 6, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 6, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03421847
Lead sponsor
Vest Brain,Centro de Estudios Neurovestibulares
Collaborators
Centro de Medicina Aeroespacial.
Responsible party
Sponsor
First posted
Feb 5, 2018
Start date
Jul 1, 2005
Primary completion
Dec 15, 2006
Completion
Dec 15, 2006
Last update
Feb 6, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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