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

NCT03421847 | Completed

• 1 other identifier: ROTDEPR01
• Study Type: observational
• Target: 41
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Depression; Vestibular Disorder

Keywords

depression; vestibular disorder; rotatory test; electronystagmography

Outcome Measures

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.

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

Study Arms (2)

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

Rotatory vestibular test DIAGNOSTIC_TEST

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

Healthy Control Group; Major Depression Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• male and females adults (18 years or older)
• met the Diagnosing and Statistical Manual of Mental Disorders (DSM-IV-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.

You may not qualify if:

• pregnant women
• neurologic disorders.

Sponsors & Collaborators

• Vest Brain,Centro de Estudios Neurovestibulares: lead
• Centro de Medicina Aeroespacial.: collaborator

MeSH Terms

Conditions

Depression; Vestibular Diseases

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2018
• First Posted: February 5, 2018
• Study Start: July 1, 2005
• Primary Completion: December 15, 2006
• Study Completion: December 15, 2006
• Last Updated: February 6, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: Data will be available after 6 months of publication undefined.