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

Sponsor
Vest Brain,Centro de Estudios Neurovestibulares (Other)
Overall Status
Completed
CT.gov ID
NCT03421847
Collaborator
Centro de Medicina Aeroespacial. (Other)
41
17.5

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Rotatory vestibular test

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.

Study Design

Study Type:
Observational
Actual Enrollment :
41 participants
Observational Model:
Case-Control
Time Perspective:
Other
Official Title:
Study of Rotatory Vestibular Tests in Major Depression Patients and Healthy Control Subjects.
Actual Study Start Date :
Jul 1, 2005
Actual Primary Completion Date :
Dec 15, 2006
Actual Study Completion Date :
Dec 15, 2006

Arms and Interventions

Arm Intervention/Treatment
Major Depression Group

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

Diagnostic Test: Rotatory vestibular test
We will measure Depression and Healthy subjects vestibular activity by Rotatory Vestibular tests

Healthy Control Group

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

Diagnostic Test: Rotatory vestibular test
We will measure Depression and Healthy subjects vestibular activity by Rotatory Vestibular tests

Outcome Measures

Primary Outcome Measures

  1. Vestibular Activity [Vestibular rotatory test for each participant is about 50- 60 minutes. One rotatory test per participant.]

    The primary outcome corresponds to the vestibular activity. The vestibular stimulation provided by the rotatory chair is sensed by the inner earĀ“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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 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.

Exclusion Criteria:
  • pregnant women

  • neurologic disorders.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Vest Brain,Centro de Estudios Neurovestibulares
  • Centro de Medicina Aeroespacial.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Vest Brain,Centro de Estudios Neurovestibulares
ClinicalTrials.gov Identifier:
NCT03421847
Other Study ID Numbers:
  • ROTDEPR01
First Posted:
Feb 5, 2018
Last Update Posted:
Feb 6, 2018
Last Verified:
Feb 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Vest Brain,Centro de Estudios Neurovestibulares
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 6, 2018