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

February 2, 2018 updated by: Vest Brain,Centro de Estudios Neurovestibulares
This study evaluates the vestibular activity in major depression patients and healthy controls using the rotatory test and electronystagmography.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

41

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vestibular Activity
Time Frame: 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 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vest Brain,Centro de Estudios Neurovestibulares

Collaborators

Centro de Medicina Aeroespacial.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2005

Primary Completion (ACTUAL)

December 15, 2006

Study Completion (ACTUAL)

December 15, 2006

Study Registration Dates

First Submitted

January 29, 2018

First Submitted That Met QC Criteria

January 29, 2018

First Posted (ACTUAL)

February 5, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 6, 2018

Last Update Submitted That Met QC Criteria

February 2, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ROTDEPR01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We plan to share all collected vestibular data of IPD after 6 months of publication.

IPD Sharing Time Frame

Data will be available after 6 months of publication undefined.

IPD Sharing Supporting Information Type

  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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