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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03421847
Other study ID # ROTDEPR01
Secondary ID
Status Completed
Phase N/A
First received January 29, 2018
Last updated February 2, 2018
Start date July 1, 2005
Est. completion date December 15, 2006

Study information

Verified date February 2018
Source Vest Brain,Centro de Estudios Neurovestibulares
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date December 15, 2006
Est. primary completion date December 15, 2006
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Vest Brain,Centro de Estudios Neurovestibulares Centro de Medicina Aeroespacial.

Outcome

Type Measure Description Time frame Safety issue
Primary Vestibular Activity 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. Vestibular rotatory test for each participant is about 50- 60 minutes. One rotatory test per participant.
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