Study of the Effectiveness of Vestibular Stimulation as a Coadjuvant Treatment in Major Depression

This study has been completed.

Sponsor:

Collaborator:

Pontificia Universidad Catolica de Chile

Information provided by (Responsible Party):

Ana Maria Soza Ried, Fuerza Aérea de Chile

ClinicalTrials.gov Identifier:

NCT01399671

First received: July 12, 2011

Last updated: March 2, 2012

Last verified: March 2011

History of Changes

Purpose

Major depression is characterized by vestibular anomalies. The investigators hypothesized that vestibular stimulation will improve depression symptoms in major depression patients.

Condition	Intervention
Depression Major Depression Vestibular Disorders	Other: vestibular stimulation


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Clinical Randomized Trial to Evaluate the Efficacy of Vestibular Stimulation as Coadjuvant Therapy in Major Depression

Further study details as provided by Fuerza Aérea de Chile:

Primary Outcome Measures:

Hamilton depression rating score [ Time Frame: 1 month after the treatment start ] [ Designated as safety issue: Yes ]


Enrollment:	80
Study Start Date:	March 2011
Study Completion Date:	January 2012
Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Intervention Details:

vestibular stimulation

Eligibility


Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

major depression patients,
actual Hamilton score > 14

Exclusion Criteria:

pregnant,
neurological disorders,
epilepsy,
bipolar disorder,
schizophrenia,
anorexia,
bulimia.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01399671

Locations


Chile
Centro de Medicina Aeroespacial
Santiago, Región Metropolitana, Chile

Sponsors and Collaborators

Fuerza Aérea de Chile

Pontificia Universidad Catolica de Chile

Investigators


Principal Investigator:	Ana M Soza, MD	Fuerza Aerea de Chile

More Information


Responsible Party:	Ana Maria Soza Ried, Dr, Fuerza Aérea de Chile
ClinicalTrials.gov Identifier:	NCT01399671 History of Changes
Other Study ID Numbers:	SA10I220044
Study First Received:	July 12, 2011
Last Updated:	March 2, 2012
Health Authority:	Chile: Comisión Nacional de Investigación Científica y Tecnológica

Keywords provided by Fuerza Aérea de Chile:


depression vestibular

Additional relevant MeSH terms:


Depression Depressive Disorder Depressive Disorder, Major Vestibular Diseases Behavioral Symptoms	Mood Disorders Mental Disorders Labyrinth Diseases Ear Diseases Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on September 30, 2016

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