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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01399671
Recruitment Status : Completed
First Posted : July 22, 2011
Last Update Posted : March 5, 2012
Pontificia Universidad Catolica de Chile
Information provided by (Responsible Party):
Ana Maria Soza Ried, Fuerza Aérea de Chile

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

Condition or disease Intervention/treatment
Depression Major Depression Vestibular Disorders Other: vestibular stimulation

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Randomized Trial to Evaluate the Efficacy of Vestibular Stimulation as Coadjuvant Therapy in Major Depression
Study Start Date : March 2011
Primary Completion Date : January 2012
Study Completion Date : January 2012

Intervention Details:
    Other: vestibular stimulation
    vestibular stimulation

Primary Outcome Measures :
  1. Hamilton depression rating score [ Time Frame: 1 month after the treatment start ]

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

Inclusion Criteria:

  • major depression patients,
  • actual Hamilton score > 14

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01399671

Centro de Medicina Aeroespacial
Santiago, Región Metropolitana, Chile
Sponsors and Collaborators
Fuerza Aérea de Chile
Pontificia Universidad Catolica de Chile
Principal Investigator: Ana M Soza, MD Fuerza Aerea de Chile

Responsible Party: Ana Maria Soza Ried, Dr, Fuerza Aérea de Chile Identifier: NCT01399671     History of Changes
Other Study ID Numbers: SA10I220044
First Posted: July 22, 2011    Key Record Dates
Last Update Posted: March 5, 2012
Last Verified: March 2011

Keywords provided by Ana Maria Soza Ried, Fuerza Aérea de Chile:

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Vestibular Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases