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
  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

Resource links provided by NLM:


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:
    Other: vestibular stimulation
    vestibular stimulation
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
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

No publications provided

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 August 20, 2014