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

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ClinicalTrials.gov Identifier: NCT01399671
Recruitment Status : Completed
First Posted : July 22, 2011
Last Update Posted : March 5, 2012
Sponsor:
Collaborator:
Pontificia Universidad Catolica de Chile
Information provided by (Responsible Party):
Ana Maria Soza Ried, Fuerza Aérea de Chile

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Phase
Depression Major Depression Vestibular Disorders Other: vestibular stimulation Not Applicable

Study Design
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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
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

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Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
    Other: vestibular stimulation
    vestibular stimulation

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
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:
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