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

Primary Purpose

Depression, Major Depression, Vestibular Disorders

Status

Completed

Phase

Not Applicable

Locations

Chile

Study Type

Interventional

Intervention

vestibular stimulation

About this trial

This is an interventional treatment trial for Depression focused on measuring depression, vestibular

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

major depression patients,
actual Hamilton score > 14

Exclusion Criteria:

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

Sites / Locations

Centro de Medicina Aeroespacial

Outcomes

Primary Outcome Measures

Hamilton depression rating score

Secondary Outcome Measures

Full Information

NCT ID

NCT01399671

First Posted

July 12, 2011

Last Updated

March 2, 2012

Sponsor

Fuerza Aérea de Chile

Collaborators

Pontificia Universidad Catolica de Chile

1. Study Identification

Unique Protocol Identification Number

NCT01399671

Brief Title

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

Official Title

Clinical Randomized Trial to Evaluate the Efficacy of Vestibular Stimulation as Coadjuvant Therapy in Major Depression

Study Type

Interventional

2. Study Status

Record Verification Date

March 2011

Overall Recruitment Status

Completed

Study Start Date

March 2011 (undefined)

Primary Completion Date

January 2012 (Actual)

Study Completion Date

January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fuerza Aérea de Chile

Collaborators

Pontificia Universidad Catolica de Chile

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression, Major Depression, Vestibular Disorders

Keywords

depression, vestibular

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Other

Intervention Name(s)

vestibular stimulation

Intervention Description

vestibular stimulation

Primary Outcome Measure Information:

Title

Hamilton depression rating score

Time Frame

1 month after the treatment start

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: major depression patients, actual Hamilton score > 14 Exclusion Criteria: pregnant, neurological disorders, epilepsy, bipolar disorder, schizophrenia, anorexia, bulimia.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ana M Soza, MD

Organizational Affiliation

Fuerza Aerea de Chile

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centro de Medicina Aeroespacial

City

Santiago

State/Province

Región Metropolitana

Country

Chile

12. IPD Sharing Statement

Learn more about this trial

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

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