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

Tracking Information

First Received Date ^ICMJE

July 12, 2011

Last Updated Date

March 2, 2012

Start Date ^ICMJE

March 2011

Primary Completion Date

January 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01399671 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Depression
Major Depression
Vestibular Disorders

Intervention ^ICMJE

Other: vestibular stimulation

vestibular stimulation

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2012

Primary Completion Date

January 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

major depression patients,
actual Hamilton score > 14

Exclusion Criteria:

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

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Chile

Administrative Information

NCT Number ^ICMJE

NCT01399671

Other Study ID Numbers ^ICMJE

SA10I220044

Has Data Monitoring Committee

Yes

Responsible Party

Ana Maria Soza Ried, Fuerza Aérea de Chile

Study Sponsor ^ICMJE

Fuerza Aérea de Chile

Collaborators ^ICMJE

Pontificia Universidad Catolica de Chile

Investigators ^ICMJE

Principal Investigator:

Ana M Soza, MD

Fuerza Aerea de Chile

Information Provided By

Fuerza Aérea de Chile

Verification Date

March 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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