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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01399671
• Other study ID #: SA10I220044
• Status: Completed
• Phase: N/A
• First received: July 12, 2011
• Last updated: March 2, 2012
• Start date: March 2011
• Est. completion date: January 2012

Study information

• Verified date: March 2011
• Source: Fuerza Aérea de Chile
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Comisión Nacional de Investigación Científica y Tecnológica
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• major depression patients,

• actual Hamilton score > 14

Exclusion Criteria:

• pregnant,

• neurological disorders,

• epilepsy,

• bipolar disorder,

• schizophrenia,

• anorexia,

• bulimia.

Study Design

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression
• Vestibular Diseases
• Vestibular Disorders

Intervention

Other:
• vestibular stimulation
vestibular stimulation

Locations

Country	Name	City	State
Chile	Centro de Medicina Aeroespacial	Santiago	Región Metropolitana

Sponsors (2)

Lead Sponsor	Collaborator
Fuerza Aérea de Chile	Pontificia Universidad Catolica de Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton depression rating score		1 month after the treatment start	Yes