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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02778256
Other study ID # VESTBRAIN001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 2016
Est. completion date October 30, 2024

Study information

Verified date May 2024
Source Vest Brain,Centro de Estudios Neurovestibulares
Contact Ana M Soza, M.D.
Phone +56992896736
Email amsozaried@vestbrain.cl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Vestibular stimulation has been shown to be a very effective noninvasive treatment for major depression. Bipolar disorder is a mental illness that presents cyclic sequences of depressive and euphoric states. Depressive phases of bipolar disorder are difficult to treat and usually are resistant to actual available treatments. This study investigates the effectiveness of a particular technique of vestibular stimulation in a group of 120 bipolar type I and II patients. After randomization 60 of them will receive specific vestibular stimulation (experimental group) and 60 will receive a sham vestibular stimulation.The study will conducted in Vest Brain, Centro de Estudios Neurovestibulares, in Chile.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date October 30, 2024
Est. primary completion date May 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - males - females - 3 previous weeks with depression symptoms. - bipolar disorder type I actual depressive phase - bipolar disorder type II actual depressive phase - Montgomery Asberg depression scale(MADRS) score equal or more than 20 - stable psychiatric medication during 2 weeks previous the recruitment Exclusion Criteria: - pregnancy - neurologic disorder - drugs or alcohol abuse during the 2 weeks previous the recruitment - presence of maniac state(Young mania scale score more than 7)

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Vestibular stimulation
A specific vestibular stimulation technique is applied to the experimental group
Sham vestibular stimulation
Sham vestibular stimulation using lower than threshold stimuli. The absence of vestibular nystagmus confirms that it is sham.

Locations

Country Name City State
Chile Vest Brain, Centro de Estudios Neurovestibulares Santiago

Sponsors (1)

Lead Sponsor Collaborator
Vest Brain,Centro de Estudios Neurovestibulares

Country where clinical trial is conducted

Chile, 

Outcome

Type Measure Description Time frame Safety issue
Primary Remission rates of depression. 90 days
Secondary Percentage of vestibular change. 90 days
Secondary Response rates of depression 90 days
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