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RecruitingNot ApplicableNCT02778256

Study of the Effectiveness of Vestibular Stimulation Treatment in the Depressive Phase of Bipolar Disorder

Study of the Effectiveness of Vestibular Stimulation as a Coadjuvant Treatment in the Depressive Phase of Bipolar Disorder

Sponsor

Vest Brain,Centro de Estudios Neurovestibulares

Enrollment

120 participants

Start Date

Jun 1, 2016

Study Type

INTERVENTIONAL

Conditions

Bipolar DisorderDepression Bipolar

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.

Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether vestibular stimulation — a gentle stimulation of the inner ear's balance system — can help relieve depression in people with bipolar disorder who are currently in a depressive episode. **You may be eligible if...** - You have been diagnosed with bipolar disorder type I or type II and are currently in a depressive episode - You have had depressive symptoms for at least 3 weeks - Your depression score on a standard rating scale (MADRS) is 20 or higher, indicating at least moderate depression - Your psychiatric medications have been stable for at least 2 weeks before joining the study **You may NOT be eligible if...** - You are pregnant - You have a neurological disorder - You have been using drugs or alcohol in the 2 weeks before the study - You are currently in a manic or hypomanic episode (elevated or irritable mood) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEVestibular stimulation

A specific vestibular stimulation technique is applied to the experimental group

DEVICESham vestibular stimulation

Sham vestibular stimulation using lower than threshold stimuli. The absence of vestibular nystagmus confirms that it is sham.

Locations(1)

Vest Brain, Centro de Estudios Neurovestibulares

Santiago, Chile

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NCT02778256

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