Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
NCT02778256

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

Led by Vest Brain,Centro de Estudios Neurovestibulares · Updated on 2024-05-07

120

Participants Needed

1

Research Sites

439 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female participants
  • Experiencing depressive symptoms for at least 3 weeks
  • Diagnosed with bipolar disorder type I or II currently in a depressive phase
  • Montgomery Asberg Depression Scale (MADRS) score of 20 or higher
  • Stable psychiatric medication for at least 2 weeks before joining the study
Not Eligible

You will not qualify if you...

  • Pregnant individuals
  • People with neurological disorders
  • Abuse of drugs or alcohol in the 2 weeks prior to joining the study
  • Those currently experiencing a manic state (Young Mania Scale score above 7)

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Vest Brain, Centro de Estudios Neurovestibulares

Santiago, Chile, 7640617

Actively Recruiting

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Research Team

A

Ana M Soza, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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