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

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

Inclusion Criteria7

  • males
  • females
  • 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 Criteria4

  • 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)

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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