UnknownNot Applicable

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

Chile120 participantsStarted 2016-06

Plain-language 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.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Remission rates of depression.

Timeframe: 90 days

Trial details

NCT IDNCT02778256

SponsorVest Brain,Centro de Estudios Neurovestibulares

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-05

Contact for this trial

Ana M Soza, M.D.

+56992896736 amsozaried@vestbrain.cl

View on ClinicalTrials.gov More Bipolar Disorder trials