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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02778256

Enrollment

120

Registered

2016-05-19

Start date

2016-06-30

Completion date

2024-10-30

Last updated

2024-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder, Depression, Bipolar

Keywords

depression, bipolar disorder

Brief 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.

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
Remission rates of depression.	90 days

Secondary

Measure	Time frame
Percentage of vestibular change.	90 days
Response rates of depression	90 days

Countries

Chile

Contacts

Primary ContactAna M Soza, M.D.

amsozaried@vestbrain.cl+56992896736

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026