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

Vest Brain,Centro de Estudios Neurovestibulares

Status: Enrolling

Conditions: Depression, Bipolar; Bipolar Disorder

Treatments: Device: Sham vestibular stimulation; Device: Vestibular stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02778256

VESTBRAIN001

Details and patient eligibility

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

Vestibular stimulation

Experimental group

Description:

Patients of this group will receive a specific vestibular stimulation technique.

Treatment:

Device: Vestibular stimulation

Sham vestibular stimulation

Sham Comparator group

Description:

This group of patients will receive sham vestibular stimulation, similar to experimental group vestibular stimulation in the range of under threshold frequencies undistinguished from real vestibular stimulation. The absence of vestibular nystagmic response confirms that the stimulus is sham.

Treatment:

Device: Sham vestibular stimulation