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

Study Overview
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Brief Summary
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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.

Official Title
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Study of the Effectiveness of Vestibular Stimulation as a Coadjuvant Treatment in the Depressive Phase of Bipolar Disorder

Conditions
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Bipolar Disorder, Depression, Bipolar

Intervention / Treatment
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* Device: Vestibular stimulation
* Device: Sham vestibular stimulation


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vestibular stimulation<br>Patients of this group will receive a specific vestibular stimulation technique. | Device: Vestibular stimulation<br>* A specific vestibular stimulation technique is applied to the experimental group<br>|
| Sham Comparator: Sham vestibular stimulation<br>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. | Device: Sham vestibular stimulation<br>* Sham vestibular stimulation using lower than threshold stimuli. The absence of vestibular nystagmus confirms that it is sham.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remission rates of depression. |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of vestibular change. |  | 90 days | 
| Response rates of depression |  | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depression, bipolar disorder