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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Chile
Vest Brain, Centro de Estudios Neurovestibulares
RECRUITING
Santiago
Contact Information
Primary
Ana M Soza, M.D.
amsozaried@vestbrain.cl
+56992896736
Time Frame
Start Date: 2016-06
Estimated Completion Date: 2024-10-30
Participants
Target number of participants: 120
Treatments
Experimental: Vestibular stimulation
Patients of this group will receive a specific vestibular stimulation technique.
Sham_comparator: Sham vestibular stimulation
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.
Related Therapeutic Areas
Sponsors
Leads: Vest Brain,Centro de Estudios Neurovestibulares

This content was sourced from clinicaltrials.gov

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