Study of the Effectiveness of Vestibular Stimulation Treatment in the Depressive Phase of Bipolar Disorder
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|ClinicalTrials.gov Identifier: NCT02778256|
Recruitment Status : Unknown
Verified July 2016 by Vest Brain,Centro de Estudios Neurovestibulares.
Recruitment status was: Recruiting
First Posted : May 19, 2016
Last Update Posted : July 11, 2016
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder Depression, Bipolar||Device: Vestibular stimulation Device: Sham vestibular stimulation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Study of the Effectiveness of Vestibular Stimulation as a Coadjuvant Treatment in the Depressive Phase of Bipolar Disorder|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: Vestibular stimulation
Patients of this group will receive a specific vestibular stimulation technique.
Device: Vestibular stimulation
A specific vestibular stimulation technique is applied to the experimental group
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.
Device: Sham vestibular stimulation
Sham vestibular stimulation using lower than threshold stimuli. The absence of vestibular nystagmus confirms that it is sham.
- Remission rates of depression. [ Time Frame: 90 days ]
- Percentage of vestibular change. [ Time Frame: 90 days ]
- Response rates of depression [ Time Frame: 90 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02778256
|Contact: Ana M Soza, M.D.||+firstname.lastname@example.org|
|Vest Brain, Centro de Estudios Neurovestibulares||Recruiting|
|Santiago, Chile, 7640617|
|Contact: Ana M Soza, M.D. +56992896736 email@example.com|
|Principal Investigator:||Ana M Soza, M.D.||Vest Brain,Centro de Estudios Neurovestibulares|