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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
Sponsor:
Information provided by (Responsible Party):
Vest Brain,Centro de Estudios Neurovestibulares

Study Description
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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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Depression, Bipolar Device: Vestibular stimulation Device: Sham vestibular stimulation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Remission rates of depression. [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. Percentage of vestibular change. [ Time Frame: 90 days ]
  2. Response rates of depression [ Time Frame: 90 days ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Ana M Soza, M.D. +56992896736 amsozaried@vestbrain.cl

Locations
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Chile
Vest Brain, Centro de Estudios Neurovestibulares Recruiting
Santiago, Chile, 7640617
Contact: Ana M Soza, M.D.    +56992896736    amsozaried@vestbrain.cl   
Sponsors and Collaborators
Vest Brain,Centro de Estudios Neurovestibulares
Investigators
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Principal Investigator: Ana M Soza, M.D. Vest Brain,Centro de Estudios Neurovestibulares
More Information
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Responsible Party: Vest Brain,Centro de Estudios Neurovestibulares
ClinicalTrials.gov Identifier: NCT02778256    
Other Study ID Numbers: VESTBRAIN001
First Posted: May 19, 2016    Key Record Dates
Last Update Posted: July 11, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Vest Brain,Centro de Estudios Neurovestibulares:
depression, bipolar disorder
Additional relevant MeSH terms:
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Disease
Depression
Bipolar Disorder
Pathologic Processes
 Behavioral Symptoms
Mental Disorders
Bipolar and Related Disorders