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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

Tracking Information
First Submitted Date  ICMJE May 17, 2016
First Posted Date  ICMJE May 19, 2016
Last Update Posted Date July 11, 2016
Study Start Date  ICMJE June 2016
Estimated Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 18, 2016)
Remission rates of depression. [ Time Frame: 90 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 18, 2016)
  • Percentage of vestibular change. [ Time Frame: 90 days ]
  • Response rates of depression [ Time Frame: 90 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of the Effectiveness of Vestibular Stimulation Treatment in the Depressive Phase of Bipolar Disorder
Official Title  ICMJE Study of the Effectiveness of Vestibular Stimulation as a Coadjuvant Treatment in the Depressive Phase of Bipolar Disorder
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Bipolar Disorder
  • Depression, Bipolar
Intervention  ICMJE
  • Device: Vestibular stimulation
    A specific vestibular stimulation technique is applied to the experimental group
  • Device: Sham vestibular stimulation
    Sham vestibular stimulation using lower than threshold stimuli. The absence of vestibular nystagmus confirms that it is sham.
Study Arms  ICMJE
  • Experimental: Vestibular stimulation
    Patients of this group will receive a specific vestibular stimulation technique.
    Intervention: Device: Vestibular stimulation
  • 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.
    Intervention: Device: Sham vestibular stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 18, 2016)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Chile
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02778256
Other Study ID Numbers  ICMJE VESTBRAIN001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Vest Brain,Centro de Estudios Neurovestibulares
Study Sponsor  ICMJE Vest Brain,Centro de Estudios Neurovestibulares
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ana M Soza, M.D. Vest Brain,Centro de Estudios Neurovestibulares
PRS Account Vest Brain,Centro de Estudios Neurovestibulares
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP