Study of the Effectiveness of Vestibular Stimulation Treatment in the Depressive Phase of Bipolar Disorder
Primary Purpose
Bipolar Disorder, Depression, Bipolar
Status
Recruiting
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Vestibular stimulation
Sham vestibular stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Disorder focused on measuring depression, bipolar disorder
Eligibility 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)
Sites / Locations
- Vest Brain, Centro de Estudios NeurovestibularesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Vestibular stimulation
Sham vestibular stimulation
Arm Description
Patients of this group will receive a specific vestibular stimulation technique.
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.
Outcomes
Primary Outcome Measures
Remission rates of depression.
Secondary Outcome Measures
Percentage of vestibular change.
Response rates of depression
Full Information
NCT ID
NCT02778256
First Posted
May 17, 2016
Last Updated
May 16, 2022
Sponsor
Vest Brain,Centro de Estudios Neurovestibulares
1. Study Identification
Unique Protocol Identification Number
NCT02778256
Brief Title
Study of the Effectiveness of Vestibular Stimulation Treatment in the Depressive Phase of Bipolar Disorder
Official Title
Study of the Effectiveness of Vestibular Stimulation as a Coadjuvant Treatment in the Depressive Phase of Bipolar Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 2016 (undefined)
Primary Completion Date
May 2022 (Actual)
Study Completion Date
November 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vest Brain,Centro de Estudios Neurovestibulares
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder, Depression, Bipolar
Keywords
depression, bipolar disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vestibular stimulation
Arm Type
Experimental
Arm Description
Patients of this group will receive a specific vestibular stimulation technique.
Arm Title
Sham vestibular stimulation
Arm Type
Sham Comparator
Arm Description
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 Type
Device
Intervention Name(s)
Vestibular stimulation
Intervention Description
A specific vestibular stimulation technique is applied to the experimental group
Intervention Type
Device
Intervention Name(s)
Sham vestibular stimulation
Intervention Description
Sham vestibular stimulation using lower than threshold stimuli. The absence of vestibular nystagmus confirms that it is sham.
Primary Outcome Measure Information:
Title
Remission rates of depression.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Percentage of vestibular change.
Time Frame
90 days
Title
Response rates of depression
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ana M Soza, M.D.
Phone
+56992896736
Email
amsozaried@vestbrain.cl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana M Soza, M.D.
Organizational Affiliation
Vest Brain,Centro de Estudios Neurovestibulares
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vest Brain, Centro de Estudios Neurovestibulares
City
Santiago
ZIP/Postal Code
7640617
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana M Soza, M.D.
Phone
+56992896736
Email
amsozaried@vestbrain.cl
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD will be shared with other researchers by asking for the information to Dr. Ana María Soza's email: amsozaried@vestbrain.cl
IPD Sharing Time Frame
The data will be available in December 2019-March 2020 and can be asked to Dr. Ana María Soza´s email amsozaried@vestbrain.cl
IPD Sharing Access Criteria
The criteria to access is asking for the information to Dr. Ana María Soza´s email amsozaried@vestbrain.cl
IPD Sharing URL
https://www.vestbrain.cl
Learn more about this trial
Study of the Effectiveness of Vestibular Stimulation Treatment in the Depressive Phase of Bipolar Disorder
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