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

May 16, 2022 updated by: Vest Brain,Centro de Estudios Neurovestibulares

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Chile
      • Santiago, Chile, 7640617
        • Recruiting
        • Vest Brain, Centro de Estudios Neurovestibulares
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Remission rates of depression.
Time Frame: 90 days
90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of vestibular change.
Time Frame: 90 days
90 days
Response rates of depression
Time Frame: 90 days
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vest Brain,Centro de Estudios Neurovestibulares

Investigators

  • Principal Investigator: Ana M Soza, M.D., Vest Brain,Centro de Estudios Neurovestibulares

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Actual)

May 1, 2022

Study Completion (Anticipated)

November 1, 2022

Study Registration Dates

First Submitted

May 17, 2016

First Submitted That Met QC Criteria

May 18, 2016

First Posted (Estimate)

May 19, 2016

Study Record Updates

Last Update Posted (Actual)

May 23, 2022

Last Update Submitted That Met QC Criteria

May 16, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VESTBRAIN001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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 Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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