NCT02778256

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 19, 2016

Completed
13 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2024

Completed
Last Updated

May 7, 2024

Status Verified

May 1, 2024

Enrollment Period

5.9 years

First QC Date

May 17, 2016

Last Update Submit

May 6, 2024

Conditions

Bipolar DisorderDepression, Bipolar

Keywords

depression, bipolar disorder

Outcome Measures

Primary Outcomes (1)

  • Remission rates of depression.

    90 days

Secondary Outcomes (2)

  • Percentage of vestibular change.

    90 days

  • Response rates of depression

    90 days

Study Arms (2)

Vestibular stimulation

EXPERIMENTAL

Patients of this group will receive a specific vestibular stimulation technique.

Device: Vestibular stimulation

Sham vestibular stimulation

SHAM COMPARATOR

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

Interventions

Vestibular stimulationDEVICE

A specific vestibular stimulation technique is applied to the experimental group

Vestibular stimulation
Sham vestibular stimulationDEVICE

Sham vestibular stimulation using lower than threshold stimuli. The absence of vestibular nystagmus confirms that it is sham.

Sham vestibular stimulation

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • males
  • females
  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vest Brain, Centro de Estudios Neurovestibulares

Santiago, 7640617, Chile

RECRUITING

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Study Officials

  • Ana M Soza, M.D.

    Vest Brain,Centro de Estudios Neurovestibulares

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana M Soza, M.D.

CONTACT

+56992896736amsozaried@vestbrain.cl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2016

First Posted

May 19, 2016

Study Start

June 1, 2016

Primary Completion

May 1, 2022

Study Completion

October 30, 2024

Last Updated

May 7, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will share

IPD will be shared with other researchers by asking for the information to Dr. Ana María Soza's email: amsozaried@vestbrain.cl

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
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
Access Criteria
The criteria to access is asking for the information to Dr. Ana María Soza´s email amsozaried@vestbrain.cl
More information

Locations

CL(1)