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

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02778256
• Other study ID #: VESTBRAIN001
• Status: Recruiting
• Phase: N/A
• Start date: June 2016
• Est. completion date: October 30, 2024

Study information

• Verified date: May 2024
• Source: Vest Brain,Centro de Estudios Neurovestibulares
• Contact: Ana M Soza, M.D.
• Phone: +56992896736
• Email: amsozaried[@]vestbrain.cl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: October 30, 2024
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Depression, Bipolar

Intervention

Device:
• Vestibular stimulation
A specific vestibular stimulation technique is applied to the experimental group
• Sham vestibular stimulation
Sham vestibular stimulation using lower than threshold stimuli. The absence of vestibular nystagmus confirms that it is sham.

Locations

Country	Name	City	State
Chile	Vest Brain, Centro de Estudios Neurovestibulares	Santiago

Sponsors (1)

Lead Sponsor	Collaborator
Vest Brain,Centro de Estudios Neurovestibulares

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remission rates of depression.		90 days
Secondary	Percentage of vestibular change.		90 days
Secondary	Response rates of depression		90 days