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

Not Applicable

Recruiting

• Conditions: Bipolar Disorder; Depression, Bipolar
• Interventions: Device: Vestibular stimulation; Device: Sham vestibular stimulation

• Registration Number: NCT02778256
• Lead Sponsor: Vest Brain,Centro de Estudios Neurovestibulares

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 available

Study Timeline

• Study First Submitted: 2016-05-17
• Study First Submitted QC: 2016-05-18
• Study First Posted: 2016-05-19
• Study Start: 2016-06
• Primary Completion: 2022-05
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-07
• Study Completion: 2024-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vestibular stimulation	Vestibular stimulation	Patients of this group will receive a specific vestibular stimulation technique.
Sham vestibular stimulation	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.

Primary Outcome Measures

Name	Time	Method
Remission rates of depression.	90 days

Secondary Outcome Measures

Name	Time	Method
Percentage of vestibular change.	90 days
Response rates of depression	90 days

Trial Locations

Locations (1)

Vest Brain, Centro de Estudios Neurovestibulares; 🇨🇱 Santiago, Chile