Study of the Effectiveness of Vestibular Stimulation as a Coadjuvant Treatment in the Depressive Phase of Bipolar Disorder
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bipolar Disorder
- Sponsor
- Vest Brain,Centro de Estudios Neurovestibulares
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Remission rates of depression.
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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)
Outcomes
Primary Outcomes
Remission rates of depression.
Time Frame: 90 days
Secondary Outcomes
- Percentage of vestibular change.(90 days)
- Response rates of depression(90 days)