Effect of vestibular stimulation on depression in bipolar disorder
Study of the Effectiveness of Vestibular Stimulation as a Coadjuvant Treatment in the Depressive Phase of Bipolar Disorder
NA · Vest Brain,Centro de Estudios Neurovestibulares · NCT02778256
This study is testing if a new noninvasive treatment called vestibular stimulation can help people with bipolar disorder who are experiencing depression feel better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Vest Brain,Centro de Estudios Neurovestibulares (other) |
| Locations | 1 site (Santiago) |
| Trial ID | NCT02778256 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of vestibular stimulation as a noninvasive treatment for the depressive phase of bipolar disorder. It involves 120 patients with bipolar type I and II, who will be randomly assigned to receive either specific vestibular stimulation or a sham treatment. The primary focus is on patients experiencing depressive symptoms for at least three weeks, with a Montgomery Asberg depression scale score of 20 or higher. The study is conducted at Vest Brain, Centro de Estudios Neurovestibulares in Chile.
Who should consider this trial
Good fit: Ideal candidates are adults with bipolar disorder type I or II currently experiencing a depressive phase.
Not a fit: Patients with a manic state or those with neurological disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new, effective option for managing depressive episodes in bipolar disorder patients.
How similar studies have performed: Other studies have shown vestibular stimulation to be effective for major depression, suggesting potential for success in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Santiago
- Vest Brain, Centro de Estudios Neurovestibulares — Santiago, Chile (RECRUITING)
Study contacts
- Principal investigator: Ana M Soza, M.D. — Vest Brain,Centro de Estudios Neurovestibulares
- Study coordinator: Ana M Soza, M.D.
- Email: amsozaried@vestbrain.cl
- Phone: +56992896736
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Bipolar Disorder, Depression, Bipolar, depression, bipolar disorder