Bipolar DisorderNCT02778256
Study of the Effectiveness of Vestibular Stimulation Treatment in the Depressive Phase of Bipolar Disorder
A study testing Vestibular stimulation in people with Bipolar Disorder and Depression, Bipolar, run by Vest Brain,Centro de Estudios Neurovestibulares at 1 site in Chile.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bipolar Disorder, Depression, Bipolar
- What is being tested?
- Vestibular stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChile
- Study dates
- Jun 2016to 30 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
Vest Brain, Centro de Estudios Neurovestibulares
Santiago, 7640617
Ana M Soza, M.D., +56992896736, amsozaried@vestbrain.cl
About this study
Official title: Study of the Effectiveness of Vestibular Stimulation as a Coadjuvant Treatment in the Depressive Phase of Bipolar Disorder
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.
- Conditions
- Bipolar Disorder, Depression, Bipolar
- Being tested
- Vestibular stimulation, Sham vestibular stimulation
- Keywords
- depression, bipolar disorder
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular stimulationDevice
A specific vestibular stimulation technique is applied to the experimental group
Sham vestibular stimulationDevice
Sham vestibular stimulation using lower than threshold stimuli. The absence of vestibular nystagmus confirms that it is sham.
| Study group | Role | What they receive |
|---|---|---|
| Vestibular stimulation | Experimental | Patients of this group will receive a specific vestibular stimulation technique. Receives: 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. Receives: Device: Sham vestibular stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission rates of depression.
Measured: 90 days
Secondary outcomes (2)
Percentage of vestibular change.
Measured: 90 days
Response rates of depression
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2016 (estimated)
- Study startJun 2016
- Primary completionMay 2022
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vest Brain,Centro de Estudios Neurovestibulares
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ana M Soza, M.D., Principal investigator, Vest Brain,Centro de Estudios Neurovestibulares
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02778256
- Sponsor's protocol ID
- VESTBRAIN001
- Status last verified
- May 2024
- First submitted
- 17 May 2016
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: IPD will be shared with other researchers by asking for the information to Dr. Ana María Soza's email: amsozaried@vestbrain.cl
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effectiveness of Vestibular Stimulation as a Coadjuvant Treatment in the Depressive Phase of Bipolar Disorder
- ClinicalTrials.gov ID
- NCT02778256
- Acronym / sponsor ID
- VESTBRAIN001
- Conditions
- Bipolar Disorder, Depression, Bipolar
- Keywords
- depression, bipolar disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Vest Brain,Centro de Estudios NeurovestibularesUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- May 2022 (actual)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 19 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vestibular stimulation | Experimental | Device: Vestibular stimulationPatients of this group will receive a specific vestibular stimulation technique. |
| Sham vestibular stimulation | Sham comparator | Device: Sham vestibular stimulationThis 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- males
- females
- 3 previous weeks with depression symptoms.
- bipolar disorder type I actual depressive phase
- bipolar disorder type II actual depressive phase
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vestibular stimulationA specific vestibular stimulation technique is applied to the experimental group | Device | Vestibular stimulation |
| Sham vestibular stimulationSham vestibular stimulation using lower than threshold stimuli. The absence of vestibular nystagmus confirms that it is sham. | Device | Sham vestibular stimulation |
Primary outcome
Remission rates of depression.
Time frame: 90 days
2 secondary outcomes
Percentage of vestibular change.
Time frame: 90 days
Response rates of depression
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Individual participant dataSharing planned: Yes. IPD will be shared with other researchers by asking for the information to Dr. Ana María Soza's email: amsozaried@vestbrain.cl
Related trials for Bipolar Disorder
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Recruiting
Safety and Feasibility of DBS for Bipolar Depression
Bipolar I Disorder, Bipolar Depression
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana M Soza, M.D. principal investigator
Vest Brain,Centro de Estudios Neurovestibulares
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vestibular stimulation in people with Bipolar Disorder and Depression, Bipolar, run by Vest Brain,Centro de Estudios Neurovestibulares at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ana M Soza, M.D. (+56992896736, amsozaried@vestbrain.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remission rates of depression. (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2024.