Bipolar DisorderBDmarkerNCT02827045
Study of a Vestibular Biomarker of Phase in Bipolar Disorder
An observational study of Bipolar Disorder and Depression, Bipolar, run by Vest Brain,Centro de Estudios Neurovestibulares.
Trial summary
Bipolar Disorder show cyclic changes of mood between depression (depressive phase) and mania (maniac phase). Vestibular tests have been shown high sensibility and specificity as a biological marker for major depression. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder, Depression, Bipolar
- What is being tested?
- Vestibular test
- Type of treatment
- Medical device
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Oct 2024
- Phase
- Observational
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: study population come from psychiatric care consults
Who may be able to join
- Bipolar disorder I or II
- depressive phase of bipolar disorder
- maniac phase of bipolar disorder
- euthimic phase of bipolar disorder
Who cannot join
- drugs addiction
- alcohol addiction
- neurologic condition, disorder
About this study
Official title: Exploratory Study of a Vestibular Biomarker of Phase in Bipolar Disorder
Bipolar Disorder show cyclic changes of mood between depression (depressive phase) and mania (maniac phase). Vestibular tests have been shown high sensibility and specificity as a biological marker for major depression. This exploratory investigation will measure and compare the vestibular activity of bipolar disorder patients during different phases ( 6 depressed phase, 6 maniac phase, 6 euthimic and 6 control healthy subjects).
- Conditions
- Bipolar Disorder, Depression, Bipolar
- Being tested
- Vestibular test
- 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 testDevice
| Study group | Role | What they receive |
|---|---|---|
| Depressive phase | Vestibular test Receives: Device: Vestibular test | |
| Maniac phase | Vestibular test Receives: Device: Vestibular test | |
| Euthimic phase | Vestibular test Receives: Device: Vestibular test | |
| Healthy subject | Vestibular test Receives: Device: Vestibular test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vestibular test
Measured: December 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2024 (estimated)
- Study completionOct 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vest Brain,Centro de Estudios Neurovestibulares
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Maria Soza Ried, Vest Brain,Centro de Estudios Neurovestibulares
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02827045
- Sponsor's protocol ID
- VESTBRAIN002
- Acronym
- BDmarker
- Status last verified
- May 2024
- First submitted
- 6 Jul 2016
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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
- Exploratory Study of a Vestibular Biomarker of Phase in Bipolar Disorder
- ClinicalTrials.gov ID
- NCT02827045
- Acronym / sponsor ID
- BDmarker / VESTBRAIN002
- Conditions
- Bipolar Disorder, Depression, Bipolar
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Vest Brain,Centro de Estudios NeurovestibularesUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 11 Jul 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.
Bipolar Disorder show cyclic changes of mood between depression (depressive phase) and mania (maniac phase). Vestibular tests have been shown high sensibility and specificity as a biological marker for major depression. This exploratory investigation will measure and compare the vestibular activity of bipolar disorder patients during different phases ( 6 depressed phase, 6 maniac phase, 6 euthimic and 6 control healthy subjects).
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Depressive phase | – | Device: Vestibular testVestibular test |
| Maniac phase | – | Device: Vestibular testVestibular test |
| Euthimic phase | – | Device: Vestibular testVestibular test |
| Healthy subject | – | Device: Vestibular testVestibular test |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- study population come from psychiatric care consults
Key inclusion criteria (4 listed)
- Bipolar disorder I or II
- depressive phase of bipolar disorder
- maniac phase of bipolar disorder
- euthimic phase of bipolar disorder
Key exclusion criteria (3 listed)
- drugs addiction
- alcohol addiction
- neurologic condition, disorder
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 test | Device | Depressive phase, Euthimic phase, Healthy subject, Maniac phase |
Primary outcome
Vestibular test
Time frame: December 2017
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: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder and Depression, Bipolar, run by Vest Brain,Centro de Estudios Neurovestibulares.
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 4 inclusion and 3 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.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vestibular test (time frame: December 2017). 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.