DepressionNCT03421847
Study of Rotatory Vestibular Tests in Major Depression Patients and Healthy Control Subjects.
An observational study of Depression and Vestibular Disorder, run by Vest Brain,Centro de Estudios Neurovestibulares.
Trial summary
This study evaluates the vestibular activity in major depression patients and healthy controls using the rotatory test and electronystagmography. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Vestibular Disorder
- What is being tested?
- Rotatory vestibular test
- How many people
- 41 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2005to 15 Dec 2006
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Depression Group patients were selected by psychiatrists from the ambulatory Mental Health consult of the Hospital; the Control Group included 20 healthy volunteers, composed by desk workers from the center.
Who may be able to join
- male and females adults (18 years or older)
- met the Diagnosing and Statistical Manual of Mental Disorders (DSM-IV-R, American Psychiatric Association, 2000) criterion.
- had a score of 12 or more in the Hamilton Rating Scale, 21 items for Depression.
- with or without actual pharmacological treatment, except benzodiazepines that were suspended 24 hours before the rotary test when corresponding.
Who cannot join
- pregnant women
- neurologic disorders.
About this study
This study evaluates the vestibular activity in major depression patients and healthy controls using the rotatory test and electronystagmography.
Read the detailed description
Previous studies showed abnormal vestibular activity in major depression patients using caloric vestibular tests. The present study investigates the vestibular response to vestibular rotatory tests in major depression subjects and healthy controls.
- Conditions
- Depression, Vestibular Disorder
- Being tested
- Rotatory vestibular test
- Keywords
- depression, vestibular disorder, rotatory test, electronystagmography
- Medical subject headings
- Depression, Vestibular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotatory vestibular testDiagnostic test
We will measure Depression and Healthy subjects vestibular activity by Rotatory Vestibular tests
| Study group | Role | What they receive |
|---|---|---|
| Major Depression Group | We will measure the vestibular activity of Major depression patients with Rotatory Test and electronystagmography Receives: Diagnostic Test: Rotatory vestibular test | |
| Healthy Control Group | We will measure the vestibular activity of Healthy subjects with Rotatory Test and electronystagmography. Receives: Diagnostic Test: Rotatory vestibular test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vestibular Activity
The primary outcome corresponds to the vestibular activity. The vestibular stimulation provided by the rotatory chair is sensed by the inner ear´s vestibular receptors and generates reflex ocular movements(Vestibulo Ocular Reflex) registrated by electronystagmography. The main outcome corresponds to the asymmetry of the vestibular activity between both ears.
Measured: Vestibular rotatory test for each participant is about 50- 60 minutes. One rotatory test per participant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start1 Jul 2005
- Primary completion15 Dec 2006
- Study completion15 Dec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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-control
- Time perspective
- Other
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vest Brain,Centro de Estudios Neurovestibulares
- Sponsor type
- University, hospital or other
- Collaborators
- Centro de Medicina Aeroespacial.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03421847
- Sponsor's protocol ID
- ROTDEPR01
- Status last verified
- Feb 2018
- First submitted
- 29 Jan 2018
- Last updated
- 6 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share all collected vestibular data of IPD after 6 months of publication.
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Rotatory Vestibular Tests in Major Depression Patients and Healthy Control Subjects.
- ClinicalTrials.gov ID
- NCT03421847
- Acronym / sponsor ID
- ROTDEPR01
- Conditions
- Depression, Vestibular Disorder
- Keywords
- depression, vestibular disorder, rotatory test, electronystagmography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Vest Brain,Centro de Estudios NeurovestibularesUniversity, hospital or other
- Collaborators
- Centro de Medicina Aeroespacial.
- Study start
- 1 Jul 2005 (actual)
- Primary completion
- 15 Dec 2006 (actual)
- Study completion
- 15 Dec 2006 (actual)
- First posted
- 5 Feb 2018 (actual)
- 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.
This study evaluates the vestibular activity in major depression patients and healthy controls using the rotatory test and electronystagmography.
Detailed description
Previous studies showed abnormal vestibular activity in major depression patients using caloric vestibular tests. The present study investigates the vestibular response to vestibular rotatory tests in major depression subjects and healthy controls.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Major Depression Group | – | Diagnostic Test: Rotatory vestibular testWe will measure the vestibular activity of Major depression patients with Rotatory Test and electronystagmography |
| Healthy Control Group | – | Diagnostic Test: Rotatory vestibular testWe will measure the vestibular activity of Healthy subjects with Rotatory Test and electronystagmography. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Depression Group patients were selected by psychiatrists from the ambulatory Mental Health consult of the Hospital; the Control Group included 20 healthy volunteers, composed by desk workers from the center.
Key inclusion criteria (4 listed)
- male and females adults (18 years or older)
- met the Diagnosing and Statistical Manual of Mental Disorders (DSM-IV-R, American Psychiatric Association, 2000) criterion.
- had a score of 12 or more in the Hamilton Rating Scale, 21 items for Depression.
- with or without actual pharmacological treatment, except benzodiazepines that were suspended 24 hours before the rotary test when corresponding.
Key exclusion criteria (2 listed)
- pregnant women
- neurologic disorders.
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 |
|---|---|---|
| Rotatory vestibular testWe will measure Depression and Healthy subjects vestibular activity by Rotatory Vestibular tests | Diagnostic test | Healthy Control Group, Major Depression Group |
Primary outcome
Vestibular Activity
Time frame: Vestibular rotatory test for each participant is about 50- 60 minutes. One rotatory test per participant.
The primary outcome corresponds to the vestibular activity. The vestibular stimulation provided by the rotatory chair is sensed by the inner ear´s vestibular receptors and generates reflex ocular movements(Vestibulo Ocular Reflex) registrated by electronystagmography. The main outcome corresponds to the asymmetry of the vestibular activity between both ears.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2018.
- Individual participant dataSharing planned: Yes. We plan to share all collected vestibular data of IPD after 6 months of publication.
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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 Depression and Vestibular Disorder, 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 2 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: finished, as of the sponsor's last update on 6 Feb 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Activity (time frame: Vestibular rotatory test for each participant is about 50- 60 minutes. One rotatory test per participant.). 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 6 Feb 2018.