DepressionNCT02523105
Evaluation of Use of Brain Activity Monitoring for Evaluation of Depression Treatment
A study testing EEG monitoring in people with Depression, run by Brainmarc Ltd. at 2 sites in Israel.
Trial summary
This study evaluates the use of brain activity monitoring for early identification of pharmaceutical treatment efficacy and development of depression deterioration events. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- EEG monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 2 sitesIsrael
- Study dates
- Sep 2015to 5 Jan 2017
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 -70 years (Adult, Senior)
- Able and willing to comply with all study requirements.
- Additional Inclusion Criteria for Arm I
- Diagnosed with depression
- Being within 2 days of receiving pharmaceutical treatment for depression for the first
Show all 10Show fewer
- time or changing dose or changing type of current pharmaceutical treatment or addition to
- drug of current pharmaceutical treatment.
- Additional Inclusion Criteria for Arm II
- Brief Symptom Inventory (BSI < 2.3).
Who cannot join
- The participant may not enter the study if ANY of the following apply:
- Diagnosed with Psychotic disorder.
- Diagnosed with Central Neurological disorder.
- A user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse
- or dependence.
- Hearing disorder and/or known ear drum impairment.
- High suicide risk as judged by the research team.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Evaluation of Use of Brain Activity Monitoring for Early Identification of Pharmaceutical Treatment Efficacy and Development of Depression Deterioration Events.
This study evaluates the use of brain activity monitoring for early identification of pharmaceutical treatment efficacy and development of depression deterioration events.
Read the detailed description
The study will be conducted in two arms:
In arm I, participants diagnosed with depression. In arm II, healthy participants.
Arm I - Participants that need to start or switch their pharmacological antidepressant therapy will be recruited. Their clinical status will be evaluated and their EEG characteristics will be collected.
Arm II - Clinical and EEG characteristics of Healthy volunteers will collected on a similar timetable.
- Conditions
- Depression
- Being tested
- EEG monitoring
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEG monitoringDevice
EEG evaluation will be done using two off the shelf EEG devices for research and consumer use. The first one is a device called MindWave by NeuroSky ltd (http://neurosky.com) the second called EPOC by Emotiv ltd (https://emotiv.com/epoc.php).
EEG evaluation will be conducted for a total duration of 20 minutes with and without auditory stimulation. The auditory stimulation will be performed using standard headphone or earphones to reduce external noises.
| Study group | Role | What they receive |
|---|---|---|
| Participants diagnosed with depression. | Other | EEG monitoring and evaluation Receives: Device: EEG monitoring |
| Healthy participants. | Other | EEG monitoring and evaluation Receives: Device: EEG monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tuning and evaluation of use of EEG analysis of brain prefrontal activity for mental status evaluation.
Outcome measures: optimal EEG device, sampling duration, frequency, and EEG measure dynamics correlation with depression clinical dynamics.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2015 (estimated)
- Study startSep 2015
- Primary completion9 Oct 2016
- Study completion5 Jan 2017
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brainmarc Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuval Bloch, MD, Principal investigator, Shalvata Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02523105
- Sponsor's protocol ID
- 0010-15
- Status last verified
- Jul 2016
- First submitted
- 10 Aug 2015
- Last updated
- 26 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Use of Brain Activity Monitoring for Early Identification of Pharmaceutical Treatment Efficacy and Development of Depression Deterioration Events.
- ClinicalTrials.gov ID
- NCT02523105
- Acronym / sponsor ID
- 0010-15
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Brainmarc Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2015 (actual)
- Primary completion
- 9 Oct 2016 (actual)
- Study completion
- 5 Jan 2017 (actual)
- First posted
- 14 Aug 2015 (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.
This study evaluates the use of brain activity monitoring for early identification of pharmaceutical treatment efficacy and development of depression deterioration events.
Detailed description
The study will be conducted in two arms:
In arm I, participants diagnosed with depression. In arm II, healthy participants.
Arm I - Participants that need to start or switch their pharmacological antidepressant therapy will be recruited. Their clinical status will be evaluated and their EEG characteristics will be collected.
Arm II - Clinical and EEG characteristics of Healthy volunteers will collected on a similar timetable.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants diagnosed with depression. | Other | Device: EEG monitoringEEG monitoring and evaluation |
| Healthy participants. | Other | Device: EEG monitoringEEG monitoring and evaluation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 -70 years (Adult, Senior)
- Able and willing to comply with all study requirements.
- Additional Inclusion Criteria for Arm I
- Diagnosed with depression
Key exclusion criteria (7 listed)
- Diagnosed with Psychotic disorder.
- Diagnosed with Central Neurological disorder.
- A user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse
- or dependence.
- Hearing disorder and/or known ear drum impairment.
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 |
|---|---|---|
| EEG monitoringEEG evaluation will be done using two off the shelf EEG devices for research and consumer use. The first one is a device called MindWave by NeuroSky ltd (http://neurosky.com) the second called EPOC by Emotiv ltd (https://emotiv.com/epoc.php). EEG evaluation will be conducted for a total duration of 20 minutes with and without auditory stimulation. The auditory stimulation will be performed using standard headphone or earphones to reduce external noises. | Device | Healthy participants., Participants diagnosed with depression. |
Primary outcome
Tuning and evaluation of use of EEG analysis of brain prefrontal activity for mental status evaluation.
Time frame: 12 months
Outcome measures: optimal EEG device, sampling duration, frequency, and EEG measure dynamics correlation with depression clinical dynamics.
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 26 Apr 2018.
- A Pilot Study of Possible Easy-to-Use Electrophysiological Index for Early Detection of Antidepressive Treatment Non-ResponseLink provided by the sponsor.
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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.
Yuval Bloch, MD principal investigator
Shalvata Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EEG monitoring in people with Depression, run by Brainmarc Ltd. at 2 sites in Israel.
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 10 inclusion and 7 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 26 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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. 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?
Tuning and evaluation of use of EEG analysis of brain prefrontal activity for mental status evaluation. (time frame: 12 months). 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 26 Apr 2018.