Major Depressive DisorderMOODNCT05815459
Mobile Observation Of Depression
An observational study of Major Depressive Disorder and Major Depressive Episode, run by Emteq Ltd at 1 site in United Kingdom.
Trial summary
The primary aim of this project is to test if OCOsense glasses can function as a digital phenotyping tool derived from behavioural and physiological signals related to facial expression and motion recorded using the glasses. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Major Depressive Disorder, Major Depressive Episode, Bipolar Disorder
- What is being tested?
- OCOsense
- Type of treatment
- Medical device
- How many people
- 84 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Jul 2022to 1 Feb 2023
- 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 40 years
- All sexes
- Adult
Study population: Convenience sampling of young adults.
Who may be able to join
- All participants:
- Ability to read \& understand English. This is because the majority of our questionnaires are validated in the English language only.
- Able to walk, sit, lay and stand unaided
- Clinical cases:
- ● ≥ 15 on the Patient health Questionnaire-9 (PhQ9) (moderate to severe depression)
Who cannot join
- Healthy control participants:
- Self-reported current or past history (suspected or diagnosed) of any psychiatric condition
- <5 on the Generalised Anxiety Disorder-7 questionnaire (GAD-7)
- <5 on the PhQ-9 (no depression)
- Receiving medication for any psychiatric disorder (excluding fibromyalgia)
- All participants:
Show all 10Show fewer
- < 18 years of age or >40 years of age
- Anatomical constraints that affect fit (e.g. facial disfigurement)
- Facial nerve damage which limits the ability to make facial expressions
- Body Mass Index (BMI) >29.9 which we deem may affect physical mobility
Trial locations and contacts
1 site in 1 country.
About this study
The primary aim of this project is to test if OCOsense glasses can function as a digital phenotyping tool derived from behavioural and physiological signals related to facial expression and motion recorded using the glasses.
Read the detailed description
Assessment of participants living with a DSM5 research diagnosis of Bipolar disorder or Major depressive disorder as well as healthy controls who will be recruited and characterised through precision phenotyping involving cross-sectional assessment of biobehavioural and physiological markers of the symptoms of depression. Correlations between objective (i.e., OCOsense glasses captured) and subjective (i.e., self-reported) symptoms of depression will be measured within as well as across diagnoses. The resulting biobehavioral clusters will form the building block of a digital phenotyping tool based upon the wider spectrum of non-verbal behaviours and physiology defined and affected by the phenotype of depression.
- Being tested
- OCOsense
- Keywords
- Digital phenotyping, Emotion, OCOSense, Wearables, Multimodal
- Medical subject headings
- Depressive Disorder, Major, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCOsenseDevice
Volunteers wear OCOsense glasses continuously during testing to monitor biobehavioural responses to tasks
| Study group | Role | What they receive |
|---|---|---|
| Clinical Cases | Participants wear OCOsense during mood induction tasks tracking hedonic, self-reflective and autobiographical processes respectively. Participants also wear OCOsense whilst engaging in simple physical activities. Receives: Device: OCOsense | |
| Control Cases | Participants wear OCOsense during mood induction tasks tracking hedonic, self-reflective and autobiographical processes respectively. Participants also wear OCOsense whilst engaging in simple physical activities. Receives: Device: OCOsense |
What is being measured
The primary outcome is the main question the study is designed to answer.
The demonstration of a significant association between facial expression-derived objective valence and self-reported subjective mood under controlled exposure
Measures of facial muscular activation in the corrugator supercilli and zygomaticus major muscles. By comparing the ratio of corrugator to zygomatic muscle activation, the OCOsense glasses will produce:
- Objective valence at a given time (ratio/intensity of corrugator to zygomatic muscle activation at that time).
Measured: 4 hours
The demonstration of a significant association between facial expression derived objective mood and self-reported subjective mood under controlled exposure
Measures of facial muscular activation in the corrugator supercilli and zygomaticus major muscles. By measuring corrugator and zygomatic muscle activation, the OCOsense glasses will produce:
- Objective mood during negatively valenced exposures, neutrally valenced exposures and positively valenced exposures described in terms of expression intensity and variability for each exposure.
Measured: 4 hours
Identifying physical activity engagement.
The OCOsense glasses contain Inertial Measurement Units (IMU) sensors. By detecting inertial displacement over time OCOsense will detect:
- Movement: a measure of movement over a period of time - specifically, how much of the time period is spent (i) stationary, (ii) in motion, (iii) fidgeting, (iv) engaging with a variety of activities of daily living
Measured: 2 hours
Secondary outcomes (1)
Investigating the relationship between vocal prosody and self-reported subjective mood
The OCOsense glasses contain a microphone. By detecting vocal parameters over time OCOsense will detect:
- the nonsemantic lexical features of speech related to pitch and tone whilst participants verbally recall a positive event in their life or engage with a semi-structured diagnostic interview.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start15 Jul 2022
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emteq Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charles Nduka, MA, MD, FRCS, Study director, Emteq CSO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05815459
- Sponsor's protocol ID
- MOOD
- Acronym
- MOOD
- Status last verified
- May 2023
- First submitted
- 23 Mar 2023
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Where possible, fully anonymised data will be hosted on a secure data responsibility. Specific details will be updated.
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Observation Of Depression
- ClinicalTrials.gov ID
- NCT05815459
- Acronym / sponsor ID
- MOOD / MOOD
- Keywords
- Digital phenotyping, Emotion, OCOSense, Wearables, Multimodal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Emteq LtdIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 18 Apr 2023 (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.
The primary aim of this project is to test if OCOsense glasses can function as a digital phenotyping tool derived from behavioural and physiological signals related to facial expression and motion recorded using the glasses.
Detailed description
Assessment of participants living with a DSM5 research diagnosis of Bipolar disorder or Major depressive disorder as well as healthy controls who will be recruited and characterised through precision phenotyping involving cross-sectional assessment of biobehavioural and physiological markers of the symptoms of depression. Correlations between objective (i.e., OCOsense glasses captured) and subjective (i.e., self-reported) symptoms of depression will be measured within as well as across diagnoses. The resulting biobehavioral clusters will form the building block of a digital phenotyping tool based upon the wider spectrum of non-verbal behaviours and physiology defined and affected by the phenotype of depression.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical Cases | – | Device: OCOsenseParticipants wear OCOsense during mood induction tasks tracking hedonic, self-reflective and autobiographical processes respectively. Participants also wear OCOsense whilst engaging in simple physical activities. |
| Control Cases | – | Device: OCOsenseParticipants wear OCOsense during mood induction tasks tracking hedonic, self-reflective and autobiographical processes respectively. Participants also wear OCOsense whilst engaging in simple physical activities. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Age groups
- Adult
- Study population
- Convenience sampling of young adults.
Key inclusion criteria (5 listed)
- Ability to read \& understand English. This is because the majority of our questionnaires are validated in the English language only.
- Able to walk, sit, lay and stand unaided
- ● ≥ 15 on the Patient health Questionnaire-9 (PhQ9) (moderate to severe depression)
Key exclusion criteria (10 listed)
- Self-reported current or past history (suspected or diagnosed) of any psychiatric condition
- <5 on the Generalised Anxiety Disorder-7 questionnaire (GAD-7)
- <5 on the PhQ-9 (no depression)
- Receiving medication for any psychiatric disorder (excluding fibromyalgia)
- < 18 years of age or >40 years of age
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 |
|---|---|---|
| OCOsenseVolunteers wear OCOsense glasses continuously during testing to monitor biobehavioural responses to tasks | Device | Clinical Cases, Control Cases |
Primary outcome
The demonstration of a significant association between facial expression-derived objective valence and self-reported subjective mood under controlled exposure
Time frame: 4 hours
Measures of facial muscular activation in the corrugator supercilli and zygomaticus major muscles. By comparing the ratio of corrugator to zygomatic muscle activation, the OCOsense glasses will produce: - Objective valence at a given time (ratio/intensity of corrugator to zygomatic muscle activation at that time).
The demonstration of a significant association between facial expression derived objective mood and self-reported subjective mood under controlled exposure
Time frame: 4 hours
Measures of facial muscular activation in the corrugator supercilli and zygomaticus major muscles. By measuring corrugator and zygomatic muscle activation, the OCOsense glasses will produce: - Objective mood during negatively valenced exposures, neutrally valenced exposures and positively valenced exposures described in terms of expression intensity and variability for each exposure.
Identifying physical activity engagement.
Time frame: 2 hours
The OCOsense glasses contain Inertial Measurement Units (IMU) sensors. By detecting inertial displacement over time OCOsense will detect: - Movement: a measure of movement over a period of time - specifically, how much of the time period is spent (i) stationary, (ii) in motion, (iii) fidgeting, (iv) engaging with a variety of activities of daily living
1 secondary outcome
Investigating the relationship between vocal prosody and self-reported subjective mood
Time frame: 2 hours
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 9 May 2023.
- Individual participant dataSharing planned: Undecided. Where possible, fully anonymised data will be hosted on a secure data responsibility. Specific details will be updated.
Related trials for Major Depressive Disorder
RecruitingPhase 1
Open-Label Psilocybin Study in Transdiagnostic Population
Transdiagnostic, Depression - Major Depressive Disorder
Not yet recruitingPhase 2
Assessing of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies
PTSD, PTSD - Post Traumatic Stress Disorder
RecruitingPhase 2
A Study to Evaluate TNX-102 SL Monotherapy Versus Placebo in Participants With Major Depressive Disorder (MDD)
Major Depressive Episode (MDE), Major Depressive Disorder (MDD)
RecruitingPhase 1
Mechanism of Action Underlying Ketamine's Antidepressant Effects: The AMPA Throughput Theory in Patients With Treatment-Resistant Major Depression
Depression, Major Depressive Disorder
Not yet recruiting
Acceptance and Committment Therapy Combined With Ketamine in Difficult-to-Treat Depression.
Major Depressive Disorder (MDD)
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.
Charles Nduka, MA, MD, FRCS study director
Emteq CSO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder and Major Depressive Episode, run by Emteq Ltd at 1 site in United Kingdom.
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 5 inclusion and 10 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 9 May 2023. 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 United Kingdom. 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?
The demonstration of a significant association between facial expression-derived objective valence and self-reported subjective mood under controlled exposure (time frame: 4 hours). The study lists 3 primary outcomes in all. 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 9 May 2023.