Major Depressive DisorderNCT06159595
Behavioral and Neuronal Correlates of Human Mood States
An observational study of Major Depressive Disorder and Epilepsy, run by Stanford University at 1 site in United States.
Trial summary
Optimizing treatments in mental health requires an easy to obtain, continuous, and objective measure of internal mood. Unfortunately, current standard-of-care clinical scales are sparsely sampled, subject to recency bias, underutilized, and are not validated for acute mood monitoring. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder, Epilepsy, Mood
- What is being tested?
- Intracranial EEG monitoring with audio-video recording
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2023to 7 Nov 2025
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adults with medically intractable epilepsy undergoing clinically indicated inpatient intracranial EEG monitoring at Stanford Health Care between December 2023 and July 2024.
Who may be able to join
- Age range between 18 and 65
- Major depressive disorder (MDD) in a current major depressive episode diagnosed with the Mini-International Neuropsychiatric Interview (MINI)
- No medical or surgical contraindication to electrode implantation
- Patient capable of understanding the scope of our project or signing informed consent independently.
Who cannot join
- Diffuse epilepsy involving several lobes of the brain
Trial locations and contacts
1 site in 1 country.
About this study
Optimizing treatments in mental health requires an easy to obtain, continuous, and objective measure of internal mood. Unfortunately, current standard-of-care clinical scales are sparsely sampled, subject to recency bias, underutilized, and are not validated for acute mood monitoring. The recent shift to remote care also requires novel methods to measure internal mood. Recent advances in computer vision have allowed the accurate quantification of observable speech patterns and facial representations. The continuous and objective nature of these audio-facial behavioral outputs also enable the study of their neural correlates. Here, the investigators hypothesize that video-derived audio-facial behaviors have discrete neural representations in the limbic network and can provide a critical set of reliable longitudinal estimates of mood at low cost across home and clinic settings.
- Conditions
- Major Depressive Disorder, Epilepsy, Mood
- Being tested
- Intracranial EEG monitoring with audio-video recording
- Medical subject headings
- Depressive Disorder, Major, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracranial EEG monitoring with audio-video recordingOther
Clinically indicated inpatient intracranial EEG monitoring with continuous audio-video recording and repeated self-reported mood ratings. No research direct electrical stimulation or sham stimulation was administered.
| Study group | Role | What they receive |
|---|---|---|
| Intracranial EEG monitoring with audio-video recording | Adults with medically intractable epilepsy who underwent inpatient intracranial EEG monitoring with continuous audio-video recording and repeated self-reported mood ratings. No participant received research direct electrical stimulation or sham stimulation. Receives: Other: Intracranial EEG monitoring with audio-video recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between Audio-Facial and Mood Change
Quantitative audio facial changes will be compared to quantitative changes in mood at each site by means of correlation and binary comparisons.
Measured: Every two hours during inpatient monitoring stay
Qualitative Mood Change
Qualitative articulation of mood by participants during inpatient monitoring stay. Speech transcripts will be analyzed for ratio of positive and negative valence words.
Measured: Every two hours during inpatient monitoring stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start1 Dec 2023
- Primary completion7 Nov 2025
- Study completion7 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Corey Keller, Stanford University
- Investigators
- Corey Keller, MD/PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06159595
- Sponsor's protocol ID
- 11354-2
- Other IDs
- 1R21MH134172
- Status last verified
- Oct 2026
- First submitted
- 16 Nov 2023
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified demographic, intracranial EEG, and behavioral data from all participants, shared through the NIMH Data Archive (NDA).
Publications
Kakusa B, Gopal JR, Forman L, Hartford JW, Brennan T, Pantis S, Persad AR, Cline CC, Buch VP, Parvizi J, Huang Y, Keller CJ. Distinct neural temporal architectures encode rapid social expressions and sustained internal mood states. bioRxiv [Preprint]. 2025 Dec 21:2025.12.20.692681. doi: 10.64898/2025.12.20.692681.
PubMed 41446192
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral and Neuronal Correlates of Human Mood States
- ClinicalTrials.gov ID
- NCT06159595
- Acronym / sponsor ID
- 11354-2
- Conditions
- Major Depressive Disorder, Epilepsy, Mood
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 7 Nov 2025 (actual)
- Study completion
- 7 Nov 2025 (actual)
- First posted
- 7 Dec 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.
Optimizing treatments in mental health requires an easy to obtain, continuous, and objective measure of internal mood. Unfortunately, current standard-of-care clinical scales are sparsely sampled, subject to recency bias, underutilized, and are not validated for acute mood monitoring. The recent shift to remote care also requires novel methods to measure internal mood. Recent advances in computer vision have allowed the accurate quantification of observable speech patterns and facial representations. The continuous and objective nature of these audio-facial behavioral outputs also enable the study of their neural correlates. Here, the investigators hypothesize that video-derived audio-facial behaviors have discrete neural representations in the limbic network and can provide a critical set of reliable longitudinal estimates of mood at low cost across home and clinic settings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intracranial EEG monitoring with audio-video recording | – | Other: Intracranial EEG monitoring with audio-video recordingAdults with medically intractable epilepsy who underwent inpatient intracranial EEG monitoring with continuous audio-video recording and repeated self-reported mood ratings. No participant received research direct electrical stimulation or sham stimulation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with medically intractable epilepsy undergoing clinically indicated inpatient intracranial EEG monitoring at Stanford Health Care between December 2023 and July 2024.
Key inclusion criteria (4 listed)
- Age range between 18 and 65
- Major depressive disorder (MDD) in a current major depressive episode diagnosed with the Mini-International Neuropsychiatric Interview (MINI)
- No medical or surgical contraindication to electrode implantation
- Patient capable of understanding the scope of our project or signing informed consent independently.
Key exclusion criteria (1 listed)
- Diffuse epilepsy involving several lobes of the brain
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 |
|---|---|---|
| Intracranial EEG monitoring with audio-video recordingClinically indicated inpatient intracranial EEG monitoring with continuous audio-video recording and repeated self-reported mood ratings. No research direct electrical stimulation or sham stimulation was administered. | Other | Intracranial EEG monitoring with audio-video recording |
Primary outcome
Correlation between Audio-Facial and Mood Change
Time frame: Every two hours during inpatient monitoring stay
Quantitative audio facial changes will be compared to quantitative changes in mood at each site by means of correlation and binary comparisons.
Qualitative Mood Change
Time frame: Every two hours during inpatient monitoring stay
Qualitative articulation of mood by participants during inpatient monitoring stay. Speech transcripts will be analyzed for ratio of positive and negative valence words.
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 2 Nov 2026.
- Results publication: PubMed 41446192Kakusa B, Gopal JR, Forman L, Hartford JW, Brennan T, Pantis S, Persad AR, Cline CC, Buch VP, Parvizi J, Huang Y, Keller CJ. Distinct neural temporal architectures encode rapid social expressions and sustained internal mood states. bioRxiv [Preprint]. 2025 Dec 21:2025.12.20.692681. doi: 10.64898/2025.12.20.692681.
- Individual participant dataSharing planned: Yes. De-identified demographic, intracranial EEG, and behavioral data from all participants, shared through the NIMH Data Archive (NDA).
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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.
Corey Keller, MD/PhD principal investigator
Stanford University
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 Epilepsy, run by Stanford University at 1 site in United States.
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 1 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 2 Nov 2026. 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 States. 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?
Correlation between Audio-Facial and Mood Change (time frame: Every two hours during inpatient monitoring stay). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06159595, which also lists 1 linked publication.
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 2 Nov 2026.