Major Depressive DisorderNCT05680220
40 Hz Light Neurostimulation for Patients With Depression (FELIX)
A study testing Neurostimulation System (NSS): Active Setting in people with Major Depressive Disorder and Treatment Resistant Depression, run by Klaus Martiny at 1 site in Denmark.
Trial summary
Recent research in mice models of Alzheimer's disease (AD) has demonstrated that one hour per day of exposure to 40 Hz flickering light therapy can halt the disease's progression, and improve cognition and memory. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Major Depressive Disorder, Treatment Resistant Depression
- What is being tested?
- Neurostimulation System (NSS): Active Setting
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 5 Oct 2023to 30 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects between 18 and 75 years of age.
- Subjects with a diagnosis of major depressive episode and currently experiencing a depressive episode according to DSM-5
- Subjects with an MDI score \> 21 at screening
- Subjects on stable medication and/or psychotherapy for at least 4 weeks before starting the trial.
- Subjects, who are willing to comply with the scheduled plan and are able to use the device for 1 hour per day for 6 weeks.
- Subjects who can understand the oral and written study information and willing to sign an informed consent.
Who cannot join
- Subjects with a history of photosensitive migraines and/or epileptic seizures
- Subjects with a known eye disorder that might be sensitive to light treatment.
- Subjects with a known history of bipolar disorder according to DSM-5 criteria
- Subjects with suicidal ideation corresponding to a score of 2 or more on the HAM-D 17 scale item 3 or if the patient or investigator is uncertain of the degree of suicidal risk
- Subjects with current psychotic symptoms. However, subjects with a prior psychotic depression or subjects with an actual psychotic depression episode that at the time of informed consent no longer fulfills the psychosis criteria are allowed to participate.
- Subjects with current drug or alcohol dependence based on their medical records or the M.I.N.I. interview.
Show all 11Show fewer
- Subjects with a known history of borderline personality disorder
- Subjects currently enrolled in another investigational treatment study.
- Subjects with progressive neurodegenerative or neoplastic disease.
- Subjects who are unable to understand the study procedures or handling of the NSS device.
- Subjects who are pregnant at the time of inclusion or unsafe contraception in women of fertile age
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malina Ploug Larsen contact
Denmark1 site, 1 recruiting
- Recruiting
Mental Health Centre Copenhagen
Copenhagen, Denmark, 2100
Klaus Martiny, DMsc, 0045-38647100, klaus.martiny@regionh.dk
About this study
Official title: A Double-blinded, Randomized Placebo-controlled Trial of 40 Hz Light Neurostimulation Therapy for Patients With Depression
Recent research in mice models of Alzheimer's disease (AD) has demonstrated that one hour per day of exposure to 40 Hz flickering light therapy can halt the disease's progression, and improve cognition and memory. Moreover, recent data suggest that 40 Hz light stimulation may induce neuroplasticity and reduce neuroinflammation.
In this study, the investigators aim to evaluate the antidepressant effects of 40 Hz light stimulation in Major Depressive Disorder (MDD). Patients will be exposed to 40 Hz invisible spectral flickering light (active setting) or continuous non-flickering white light (sham setting) in a home setting for 1 hour each day.
Read the detailed description
Major depression is a major societal challenge worldwide and a substantial proportion of patients do not attain remission. Major depressive disorder (MDD) bears several key neurobiological similarities with Alzheimer's Disease, namely cognitive deficits, impaired neuroplasticity, neurodegeneration, and neuroinflammation. Inducing neuroplasticity and reducing neuroinflammation are thought to be key cellular targets in the treatment of MDD. However, 40 Hz light stimulation research in the context of MDD is limited.
In this double-blinded, randomized placebo-controlled trial the primary objective is to investigate the antidepressant effect of a non-invasive neurostimulation therapy using a 40 Hz masked flickering light. This study utilizes a novel way of masking light by alternating the spectral composition of white light, resulting in the flicker unnoticeable to human perception.
The primary outcome measure of this study is the estimated difference in the Hamilton Depression Rating sub-scale (HAM-D6) scores between groups at week 6. Furthermore, investigators want to assess whether 40 Hz masked flickering light therapy produces a similar early shift in neural and cognitive response to emotional information seen with antidepressant therapy and whether this predicts treatment efficacy. Suicidal ideation, sleep patterns, and quality of life will be also investigated in order to evaluate the 40 Hz masked flickering light stimulation effects on other symptoms of depression. Explorative analysis of the EEG data will be performed from baseline to week 6 for the further development and validation of EEG-based biomarkers.
A total of 60 participants will be enrolled for a six weeks treatment period followed by a two weeks follow-up period. Participants will be recruited from a psychotherapeutic outpatient unit. Medication should be unchanged for the last 4 weeks and during the study period.
- Being tested
- Neurostimulation System (NSS): Active Setting, Neurostimulation System (NSS): Sham Setting
- Keywords
- 40 Hz stimulation, Major Depressive Disorder, Light therapy, GENUS
- Medical subject headings
- Depressive Disorder, Major, Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurostimulation System (NSS): Active SettingDevice
Exposure to the active device for 1 hour a day for 6 weeks
Neurostimulation System (NSS): Sham SettingDevice
Exposure to the sham device for 1 hour a day for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Active Neurostimulation System (NSS) | Experimental | Exposure to the NSS device set to 40 Hz invisible spectral flicker 1 hour a day |
| Sham Neurostimulation System (NSS) | Placebo comparator | Exposure to the NSS device set to continuous color-matched white light for 1 hour a day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression severity measured by Hamilton Depression Rating sub-scale (HAM-D6)
The HAM-D6 scale is designed to rate the severity of depression by a healthcare professional. The assessment scale contains 6 items pertaining to the symptoms of depression experienced over the week. The primary endpoint is the mean difference in scores between treatments at baseline and week 6. The score range is from, 0-24 (24=highest depression level).
Measured: Baseline and week 6
Secondary outcomes (9)
Self-reported depression symptoms measured by Major Depression Inventory (MDI)
The MDI is a depression self-assessment questionnaire. It consists of the 10 ICD-10 symptoms for depression. The sum of 10 questions indicates the degree of depression. The score range is from 0-50 (50=highest depression level).
Measured: Baseline, week 1, 3, 6 and 8.
Cognition measured by Facial Expression Recognition Test (FERT)
Assessing attention and recognition of emotional facial expressions using the FERT.
The outcome is accuracy (% correct expressions identified, range: 0-100, higher is better) and response times for accurate identifications (milliseconds, range can vary quite a bit, smaller number is better because it reflect higher speed).
Measured: Baseline, week 1 and 6
Cognition measured by Emotional Categorization and Memory test (ECMT)
Assessing self-referent memory for emotional words using the ECMT. Outcome is response times for correct identifications during encoding phase (milliseconds, smaller better) and for recall phase: number of positive and negative words recalled (higher is better)
Measured: Baseline, week 1 and 6
Cognition measured by Screen for Cognitive Impairment in Psychiatry (SCIP)
Non-emotional cognition is investigated with the SCIP. Outcomes is total score as well as scores for the five subtests, in all cases higher is better (numbers correct)
Measured: Baseline, week 1 and 6
Cognition measured by Trail Making Test B (TMT- B)
Non-emotional cognition investigated with the Trail Making Test B (TMT- B). Outcome is time in seconds to complete the task, lower is better (higher speed)
Measured: Baseline, week 1 and 6
Sleep quality measured by Pittsburgh Sleep Quality Index (PSQI)
PSQI consist of seven component scores that are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. A cut-off of 5 is recognized a indicative of sleep problems.
Measured: Baseline, week 3, 6 and 8
Sleep duration
Average sleep duration assessed over last 7 days will be logged by the participants using a sleep diary.
Measured: Baseline, week 3, 6 and 8
Sleep timing
Average sleep timing will be assessed over last 7 days logged by the participants using a sleep diary.
Measured: Baseline, week 3, 6 and 8
Quality of Life measured by WHO quality of life index (WHO-5)
The WHO-5 score ranges from 0 to 25, with 0 representing worst possible and 25 representing best possible quality of life. To obtain a percentage score ranging from 0 to 100, the raw score is multiplied by 4. A percentage score of 0 represents worst possible, whereas a score of 100 represents best possible quality of life. A 10% difference indicates a significant change.
Measured: Baseline, week 3,6 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start5 Oct 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Klaus Martiny
- Sponsor type
- University, hospital or other
- Collaborators
- Technical University of Denmark, OptoCeutics
- Responsible party
- Sponsor-investigator, Klaus Martiny, University Hospital Bispebjerg and Frederiksberg
- Investigators
- Klaus Martiny, Principal investigator, Senior Consultant at Psychiatric Centre Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05680220
- Sponsor's protocol ID
- FELIX
- Status last verified
- Feb 2026
- First submitted
- 3 Jan 2023
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Adaikkan C, Middleton SJ, Marco A, Pao PC, Mathys H, Kim DN, Gao F, Young JZ, Suk HJ, Boyden ES, McHugh TJ, Tsai LH. Gamma Entrainment Binds Higher-Order Brain Regions and Offers Neuroprotection. Neuron. 2019 Jun 5;102(5):929-943.e8. doi: 10.1016/j.neuron.2019.04.011. Epub 2019 May 7.
PubMed 31076275Chen X, Shi X, Wu Y, Zhou Z, Chen S, Han Y, Shan C. Gamma oscillations and application of 40-Hz audiovisual stimulation to improve brain function. Brain Behav. 2022 Dec;12(12):e2811. doi: 10.1002/brb3.2811. Epub 2022 Nov 14.
PubMed 36374520Cimenser A, Hempel E, Travers T, Strozewski N, Martin K, Malchano Z, Hajos M. Sensory-Evoked 40-Hz Gamma Oscillation Improves Sleep and Daily Living Activities in Alzheimer's Disease Patients. Front Syst Neurosci. 2021 Sep 24;15:746859. doi: 10.3389/fnsys.2021.746859. eCollection 2021.
PubMed 34630050Colgin LL, Moser EI. Gamma oscillations in the hippocampus. Physiology (Bethesda). 2010 Oct;25(5):319-29. doi: 10.1152/physiol.00021.2010.
PubMed 20940437Duman RS, Aghajanian GK, Sanacora G, Krystal JH. Synaptic plasticity and depression: new insights from stress and rapid-acting antidepressants. Nat Med. 2016 Mar;22(3):238-49. doi: 10.1038/nm.4050.
PubMed 26937618Fitzgerald PJ, Watson BO. Gamma oscillations as a biomarker for major depression: an emerging topic. Transl Psychiatry. 2018 Sep 4;8(1):177. doi: 10.1038/s41398-018-0239-y.
PubMed 30181587Godlewska BR, Harmer CJ. Cognitive neuropsychological theory of antidepressant action: a modern-day approach to depression and its treatment. Psychopharmacology (Berl). 2021 May;238(5):1265-1278. doi: 10.1007/s00213-019-05448-0. Epub 2020 Jan 15.
PubMed 31938879Martiny K, Lunde M, Unden M, Dam H, Bech P. Adjunctive bright light in non-seasonal major depression: results from clinician-rated depression scales. Acta Psychiatr Scand. 2005 Aug;112(2):117-25. doi: 10.1111/j.1600-0447.2005.00574.x.
PubMed 15992393Agger MP, Carstensen MS, Henney MA, Hansen LS, Baandrup AO, Nguyen M, Petersen PM, Madsen KH, Kjaer TW. Novel Invisible Spectral Flicker Induces 40 Hz Neural Entrainment with Similar Spatial Distribution as 40 Hz Stroboscopic Light. J Alzheimers Dis. 2022;88(1):335-344. doi: 10.3233/JAD-220081.
PubMed 35570490
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blinded, Randomized Placebo-controlled Trial of 40 Hz Light Neurostimulation Therapy for Patients With Depression
- ClinicalTrials.gov ID
- NCT05680220
- Acronym / sponsor ID
- FELIX
- Keywords
- 40 Hz stimulation, Major Depressive Disorder, Light therapy, GENUS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Klaus MartinyUniversity, hospital or other
- Collaborators
- Technical University of Denmark, OptoCeutics
- Study start
- 5 Oct 2023 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 11 Jan 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.
Recent research in mice models of Alzheimer's disease (AD) has demonstrated that one hour per day of exposure to 40 Hz flickering light therapy can halt the disease's progression, and improve cognition and memory. Moreover, recent data suggest that 40 Hz light stimulation may induce neuroplasticity and reduce neuroinflammation.
In this study, the investigators aim to evaluate the antidepressant effects of 40 Hz light stimulation in Major Depressive Disorder (MDD). Patients will be exposed to 40 Hz invisible spectral flickering light (active setting) or continuous non-flickering white light (sham setting) in a home setting for 1 hour each day.
Detailed description
Major depression is a major societal challenge worldwide and a substantial proportion of patients do not attain remission. Major depressive disorder (MDD) bears several key neurobiological similarities with Alzheimer's Disease, namely cognitive deficits, impaired neuroplasticity, neurodegeneration, and neuroinflammation. Inducing neuroplasticity and reducing neuroinflammation are thought to be key cellular targets in the treatment of MDD. However, 40 Hz light stimulation research in the context of MDD is limited.
In this double-blinded, randomized placebo-controlled trial the primary objective is to investigate the antidepressant effect of a non-invasive neurostimulation therapy using a 40 Hz masked flickering light. This study utilizes a novel way of masking light by alternating the spectral composition of white light, resulting in the flicker unnoticeable to human perception.
The primary outcome measure of this study is the estimated difference in the Hamilton Depression Rating sub-scale (HAM-D6) scores between groups at week 6. Furthermore, investigators want to assess whether 40 Hz masked flickering light therapy produces a similar early shift in neural and cognitive response to emotional information seen with antidepressant therapy and whether this predicts treatment efficacy. Suicidal ideation, sleep patterns, and quality of life will be also investigated in order to evaluate the 40 Hz masked flickering light stimulation effects on other symptoms of depression. Explorative analysis of the EEG data will be performed from baseline to week 6 for the further development and validation of EEG-based biomarkers.
A total of 60 participants will be enrolled for a six weeks treatment period followed by a two weeks follow-up period. Participants will be recruited from a psychotherapeutic outpatient unit. Medication should be unchanged for the last 4 weeks and during the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Neurostimulation System (NSS) | Experimental | –Exposure to the NSS device set to 40 Hz invisible spectral flicker 1 hour a day |
| Sham Neurostimulation System (NSS) | Placebo comparator | –Exposure to the NSS device set to continuous color-matched white light for 1 hour a day |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects between 18 and 75 years of age.
- Subjects with a diagnosis of major depressive episode and currently experiencing a depressive episode according to DSM-5
- Subjects with an MDI score \> 21 at screening
- Subjects on stable medication and/or psychotherapy for at least 4 weeks before starting the trial.
- Subjects, who are willing to comply with the scheduled plan and are able to use the device for 1 hour per day for 6 weeks.
Key exclusion criteria (11 listed)
- Subjects with a history of photosensitive migraines and/or epileptic seizures
- Subjects with a known eye disorder that might be sensitive to light treatment.
- Subjects with a known history of bipolar disorder according to DSM-5 criteria
- Subjects with suicidal ideation corresponding to a score of 2 or more on the HAM-D 17 scale item 3 or if the patient or investigator is uncertain of the degree of suicidal risk
- Subjects with current psychotic symptoms. However, subjects with a prior psychotic depression or subjects with an actual psychotic depression episode that at the time of informed consent no longer fulfills the psychosis criteria are allowed to participate.
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 |
|---|---|---|
| Neurostimulation System (NSS): Active SettingExposure to the active device for 1 hour a day for 6 weeks | Device | – |
| Neurostimulation System (NSS): Sham SettingExposure to the sham device for 1 hour a day for 6 weeks | Device | – |
Primary outcome
Depression severity measured by Hamilton Depression Rating sub-scale (HAM-D6)
Time frame: Baseline and week 6
The HAM-D6 scale is designed to rate the severity of depression by a healthcare professional. The assessment scale contains 6 items pertaining to the symptoms of depression experienced over the week. The primary endpoint is the mean difference in scores between treatments at baseline and week 6. The score range is from, 0-24 (24=highest depression level).
9 secondary outcomes
Self-reported depression symptoms measured by Major Depression Inventory (MDI)
Time frame: Baseline, week 1, 3, 6 and 8.
Cognition measured by Facial Expression Recognition Test (FERT)
Time frame: Baseline, week 1 and 6
Cognition measured by Emotional Categorization and Memory test (ECMT)
Time frame: Baseline, week 1 and 6
Cognition measured by Screen for Cognitive Impairment in Psychiatry (SCIP)
Time frame: Baseline, week 1 and 6
Cognition measured by Trail Making Test B (TMT- B)
Time frame: Baseline, week 1 and 6
Sleep quality measured by Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline, week 3, 6 and 8
Sleep duration
Time frame: Baseline, week 3, 6 and 8
Sleep timing
Time frame: Baseline, week 3, 6 and 8
Quality of Life measured by WHO quality of life index (WHO-5)
Time frame: Baseline, week 3,6 and 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Background: PubMed 31076275Adaikkan C, Middleton SJ, Marco A, Pao PC, Mathys H, Kim DN, Gao F, Young JZ, Suk HJ, Boyden ES, McHugh TJ, Tsai LH. Gamma Entrainment Binds Higher-Order Brain Regions and Offers Neuroprotection. Neuron. 2019 Jun 5;102(5):929-943.e8. doi: 10.1016/j.neuron.2019.04.011. Epub 2019 May 7.
- Background: PubMed 36374520Chen X, Shi X, Wu Y, Zhou Z, Chen S, Han Y, Shan C. Gamma oscillations and application of 40-Hz audiovisual stimulation to improve brain function. Brain Behav. 2022 Dec;12(12):e2811. doi: 10.1002/brb3.2811. Epub 2022 Nov 14.
- Background: PubMed 34630050Cimenser A, Hempel E, Travers T, Strozewski N, Martin K, Malchano Z, Hajos M. Sensory-Evoked 40-Hz Gamma Oscillation Improves Sleep and Daily Living Activities in Alzheimer's Disease Patients. Front Syst Neurosci. 2021 Sep 24;15:746859. doi: 10.3389/fnsys.2021.746859. eCollection 2021.
- Background: PubMed 20940437Colgin LL, Moser EI. Gamma oscillations in the hippocampus. Physiology (Bethesda). 2010 Oct;25(5):319-29. doi: 10.1152/physiol.00021.2010.
- Background: PubMed 26937618Duman RS, Aghajanian GK, Sanacora G, Krystal JH. Synaptic plasticity and depression: new insights from stress and rapid-acting antidepressants. Nat Med. 2016 Mar;22(3):238-49. doi: 10.1038/nm.4050.
- Background: PubMed 30181587Fitzgerald PJ, Watson BO. Gamma oscillations as a biomarker for major depression: an emerging topic. Transl Psychiatry. 2018 Sep 4;8(1):177. doi: 10.1038/s41398-018-0239-y.
- Background: PubMed 31938879Godlewska BR, Harmer CJ. Cognitive neuropsychological theory of antidepressant action: a modern-day approach to depression and its treatment. Psychopharmacology (Berl). 2021 May;238(5):1265-1278. doi: 10.1007/s00213-019-05448-0. Epub 2020 Jan 15.
- Background: PubMed 15992393Martiny K, Lunde M, Unden M, Dam H, Bech P. Adjunctive bright light in non-seasonal major depression: results from clinician-rated depression scales. Acta Psychiatr Scand. 2005 Aug;112(2):117-25. doi: 10.1111/j.1600-0447.2005.00574.x.
- Results publication: PubMed 35570490Agger MP, Carstensen MS, Henney MA, Hansen LS, Baandrup AO, Nguyen M, Petersen PM, Madsen KH, Kjaer TW. Novel Invisible Spectral Flicker Induces 40 Hz Neural Entrainment with Similar Spatial Distribution as 40 Hz Stroboscopic Light. J Alzheimers Dis. 2022;88(1):335-344. doi: 10.3233/JAD-220081.
- 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.
Malina Ploug Larsen contact
Klaus Martiny principal investigator
Senior Consultant at Psychiatric Centre Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurostimulation System (NSS): Active Setting in people with Major Depressive Disorder and Treatment Resistant Depression, run by Klaus Martiny at 1 site in Denmark.
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 6 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 3 Mar 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 Denmark. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Klaus Martiny (+45 38 64 71 00, klaus.martiny@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression severity measured by Hamilton Depression Rating sub-scale (HAM-D6) (time frame: Baseline and week 6). 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 NCT05680220, which also lists 9 linked publications.
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 3 Mar 2026.