40 Hz Light Neurostimulation for Patients With Depression (FELIX)

NCT05680220 | Recruiting DMC

• 1 other identifier: FELIX
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Treatment Resistant Depression; Major Depressive Disorder

Keywords

40 Hz stimulation; Major Depressive Disorder; Light therapy; GENUS

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline and week 6

Secondary Outcomes (9)

• Self-reported depression symptoms measured by Major Depression Inventory (MDI)

  Baseline, week 1, 3, 6 and 8.

• Cognition measured by Facial Expression Recognition Test (FERT)

  Baseline, week 1 and 6

• Cognition measured by Emotional Categorization and Memory test (ECMT)

  Baseline, week 1 and 6

• Cognition measured by Screen for Cognitive Impairment in Psychiatry (SCIP)

  Baseline, week 1 and 6

• Cognition measured by Trail Making Test B (TMT- B)

  Baseline, week 1 and 6

Study Arms (2)

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

Interventions

Neurostimulation System (NSS): Active Setting DEVICE

Exposure to the active device for 1 hour a day for 6 weeks

Neurostimulation System (NSS): Sham Setting DEVICE

Exposure to the sham device for 1 hour a day for 6 weeks

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Technical University of Denmark: collaborator
• OptoCeutics: collaborator
• Klaus Martiny: lead

Study Sites (1)

Mental Health Centre Copenhagen

Copenhagen, Denmark, 2100, Denmark

RECRUITING

Related Publications (9)

• 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.

  PMID: 31076275 BACKGROUND

• Chen 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.

  PMID: 36374520 BACKGROUND

• Cimenser 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.

  PMID: 34630050 BACKGROUND

• Colgin LL, Moser EI. Gamma oscillations in the hippocampus. Physiology (Bethesda). 2010 Oct;25(5):319-29. doi: 10.1152/physiol.00021.2010.

  PMID: 20940437 BACKGROUND

• Duman 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.

  PMID: 26937618 BACKGROUND

• Fitzgerald 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.

  PMID: 30181587 BACKGROUND

• Godlewska 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.

  PMID: 31938879 BACKGROUND

• Martiny 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.

  PMID: 15992393 BACKGROUND

• Agger 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.

  PMID: 35570490 RESULT

MeSH Terms

Conditions

Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Klaus Martiny

  Senior Consultant at Psychiatric Centre Copenhagen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Klaus Martiny

CONTACT

+45 38 64 71 00; klaus.martiny@regionh.dk

Malina Ploug Larsen

CONTACT

malina.ploug.larsen@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Head of NID-Group

Study Record Dates

• First Submitted: January 3, 2023
• First Posted: January 11, 2023
• Study Start: October 5, 2023
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): July 30, 2027
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)