Depression, UnipolarNCT05958940
BioClock: Bright Light Therapy for Depressive Disorders
A study testing Bright Light Therapy and Blue Light Blocking Glasses in people with Depression, Unipolar and Depression, Bipolar, run by Universiteit Leiden at 2 sites in Netherlands.
Trial summary
Bright Light Therapy (BLT) is a proven treatment for depression in seasonal and non-seasonal depressive disorders, as well as bipolar disorder. To make BLT more effective and practical in clinical settings and tailor it to individual needs, it is necessary to optimize the treatment approach, understand how the… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression, Unipolar, Depression, Bipolar
- What is being tested?
- Bright Light Therapy and Blue Light Blocking Glasses
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 231 participants
- Where
- 2 sitesNetherlands
- Study dates
- 8 Feb 2024to Dec 2026
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65.
- Diagnosis of unipolar or bipolar depression (seasonal or non-seasonal) as assessed with the Mini-International Neuropsychiatric Interview (M.I.N.I.)
- A current depressive episode (a score of 6 or higher on the Quick Inventory of depressive symptomatology Self Report (QIDS-SR)
- Sufficient knowledge of Dutch or English language to fill in questionnaires
- Provided Informed consent
Who cannot join
- A current (hypo)manic or mixed episode (as assessed with the M.I.N.I.)
- Current psychotic episode (as assessed with the M.I.N.I.)
- Prominent active suicidality (score 10 or higher on the M.I.N.I. module)
- Antidepressant therapy (medication, psychotherapy or BLT, or other forms of specific treatments for depression) that started less than 2 months prior to study entry
- participants with bipolar disorder should be in mood-stabilizing treatment for at least 1 month in a recommended dosage,
- Use of melatonin or agomelatine in the last month
Show all 17Show fewer
- Current use of antibiotics
- Current use of light sensitivity increasing medication
- Travelled across more than 1 time zone during past month or during the treatment
- Travelled to sunny holiday locations/winter sports during past month
- pre-existing eye and skin disorders (retinitis pigmentosa, porphyria, chronic actinic dermatitis and sun-induced urticaria)
- Systemic disorders with potential retinal involvement (rheumatoid arthritis and systemic lupus erythematosus)
- Suffering from colour blindness (assessed by Ishihara colour plates)
- Participated in night shift work in the last three months
- (Retinal) blindness, severe cataract and glaucoma
- Light-induced migraine or epilepsy
- Pregnancy, or parents with a child younger than 18 months old
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Luc Schlangen, PhD contact
Netherlands2 sites, 2 recruiting
- Recruiting
GGzE - Mental Health Institute of Eindhoven and the Kempen
Eindhoven, 5626 ND
Emma Visser, MSc, +31622143145, e.visser1@tue.nl
- Recruiting
Leids Universitair Behandel- en Expertise Centrum
Leiden, 5626 ND
Niki Antypa, PhD, +31 71 527 6677, nantypa@fsw.leidenuniv.nl
About this study
Official title: BioClock: Optimization, Working Mechanisms and Response Predictors of Bright Light Therapy for Depressive Disorders - a Multicentre Randomized Controlled Trial
Bright Light Therapy (BLT) is a proven treatment for depression in seasonal and non-seasonal depressive disorders, as well as bipolar disorder. To make BLT more effective and practical in clinical settings and tailor it to individual needs, it is necessary to optimize the treatment approach, understand how the treatment works, and identify patient characteristics that predict response.
This clinical trial has three main goals:
Read more
- Optimize the administration of BLT for patients with depressive episodes.
- Gain a deeper understanding of the treatment mechanisms.
- Determine which patients benefit the most from the treatment.
The specific objectives are as follows:
- Investigate whether additional treatments and interventions related to lifestyle and the biological clock can enhance the effects of BLT.
- Examine how BLT influences the body's internal clock and sleep quality, and how these factors contribute to the outcomes.
- Identify patient characteristics and behaviours that can predict treatment outcomes.
- Develop a brain model to better understand the impact of BLT on the brain.
In this study, patients will receive BLT with a light intensity of 10,000 lux for 30 minutes each morning over 5 consecutive days. The treatment duration will range from one to three weeks, depending on the improvement of depressive symptoms. Participants will be randomly assigned to one of three groups:
- Home - Patients will receive BLT at home, following the standard guidelines for light therapy in the Netherlands.
- LightCafé, fixed time: Patients will receive BLT in a café-like setting called the LightCafé, where the focus is not only on symptom improvement but also lifestyle enhancements and fostering social connections. The treatment time will be the same every day.
- LightCafé, varying time: Patients will also receive BLT at the LightCafé, with treatment timing varying each day. Additionally, this group will wear glasses in the evening that filter blue light.
The study includes a baseline phase of up to two weeks, a treatment phase of up to three weeks, and a three-month follow-up phase. Patients will wear a motion watch to assess sleep-wake behaviour and physical activity during the day. Additionally, they will wear a broach that measures their personal light exposure throughout the day. Eight one-minute questionnaires per day will be sent to the participants' smartphones to assess vitality, sleep, and mood during the treatment. Predictors of treatment response, such as clinical characteristics, sleep measures, circadian parameters, and light-related behaviours, will be evaluated at baseline. In a small group of patients, salivary melatonin curves will be assessed before and after treatment. MRI scans will provide insights into functional and structural brain changes following light therapy treatment.
- Conditions
- Depression, Unipolar, Depression, Bipolar
- Being tested
- Bright Light Therapy, Blue Light Blocking Glasses
- Keywords
- Depression, Bright Light Therapy, Chronotherapy, Circadian Rhythm, Sleep, Life Style, Ecological Momentary Assessment, Actigraphy, Dim light melatonin onset, Response predictors
- Medical subject headings
- Depressive Disorder, Bipolar Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bright Light TherapyProcedure or surgery
In this study, Bright Light Therapy (BLT) will be administered according to Dutch depression guidelines, using Innolux LED light lamp (3800K, 10,000 lux). BLT will be given for one work week (Mon-Fri), 7:30-10:30 AM, 30 mins/session. Patients can have breakfast, read, or use devices. Treatment effectiveness will be evaluated using Self-Rated Quick Inventory of Depressive Symptoms (QIDS-SR). If remission is achieved (QIDS-SR < 6), no additional treatment is given. If response is insufficient (QIDS-SR ≥ 6), 5 more sessions will be added in the following week, with maximum two extensions (1-3 weeks total).
Blue Light Blocking GlassesDevice
Plastic, orange-coloured glasses that primarily block blue light. To be worn in the evening.
| Study group | Role | What they receive |
|---|---|---|
| Light@Home | Active comparator | Standard Care - BLT in the home environment Receives: Procedure: Bright Light Therapy |
| LightCafé | Experimental | BLT will be administered in a specialized cafe, under the supervision of clinical staff, promoting lifestyle changes and social interaction. Receives: Procedure: Bright Light Therapy |
| LightCafé+ | Experimental | Treatment will be identical to the second arm but now complemented with the use of blue-light blocking glasses in the evening and the adoption of personalized BLT timing based on sleep-wake patterns Receives: Procedure: Bright Light Therapy; Device: Blue Light Blocking Glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Improvement
Difference between pre- and post-treatment assessment of the Montgomery Asberg Depression Rating Scale [MADRS]
Measured: 2-5 weeks
Secondary outcomes (17)
Subjective change in depressive symptom severity
Change in score on the Quick Inventory of Depressive Symptoms, Self Report (QIDS-SR)
Measured: from baseline until follow-up, approximately 4 months
Remission rates, self assessed and clinician rated
percentage of patients that after treatment have a score of <6 on the MADRS or QIDS-SR
Measured: 2-5 weeks for clinician rated. Up until 4 months after start treatment for self-assessed
Response Rates, self assessed and clinician rated
percentage of patients hat after treatment have at least 50% reduction in depressive symptom, measured using MADRS and QIDS-SR
Measured: 2-5 weeks for clinician rated, Up until 4 months after start treatment for self-assessed
Time to remission
The time it takes to achieve remission, if remission is achieved. Measured with QIDS-SR
Measured: one, two or three weeks
Circadian phase
Changes in circadian phase will be compared between groups as assessed using the DLMO (calculated from the melatonin assessments) and complemented with actigraphy data (using sleep onset timing, least active 5h period and most active 10h period)
Measured: 2-5 weeks
Circadian amplitude
Changes in the circadian amplitude will be compared between groups. The amplitude can be estimated from actigraphy data by the difference in activity between the most active 10h and the least active 5h normalized for total activity.
Measured: 2-5 weeks
Circadian Periodicity
Changes in circadian periodicity will be compared between groups. Circadian periodicity is a period of an oscillating rhythm assessed via periodogram analysis of the activity time-course of actigraphy data. The deviation between the maximum period of the periodogram and the normal daily period of 24h reflects pattern variability in normal entrainment conditions.
Measured: 2-5 weeks
Inter-daily stability
Constancy of the 24-h rhythmic pattern over days
Measured: 2-5 weeks
Intra-daily variability
rhythm fragmentation
Measured: 2-5 weeks
Chronotype
Chronotype changes as assessed with the Morningness-Eveningness Questionnaire(MEQ) and the Ultra-Short Version of the Munich Chronotype Questionnaire (µMCTQ)
Measured: 1-3 months
Sleep-Wake Pattern
Actigraphy and questions from The Consensus Sleep Diary will provide sleep onset time, sleep offset time, midsleep time, total sleep time, sleep onset latency, number of awakenings and time awake during the night.
Measured: 2-5 weeks
Sleep Quality
Fragmentation index (degree of movement during the night), sleep efficiency (total sleep time expressed as a percentage of time in bed) will be calculated using actigraphy data. The Pittsburgh Sleep Quality Index (PSQI) will provide a subjective measure of sleep quality.
Measured: 2-5 weeks for actigraphy, up until 4 months after the start of treatment for subjective sleep quality
Severity of Insomnia Symptoms
Severity of Insomnia Symptoms as assessed with the Insomnia Severity Index
Measured: up until 4 months after the starts of treatment
Momentary Positive/Negative Affect
The EMA will consist of items from the Positive and Negative Affect Scale (PANAS) to assess momentary positive and negative affect
Measured: 2-5 weeks
Momentary Vitality
The EMA will contain 4 items concerning energy levels and alertness adapted from Activation-Deactivation Adjective Checklist
Measured: 2-5 weeks
Gray matter structure
Properties of gray matter structure (thickness, volume, surface area and gyrification) of the whole brain as well as of the white matter structure (integrity of main white matter fiber tracts-fractional anisotropy (FA))
Measured: 2-5 weeks
Functional connectivity of the brain
Functional connectivity of the brain under resting state condition - the communication of specific brain regions which work as a network without conducting a specific task
Measured: 2-5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start8 Feb 2024
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
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 Depression, UnipolarStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 231 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiteit Leiden
- Sponsor type
- University, hospital or other
- Collaborators
- Eindhoven University of Technology, Geestelijke Gezondheidszorg Eindhoven (GGzE), Chrono@Work B.V.
- Responsible party
- Principal investigator, Niki Antypa, Universiteit Leiden
- Investigators
- Niki Antypa, PhD, Principal investigator, Leiden University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05958940
- Sponsor's protocol ID
- NL83497.058.23
- Status last verified
- Jan 2025
- First submitted
- 7 Jul 2023
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data underlying a publication can be shared upon request.
Publications
Visser E, Rus-Oswald OG, van der Does AJW, Gordijn MCM, Marcelis MC, de Kort YAW, Oomen PP, Schlangen LJM, Seetsen T, Simons CJP, Antypa N. BioClock-optimizing Bright Light Therapy for adults with depression: a study protocol for a multicenter randomized clinical trial on treatment strategies, response predictors, and chronobiological and neurobiological mechanisms. Trials. 2025 Oct 14;26(1):411. doi: 10.1186/s13063-025-08984-7.
PubMed 41088238
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BioClock: Optimization, Working Mechanisms and Response Predictors of Bright Light Therapy for Depressive Disorders - a Multicentre Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05958940
- Acronym / sponsor ID
- NL83497.058.23
- Conditions
- Depression, Unipolar, Depression, Bipolar
- Keywords
- Depression, Bright Light Therapy, Chronotherapy, Circadian Rhythm, Sleep, Life Style, Ecological Momentary Assessment, Actigraphy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 231 participants (estimated)
- Lead sponsor
- Universiteit LeidenUniversity, hospital or other
- Collaborators
- Eindhoven University of Technology, Geestelijke Gezondheidszorg Eindhoven (GGzE), Chrono@Work B.V.
- Study start
- 8 Feb 2024 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 25 Jul 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.
Bright Light Therapy (BLT) is a proven treatment for depression in seasonal and non-seasonal depressive disorders, as well as bipolar disorder. To make BLT more effective and practical in clinical settings and tailor it to individual needs, it is necessary to optimize the treatment approach, understand how the treatment works, and identify patient characteristics that predict response.
This clinical trial has three main goals:
- Optimize the administration of BLT for patients with depressive episodes.
- Gain a deeper understanding of the treatment mechanisms.
- Determine which patients benefit the most from the treatment.
The specific objectives are as follows:
- Investigate whether additional treatments and interventions related to lifestyle and the biological clock can enhance the effects of BLT.
- Examine how BLT influences the body's internal clock and sleep quality, and how these factors contribute to the outcomes.
- Identify patient characteristics and behaviours that can predict treatment outcomes.
- Develop a brain model to better understand the impact of BLT on the brain.
In this study, patients will receive BLT with a light intensity of 10,000 lux for 30 minutes each morning over 5 consecutive days. The treatment duration will range from one to three weeks, depending on the improvement of depressive symptoms. Participants will be randomly assigned to one of three groups:
- Home - Patients will receive BLT at home, following the standard guidelines for light therapy in the Netherlands.
- LightCafé, fixed time: Patients will receive BLT in a café-like setting called the LightCafé, where the focus is not only on symptom improvement but also lifestyle enhancements and fostering social connections. The treatment time will be the same every day.
- LightCafé, varying time: Patients will also receive BLT at the LightCafé, with treatment timing varying each day. Additionally, this group will wear glasses in the evening that filter blue light.
The study includes a baseline phase of up to two weeks, a treatment phase of up to three weeks, and a three-month follow-up phase. Patients will wear a motion watch to assess sleep-wake behaviour and physical activity during the day. Additionally, they will wear a broach that measures their personal light exposure throughout the day. Eight one-minute questionnaires per day will be sent to the participants' smartphones to assess vitality, sleep, and mood during the treatment. Predictors of treatment response, such as clinical characteristics, sleep measures, circadian parameters, and light-related behaviours, will be evaluated at baseline. In a small group of patients, salivary melatonin curves will be assessed before and after treatment. MRI scans will provide insights into functional and structural brain changes following light therapy treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Light@Home | Active comparator | Procedure: Bright Light TherapyStandard Care - BLT in the home environment |
| LightCafé | Experimental | Procedure: Bright Light TherapyBLT will be administered in a specialized cafe, under the supervision of clinical staff, promoting lifestyle changes and social interaction. |
| LightCafé+ | Experimental | Procedure: Bright Light Therapy, Device: Blue Light Blocking GlassesTreatment will be identical to the second arm but now complemented with the use of blue-light blocking glasses in the evening and the adoption of personalized BLT timing based on sleep-wake patterns |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 65.
- Diagnosis of unipolar or bipolar depression (seasonal or non-seasonal) as assessed with the Mini-International Neuropsychiatric Interview (M.I.N.I.)
- A current depressive episode (a score of 6 or higher on the Quick Inventory of depressive symptomatology Self Report (QIDS-SR)
- Sufficient knowledge of Dutch or English language to fill in questionnaires
- Provided Informed consent
Key exclusion criteria (17 listed)
- A current (hypo)manic or mixed episode (as assessed with the M.I.N.I.)
- Current psychotic episode (as assessed with the M.I.N.I.)
- Prominent active suicidality (score 10 or higher on the M.I.N.I. module)
- Antidepressant therapy (medication, psychotherapy or BLT, or other forms of specific treatments for depression) that started less than 2 months prior to study entry
- participants with bipolar disorder should be in mood-stabilizing treatment for at least 1 month in a recommended dosage,
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 |
|---|---|---|
| Bright Light TherapyIn this study, Bright Light Therapy (BLT) will be administered according to Dutch depression guidelines, using Innolux LED light lamp (3800K, 10,000 lux). BLT will be given for one work week (Mon-Fri), 7:30-10:30 AM, 30 mins/session. Patients can have breakfast, read, or use devices. Treatment effectiveness will be evaluated using Self-Rated Quick Inventory of Depressive Symptoms (QIDS-SR). If remission is achieved (QIDS-SR < 6), no additional treatment is given. If response is insufficient (QIDS-SR ≥ 6), 5 more sessions will be added in the following week, with maximum two extensions (1-3 weeks total). | Procedure or surgery | Light@Home, LightCafé, LightCafé+ |
| Blue Light Blocking GlassesPlastic, orange-coloured glasses that primarily block blue light. To be worn in the evening. | Device | LightCafé+ |
Primary outcome
Clinical Improvement
Time frame: 2-5 weeks
Difference between pre- and post-treatment assessment of the Montgomery Asberg Depression Rating Scale [MADRS]
17 secondary outcomes
Subjective change in depressive symptom severity
Time frame: from baseline until follow-up, approximately 4 months
Remission rates, self assessed and clinician rated
Time frame: 2-5 weeks for clinician rated. Up until 4 months after start treatment for self-assessed
Response Rates, self assessed and clinician rated
Time frame: 2-5 weeks for clinician rated, Up until 4 months after start treatment for self-assessed
Time to remission
Time frame: one, two or three weeks
Circadian phase
Time frame: 2-5 weeks
Circadian amplitude
Time frame: 2-5 weeks
Circadian Periodicity
Time frame: 2-5 weeks
Inter-daily stability
Time frame: 2-5 weeks
Intra-daily variability
Time frame: 2-5 weeks
Chronotype
Time frame: 1-3 months
Sleep-Wake Pattern
Time frame: 2-5 weeks
Sleep Quality
Time frame: 2-5 weeks for actigraphy, up until 4 months after the start of treatment for subjective sleep quality
Severity of Insomnia Symptoms
Time frame: up until 4 months after the starts of treatment
Momentary Positive/Negative Affect
Time frame: 2-5 weeks
Momentary Vitality
Time frame: 2-5 weeks
Gray matter structure
Time frame: 2-5 weeks
Functional connectivity of the brain
Time frame: 2-5 weeks
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 9 Jan 2025.
- Derived from this study: PubMed 41088238Visser E, Rus-Oswald OG, van der Does AJW, Gordijn MCM, Marcelis MC, de Kort YAW, Oomen PP, Schlangen LJM, Seetsen T, Simons CJP, Antypa N. BioClock-optimizing Bright Light Therapy for adults with depression: a study protocol for a multicenter randomized clinical trial on treatment strategies, response predictors, and chronobiological and neurobiological mechanisms. Trials. 2025 Oct 14;26(1):411. doi: 10.1186/s13063-025-08984-7.
- Individual participant dataSharing planned: Yes. All data underlying a publication can be shared upon request.
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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.
Luc Schlangen, PhD contact
Niki Antypa, PhD principal investigator
Leiden University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bright Light Therapy and Blue Light Blocking Glasses in people with Depression, Unipolar and Depression, Bipolar, run by Universiteit Leiden at 2 sites in Netherlands.
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 17 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 9 Jan 2025. 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 Netherlands. 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?
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 Niki Antypa, PhD (+31 71 527 6677, nantypa@fsw.leidenuniv.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Improvement (time frame: 2-5 weeks). 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 NCT05958940, 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 9 Jan 2025.