Bright Light Therapy for Depression
BioClock: Optimization, Working Mechanisms and Response Predictors of Bright Light Therapy for Depressive Disorders - a Multicentre Randomized Controlled Trial
This study tests if Bright Light Therapy can help people with unipolar and bipolar depression feel better, and whether adding lifestyle changes can make it work even better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 231 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Universiteit Leiden Academic / other |
| Locations | 2 sites (Eindhoven and 1 other locations) |
| Trial ID | NCT05958940 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of Bright Light Therapy (BLT) for individuals suffering from unipolar and bipolar depression. The study aims to optimize the administration of BLT, understand its treatment mechanisms, and identify patient characteristics that predict positive responses. Additionally, it explores whether lifestyle interventions can enhance the effects of BLT and how it impacts sleep quality and the body's internal clock. Participants will be assessed for their eligibility based on specific criteria related to their depressive episodes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 65 diagnosed with unipolar or bipolar depression experiencing a current depressive episode.
Not a fit: Patients currently experiencing a (hypo)manic or mixed episode, or those with prominent active suicidality may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective and personalized treatment option for patients with depressive disorders.
How similar studies have performed: Previous studies have shown that Bright Light Therapy is effective for treating depression, indicating that this approach has a foundation of success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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
Where this trial is running
Eindhoven and 1 other locations
- GGzE - Mental Health Institute of Eindhoven and the Kempen — Eindhoven, Netherlands (Recruiting)
- Leids Universitair Behandel- en Expertise Centrum — Leiden, Netherlands (Recruiting)
Study contacts
- Principal investigator: Niki Antypa, PhD — Leiden University
- Study coordinator: Niki Antypa, PhD
- Email: nantypa@fsw.leidenuniv.nl
- Phone: +31 71 527 6677
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.