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BioClock: Bright Light Therapy for Depressive Disorders

RecruitingNAAges 18 Years - 65 YearsAllUniversiteit Leiden
NCT05958940 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 thes

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📋 Eligibility rules (as published)
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
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What it tests

  • Bright Light Therapy
  • Blue Light Blocking Glasses
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Where

2 sites
GGzE - Mental Health Institute of Eindhoven and the Kempen
Eindhoven, Netherlands
Leids Universitair Behandel- en Expertise Centrum
Leiden, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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