Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT05958940

BioClock: Bright Light Therapy for Depressive Disorders

Led by Universiteit Leiden · Updated on 2025-01-09

231

Participants Needed

2

Research Sites

146 weeks

Total Duration

On this page

Sponsors

U

Universiteit Leiden

Lead Sponsor

E

Eindhoven University of Technology

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

BioClock: Bright Light Therapy for Depressive Disorders

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 65.
  • Diagnosis of unipolar or bipolar depression (seasonal or non-seasonal) confirmed by Mini-International Neuropsychiatric Interview (M.I.N.I.).
  • Current depressive episode with a score of 6 or higher on the Quick Inventory of depressive symptomatology Self Report (QIDS-SR).
  • Sufficient knowledge of Dutch or English to complete questionnaires.
  • Provided informed consent.
Not Eligible

You will not qualify if you...

  • Current (hypo)manic or mixed episode as assessed with M.I.N.I.
  • Current psychotic episode as assessed with M.I.N.I.
  • Active suicidality with score of 10 or higher on the M.I.N.I. module.
  • Started antidepressant therapy or specific depression treatments less than 2 months before study entry.
  • Bipolar disorder patients not on mood-stabilizing treatment for at least 1 month at recommended dosage.
  • Use of melatonin or agomelatine in the last month.
  • Current use of antibiotics.
  • Current use of medication increasing light sensitivity.
  • Travel across more than 1 time zone in the past month or during treatment.
  • Recent sunny holidays or winter sports in the past month.
  • Pre-existing eye or skin disorders such as retinitis pigmentosa, porphyria, chronic actinic dermatitis, or sun-induced urticaria.
  • Systemic disorders with potential retinal involvement like rheumatoid arthritis or systemic lupus erythematosus.
  • Colour blindness.
  • Night shift work in the last three months.
  • Retinal blindness, severe cataract, or glaucoma.
  • Light-induced migraine or epilepsy.
  • Pregnancy or parenting a child younger than 18 months.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 2 locations

1

GGzE - Mental Health Institute of Eindhoven and the Kempen

Eindhoven, Netherlands, 5626 ND

Actively Recruiting

2

Leids Universitair Behandel- en Expertise Centrum

Leiden, Netherlands, 5626 ND

Actively Recruiting

Loading map...

Research Team

N

Niki Antypa, PhD

CONTACT

L

Luc Schlangen, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

BioClock: Bright Light Therapy for Depressive Disorders | DecenTrialz