BioClock: Bright Light Therapy for Depressive Disorders

Depression, Unipolar Clinical Trial

Official title: BioClock: Optimization, Working Mechanisms and Response Predictors of Bright Light Therapy for Depressive Disorders - a Multicentre Randomized Controlled Trial

Status Not yet recruiting

Clinical 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 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Depression, Bipolar
• Depression, Unipolar
• Depressive Disorder

• NCT number: NCT05958940
• Study type: Interventional
• Source: Universiteit Leiden
• Contact: Niki Antypa, PhD
• Phone: +31 71 527 6677
• Email: nantypa@fsw.leidenuniv.nl
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2023
• Completion date: December 2025