Signature Response to Light Therapy in Unipolar and Bipolar Major Depressive Episode (MDE)

Summary

Major depressive episode (MDE) are severe and common psychiatric disorders that affect up to 20% of the general population. MDE cause a decrease in psychosocial functioning, quality of life, and is associated with a high rate of suicides. They will be the leading cause of disability by 2030 according to the World Health Organization. The international effort carried out to identify biomarkers of MDE has been hampered by the heterogenous nature of MDE (unipolar, bipolar, seasonal, non-seasonal) and their heterogeneous response to treatment. Response rate to antidepressant drugs is only 40 to 50%, leading to the use of drug combinations and development of alternative therapeutics such as light therapy (LT). It was demonstrated that LT, as a first line treatment of MDE with and without seasonal pattern (± SP), has comparable efficacy to antidepressants. LT has the advantage of being also effective in improving both sleep, alertness and circadian rhythms, which may be altered in depression, contrary to antidepressant drugs that target mainly mood. Further research is warranted to determine the most efficient lighting parameters to use depending on depression characteristics, as well as to identify signature biomarkers of response. Besides, no studies have directly evaluated both subjective and objective biomarkers of sleep, wake, biological rhythms, and light signalling pathways and activation in patients with MDE ± SP. The main objective of the research will be to identify the signature of response to LT examining the correlation between the measures of biological and clinical parameters before LT and their evolution at the end of the procedure, and the therapeutic response.

The primary endpoint of the study will be the therapeutic response to LT measured by the difference of MADRS score between Visit 1 and Visit 4 (end of the therapeutic protocol). Therapeutic response to LT considered as a success will be defined as at least a 50% reduction of MADRS score between the two visits.

Conditions

• Major Depressive Episode

Interventions

DEVICE

Light therapy

It consists of daily exposure to 10 000-lux fluorescent white light box (French light box, Dayvia®, Slim style device) for 30 minutes. Patients with a diagnosis of major depressive episode (MDE) will be treated for 4 weeks by light therapy in the morning after awakening, preferably between 7 and 9 am. Patients with bipolar depression and medicated will need to be pre-treated with a mood stabiliser antimanic agent to limit the risk of manic switch. In case of treatment-emergent hypomanic symptoms assessed with the YMRS for all patients, the exposition to LT will be reduced to 15 min or stopped if the patient is already at 15 min. In case of LT cessation for hypomanic switch, the patient will be considered as responder.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris

  lead OTHER

Principal Investigators

• Pierre-Alexis GEOFFROY, Pr · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation

NA

Purpose

BASIC_SCIENCE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-06-17

Primary Completion

2029-08-31

Completion

2029-08-31

Countries

• France

Study Locations