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NCT07462637

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

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

173

Start Date

2026-03-01

Completion Date

2029-05-01

Last Updated

2026-03-10

Healthy Volunteers

Yes

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.

Patients : Inclusion Criteria: 1. Adults between 18 and 65 years old 2. Patients with a diagnosis of MDE as part of a unipolar or bipolar disorder (DSM-5 TR criteria) 3. Patients with a clinician-rated MADRS score ≥ 20 indicating a moderate to severe depressive symptoms with a prescription of LT for MDE treatment 4. For patients with bipolar disorder type 1: With prophylactic mood stabilizer treatment at an effective dose (standardized and at a preventive dose for manic episode prevention) and stable for at least 4 weeks (background treatment for bipolar disorder): Lithium (Téralithe® LP 400 or 250) or Sodium Valproate (Dépakote® 500) or Atypical antipsychotics (also known as second-generation antipsychotics), defined as follows and dosed prior to inclusion in the month preceding: * For Lithium, controlled by serum lithium level, \>0.5 mEq/L for Téralithe 250 and \> 0.7 mEq/L for Téralithe LP 400 ; for Sodium Valproate, controlled by serum sodium divalproate level \>40mg/L * For antipsychotics, only the following molecules will be accepted at the indicated dosages, as they have marketing authorization in France as prophylactic mood stabilizers for manic episode prevention in bipolar disorder: Quétiapine (≥150-800mg), Aripiprazole (≥ 15-30mg), Olanzapine (≥ 10-20mg) 5. Patients for whom light therapy is prescribed 6. Patients able to understand French. 7. Patients able to sign informed consent. Exclusion Criteria: 1. Patients with a DSM-5 diagnosis of schizophrenia, suffering from paranoid or delusional disorders, any other psychotic features or other nonstabilized mental disorders 2. Patients with other antidepressant strategies than LT or mood stabiliser initiated in the month prior to inclusion 3. Patients with a therapeutic resistance of current MDE (lack of response to ≥2 antidepressants of 2 different classes at therapeutic doses for \>6 weeks) 4. Patients with a LT used in the last 1 month 5. Patient with ophtalmic pathologies (cataract, glaucoma, age-related macular degeneration, severe myopia \> 6D, etc.) or diseases affecting the retina (retinitis pigmentosa, diabetes, herpes, hereditary retinal disorders etc.). 6. Patient with photosensitive epilepsy 7. Patients with a C-SSRS score ≥ 4 8. For the MRI group, patient presenting one or several MRI contrindications 9. Shiftwork or self-imposed irregular sleep schedule within the last months 10. Travel acrosss 2 time-zones during the last month prior to participation 11. Pregnant or breastfeeding women 12. Subject under guardianship or deprived of liberty 13. Participation ton another interventional study Healthy volonteers : Inclusion criteria : 1. Adults between 18 and 65 2. Without any significant psychiatric history or current psychotropic medication 3. Able to understand French 4. Able to sign informed consent Exclusion criteria : 1. Contra-indications to MRI (claustrophobia, metallic or material implants) 2. History of severe head injury 3. Pregnancy and breastfeeding woman 4. Inability to understand information about the study 5. Persons deprived of their liberty by judicial or administrative decision 6. Adult subject under legal protection or unable to consent

Locations (1)

Bichat - Claude-Bernard Hospital

Paris, France