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Clinical trial Recruiting at 1 site Interventional Ages 18 to 65

Light therapy response in unipolar and bipolar major depressive episodes

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

Run by Assistance Publique - Hôpitaux de Paris · NCT07462637 · Data updated 2026-11-12

This study tests whether light therapy helps adults with a major depressive episode respond to treatment, including those with unipolar or bipolar depression.

Quick facts

Study typeInterventional
Ages18 Years to 65 Years
SexAll
Enrollment173 (estimated)
SponsorAssistance Publique - Hôpitaux de Paris
Academic / other
Locations1 site (Paris)
StatusRecruiting
StartedJune 17, 2026
Main results expectedAugust 2029
Study endsAugust 2029
Registry record updatedAugust 12, 2026
Trial IDNCT07462637 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults 18–65 with a DSM-5-TR diagnosis of a major depressive episode (unipolar or bipolar) and a MADRS score ≥ 20, already prescribed light therapy for MDE treatment.

Probably not a fit

Patients with non-depressive psychiatric disorders, mild symptoms (MADRS < 20), or contraindications to light therapy may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study explores the use of light therapy as a treatment for major depressive episodes in adults aged 18 to 65, including unipolar and bipolar conditions with or without seasonal patterns. Participants must have moderate to severe depressive symptoms (MADRS ≥ 20) and be on a stable light therapy prescription for MDE treatment. The study aims to identify responsive patients and downstream biomarkers related to light exposure, and to characterize how lighting parameters relate to outcomes. Light therapy is evaluated for its potential to improve mood, sleep, and circadian regulation compared with baseline treatments. The research builds on prior evidence suggesting light therapy can be as effective as antidepressants for MDE and may offer circadian and daytime alertness benefits.

Why it matters

Potential benefit: If successful, patients could experience improved mood and functioning with a non-pharmacologic option that also supports sleep and circadian health.

How similar studies have gone: Previous meta-analyses suggest light therapy can be as effective as antidepressants for MDE, supporting potential benefit in this context.

Who can join: the full rules

Show full inclusion / exclusion criteria 
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

Where it's running

  • Bichat - Claude-Bernard Hospital
    Paris, France     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.