Bright Light Therapy in the Morning or Midday for the Treatment of Nonseasonal Depression in Bipolar Disorder (LuBi): A Dose-Escalation Phase 1/2 Randomized Double-Blind Trial
Abstract
Objective: This dose-escalation study aimed to evaluate the tolerance (hypomanic symptoms) and efficacy of bright light therapy (BLT) in depressed patients with bipolar disorder (BD) with mood stabilizers, using different schedules (duration and escalation), applied in morning or midday. Methods: Patients with BD I or II ( DSM-IV TR ) followed a 1-week placebo phase and were randomized to morning or midday BLT with dose escalation from 7.5 to 45 minutes/d, until September 2023. Inter- and intrasubject escalation were performed, with dose adjustments based on dose-limiting toxicities (DLTs) to determine the maximum tolerated dose (MTD) and target ceiling dose (TCD) of BLT exposure. The primary outcome measure, DLT, was assessed weekly after each dose initiation or increase and defined as a hypomanic switch (Young Mania Rating Scale [YMRS] score ≥12/60) or subsyndromic hypomanic symptoms (YMRS score 8-12). Results: Both groups reached the starting dose of 45 minutes without reaching the MTD or TCD, enrolling 38 patients (morning = 18 and midday = 16) and demonstrating good tolerance and acceptability. Two patients (6%) experienced a hypomanic switch at 45 minutes: 1 in the morning group (week 1) and 1 in the midday group (week 4). Five patients had subsyndromic hypomania. All symptoms improved within 3 days after dose reduction. Depressive symptoms (Montgomery Asberg Depression Rating Scale, P = .007) and Clinical Global Impression (CGI) scores ( P P = .01 for improvement) sign…
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In the LuBi trial, 2 out of 34 participants (6%) experienced a hypomanic switch.
“Of note, in the LuBi trial (Geoffroy et al. 2025), the only one recent randomised controlled trial that has specifically examined hypomanic switch rates in a dose-escalation design, 2 out of 34 participants (6%) experienced a hypomanic switch.”
From Light therapy for bipolar disorders: Clinical recommendations from the international society for bipolar disorders (ISBD) Chronobiology and Chronotherapy Task Force (2025) · cites this paper as Geoffroy et al. 2025
Hypomanic symptoms that appear during bright light therapy can resolve with a simple decrease in dosage (duration and/or intensity) or by stopping bright light therapy if it is not enough to quickly reduce (hypo)manic symptoms.
“Hypomanic symptoms that appear during BLT can resolve with a simple decrease in dosage (duration and/or intensity) or by stopping BLT if it is not enough to quickly reduce (hypo)manic symptoms (Sit et al. 2007; Lam et al. 2020; Geoffroy et al. 2025).”
From Light therapy for bipolar disorders: Clinical recommendations from the international society for bipolar disorders (ISBD) Chronobiology and Chronotherapy Task Force (2025) · cites this paper as Geoffroy et al. 2025
Suicidal ideation and manic switch are infrequent adverse effects of light therapy.
“Suicidal ideation and manic switch are infrequent adverse effects of light therapy (Sit and Haigh 2019; Lam et al. 2021; Geoffroy et al. 2025).”
From Light therapy for bipolar disorders: Clinical recommendations from the international society for bipolar disorders (ISBD) Chronobiology and Chronotherapy Task Force (2025) · cites this paper as Geoffroy et al. 2025
In the case of Bright Light Therapy there are now at least eight randomised controlled trials suggesting its efficacy, safety, and tolerability in the treatment of bipolar depression.
“in the case of Bright Light Therapy there are now at least eight randomised controlled trials (RCTs) suggesting its efficacy, safety, and tolerability in the treatment of bipolar depression [26, 27]”
From Essential Information About Chronobiology and Chronotherapy for the Optimal Care of People With Bipolar Disorders: An Expert Consensus (2026) · cites this paper as [27]
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Geoffroy, P. A., Palagini, L., Henriksen, T. E. G., Bourgin, P., Garbazza, C., Gronfier, C., Esaki, Y., Fernandez, D. C., Lam, R. W., Lee, H.-J., et al. (2025) · Dialogues in Clinical Neuroscience · doi:10.1080/19585969.2025.2533806 · Cited by 10 · see citing works
Self-citationCrouse, J. J., Loblay, V., Jorm, A., Wong, T. R., de Haan, Z., Gorban, C., Shin, M., Tonini, E., Aiken, C., Alloy, L. B., et al. (2026) · Bipolar Disorders · doi:10.1111/bdi.70141 · Cited by 3 · see citing works
Self-citation
- Authors
- Geoffroy, P. A., Chevret, S., Mauries, S., Chaffaut, C., Amad, A., Bellivier, F., Benard, V., Courtet, P., Dubertret, C., Gorwood, P., Mazer, N., Mekaoui, L., Olié, E., Pataud, G., Vaiva, G., Lejoyeux, M., Sit, D., & Maruani, J.
- Affiliations
- Centre National de la Recherche Scientifique (FR)
- Inserm (FR)
- Northwestern University (US)
- ORCID
- Venue
- The Journal of Clinical Psychiatry
- Publisher
- Physicians Postgraduate Press, Inc
- Published
- 2025-06-23
- Volume
- 86
- Issue
- 3
- Pages
- 25m15826
- ISSN
- 0160-6689 (ISSN-L)
- 1555-2101
- OpenAlex
- W4411566062
- Cited by
- 7
- References
- 0
- Citations by year
- 2026: 6 · 2025: 1
- FWCI
- 4.73
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The Journal of Clinical Psychiatry (publishedVersion)
- PubMed (publishedVersion)
- HAL (submittedVersion)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Bipolar Disorder and Treatment
- Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
- Life Sciences › Neuroscience › Endocrine and Autonomic Systems › Circadian rhythm and melatonin
- Keywords
- bright light therapy, bipolar depression, bipolar disorder, dose escalation, maximum tolerated dose, hypomanic symptoms, mood stabilizers, antidepressant treatment
- MeSH terms
- Adult, Bipolar Disorder, Double-Blind Method, Female, Humans, Male, Middle Aged, Phototherapy, Time Factors, Treatment Outcome, Maximum Tolerated Dose
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