Bright Light Therapy in the Morning or at Mid-Day in the Treatment of Non-Seasonal Bipolar Depressive Episodes (LuBi): Study Protocol for a Dose Research Phase I / II Trial
Open accessAbstract
Objective This study protocol aims to determine, using a rigorous approach in patients with bipolar disorder (BD) and non-seasonal major depressive episode (MDE), the characteristics of bright light therapy (BLT) administration (duration, escalation, morning and mid-day exposures) depending on the tolerance (hypomanic symptoms). Methods Patients with BD I or II and treated by a mood stabilizer are eligible. After 1 week of placebo, patients are randomized between either morning or mid-day exposure for 10 weeks of active BLT with glasses using a dose escalation at 7.5, 10, 15, 30 and 45 minutes/day. A further follow-up visit is planned 6 months after inclusion. Patients will be included by cohorts of 3, with at least 3 days of delay between them, and 1 week between cohorts. If none meet a dose limiting toxicity (DLT; i.e hypomanic symptoms), the initiation dose of the next cohort will be increased. If one patient meet a DLT, an additionnal cohort will start at the same dose. If 2 or 3 patients meet a DLT, from the same cohort or from two cohorts at the same dose initiation, the maximum tolerated dose is defined. This dose escalation will also take into account DLTs observed during the intra-subject escalation on previous cohorts, with a "Target Ceiling Dose" defined if 2 DLTs occured at a dose. Discussion Using an innovative and more ergonomic device in the form of glasses, this study aims to better codify the use of BLT in BD to ensure a good initiation and tolerance. Trial registrationaaClinicalTrials.gov Identifier: NCT03396744.
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Usage parameters for low-intensity BLT are not yet fully standardised.
“although usage parameters are not yet fully standardised (Geoffroy et al. 2018).”
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. 2018
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- Authors
- Geoffroy, P. A., Abbassi, E. M. B. E., Maruani, J., Etain, B., Lejoyeux, M., Amad, A., Courtet, P., Dubertret, C., Gorwood, P., Vaiva, G., Bellivier, F., & Chevret, S.
- Affiliations
- Inserm (FR)
- Assistance Publique – Hôpitaux de Paris (FR)
- Centre National de la Recherche Scientifique (FR)
- Corresponding author
- Geoffroy, Pierre Alexis
- ORCID
- Venue
- Psychiatry Investigation
- Publisher
- Korean Neuropsychiatric Association
- Published
- 2018-12-25
- Volume
- 15
- Issue
- 12
- Pages
- 1188-1202
- ISSN
- 1738-3684 (ISSN-L)
- 1976-3026
- PMC
- PMC6318493
- OpenAlex
- W2900814542
- Cited by
- 16
- References
- 56
- Citations by year
- 2026: 1 · 2025: 2 · 2024: 2 · 2021: 1 · 2020: 3 · 2019: 6 · 2018: 1
- FWCI
- 2.16
- Type
- journal article
- Language
- en
- Open access
- diamond
- doi.org
- Licence
- Locations
- Psychiatry Investigation (publishedVersion, cc-by-nc)
- Europe PMC (PubMed Central) (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- HAL (submittedVersion)
- Funders
- Assistance Publique Hôpitaux de Paris
- 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 disorder, dose escalation, maximum tolerated dose, dose-limiting toxicity, hypomanic symptoms, mood stabilizers
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