Psychiatry Investig.
2018 Dec;15(12):1188-1202. 10.30773/pi.2018.09.27.1.
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
- Affiliations
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- 1Inserm, U1144, Paris, F-75006, France. pierre.a.geoffroy@gmail.com
- 2Université Paris Diderot, Sorbonne Paris Cité, UMR-S 1144, Paris, F-75013, France.
- 3AP-HP, GH Saint-Louis – Lariboisière – F. Widal, Département de Psychiatrie et de Médecine Addictologique, 75475 Paris cedex 10, France.
- 4Fondation FondaMental, Créteil, 94000, France.
- 5AP-HP, GH Saint-Louis – Lariboisière – F. Widal, service de biostatistique et information médicale, Paris, France.
- 6Department of Epidemiology, Paris Hospital Group - Psychiatry & Neurosciences, 1 rue Cabanis, 75014 Paris, France.
- 7Department of Psychiatry and Addictive Medicine, Assistance Publique-Hôpitaux de Paris (AP-HP), Paris, France.
- 8University Hospital Bichat-Claude Bernard, 46 rue Henri Huchard, 75018 Paris, France.
- 9Paris Diderot University - Paris VII, 5 Rue Thomas Mann, 75013 Paris, France.
- 10Univ. Lille, CNRS UMR 9193-PsyCHIC-SCALab, Lille, France.
- 11CHU Lille, Department of Psychiatry, F-59000 Lille, France.
- 12Department of Emergency Psychiatry & Acute Care, CHU Montpellier, Inserm Unit 1061, University of Montpellier, Montpellier, France.
- 13AP-HP, Department of Psychiatry, Louis-Mourier Hospital, Colombes, France.
- 14University Paris 7 Denis Diderot, Faculty of Medicine, Paris, France.
- 15INSERM U894, Centre for Psychiatry and Neurosciences, 2 ter rue d’Alesia, 75014, Paris, France.
- 16Université Paris Descartes, Sorbonne Paris Cité, Paris, France.
- 17Hopital Sainte-Anne (CMME), Paris, France.
- 18ECSTRA Team, UMR1153, Inserm, Paris Diderot University, Paris, France.
- KMID: 2434769
- DOI: http://doi.org/10.30773/pi.2018.09.27.1
Abstract
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 REGISTRATION: ClinicalTrials.gov Identifier: NCT03396744.
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