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      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

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          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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          Most cited references 43

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          The efficacy of light therapy in the treatment of mood disorders: a review and meta-analysis of the evidence.

          The purpose of this study was to assess the evidence base for the efficacy of light therapy in treating mood disorders. The authors systematically searched PubMed (January 1975 to July 2003) to identify randomized, controlled trials of light therapy for mood disorders that fulfilled predefined criteria. These articles were abstracted, and data were synthesized by disease and intervention category. Only 13% of the studies met the inclusion criteria. Meta-analyses revealed that a significant reduction in depression symptom severity was associated with bright light treatment (eight studies, having an effect size of 0.84 and 95% confidence interval [CI] of 0.60 to 1.08) and dawn simulation in seasonal affective disorder (five studies; effect size=0.73, 95% CI=0.37 to 1.08) and with bright light treatment in nonseasonal depression (three studies; effect size=0.53, 95% CI=0.18 to 0.89). Bright light as an adjunct to antidepressant pharmacotherapy for nonseasonal depression was not effective (five studies; effect size=-0.01, 95% CI=-0.36 to 0.34). Many reports of the efficacy of light therapy are not based on rigorous study designs. This analysis of randomized, controlled trials suggests that bright light treatment and dawn simulation for seasonal affective disorder and bright light for nonseasonal depression are efficacious, with effect sizes equivalent to those in most antidepressant pharmacotherapy trials. Adopting standard approaches to light therapy's specific issues (e.g., defining parameters of active versus placebo conditions) and incorporating rigorous designs (e.g., adequate group sizes, randomized assignment) are necessary to evaluate light therapy for mood disorders.
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            How might circadian rhythms control mood? Let me count the ways...

            Mood disorders are serious diseases that affect a large portion of the population. There have been many hypotheses put forth over the years to explain the development of major depression, bipolar disorder, and other mood disorders. These hypotheses include disruptions in monoamine transmission, hypothalamus-pituitary-adrenal axis function, immune function, neurogenesis, mitochondrial dysfunction, and neuropeptide signaling (to name a few). Nearly all people suffering from mood disorders have significant disruptions in circadian rhythms and the sleep/wake cycle. In fact, altered sleep patterns are one of the major diagnostic criteria for these disorders. Moreover, environmental disruptions to circadian rhythms, including shift work, travel across time zones, and irregular social schedules, tend to precipitate or exacerbate mood-related episodes. Recent studies have found that molecular clocks are found throughout the brain and body where they participate in the regulation of most physiological processes, including those thought to be involved in mood regulation. This review will summarize recent data that implicate the circadian system as a vital regulator of a variety of systems that are thought to play a role in the development of mood disorders. Copyright © 2013 Society of Biological Psychiatry. Published by Elsevier Inc. All rights reserved.
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              The World Federation of Societies of Biological Psychiatry (WFSBP) guidelines for the biological treatment of bipolar disorders: update 2012 on the long-term treatment of bipolar disorder.

              These guidelines are based on a first edition that was published in 2004, and have been edited and updated with the available scientific evidence up to October 2012. Their purpose is to supply a systematic overview of all scientific evidence pertaining to the long-term treatment of bipolar disorder in adults. Material used for these guidelines are based on a systematic literature search using various data bases. Their scientific rigor was categorised into six levels of evidence (A-F) and different grades of recommendation to ensure practicability were assigned. Maintenance trial designs are complex and changed fundamentally over time; thus, it is not possible to give an overall recommendation for long-term treatment. Different scenarios have to be examined separately: Prevention of mania, depression, or an episode of any polarity, both in acute responders and in patients treated de novo. Treatment might differ in Bipolar II patients or Rapid cyclers, as well as in special subpopulations. We identified several medications preventive against new manic episodes, whereas the current state of research into the prevention of new depressive episodes is less satisfactory. Lithium continues to be the substance with the broadest base of evidence across treatment scenarios. Although major advances have been made since the first edition of this guideline in 2004, there are still areas of uncertainty, especially the prevention of depressive episodes and optimal long-term treatment of Bipolar II patients.
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                Author and article information

                Journal
                Psychiatry Investig
                Psychiatry Investig
                PI
                Psychiatry Investigation
                Korean Neuropsychiatric Association
                1738-3684
                1976-3026
                December 2018
                26 November 2018
                : 15
                : 12
                : 1188-1202
                Affiliations
                [1 ]Inserm, U1144, Paris, F-75006, France
                [2 ]Université Paris Diderot, Sorbonne Paris Cité, UMR-S 1144, Paris, F-75013, France
                [3 ]AP-HP, GH Saint-Louis – Lariboisière – F. Widal, Département de Psychiatrie et de Médecine Addictologique, 75475 Paris cedex 10, France
                [4 ]Fondation FondaMental, Créteil, 94000, France
                [5 ]AP-HP, GH Saint-Louis – Lariboisière – F. Widal, service de biostatistique et information médicale, Paris, France
                [6 ]Department of Epidemiology, Paris Hospital Group - Psychiatry & Neurosciences, 1 rue Cabanis, 75014 Paris, France
                [7 ]Department of Psychiatry and Addictive Medicine, Assistance Publique-Hôpitaux de Paris (AP-HP), Paris, France
                [8 ]University Hospital Bichat-Claude Bernard, 46 rue Henri Huchard, 75018 Paris, France
                [9 ]Paris Diderot University - Paris VII, 5 Rue Thomas Mann, 75013 Paris, France
                [10 ]Univ. Lille, CNRS UMR 9193-PsyCHIC-SCALab, Lille, France
                [11 ]CHU Lille, Department of Psychiatry, F-59000 Lille, France
                [12 ]Department of Emergency Psychiatry & Acute Care, CHU Montpellier, Inserm Unit 1061, University of Montpellier, Montpellier, France
                [13 ]AP-HP, Department of Psychiatry, Louis-Mourier Hospital, Colombes, France
                [14 ]University Paris 7 Denis Diderot, Faculty of Medicine, Paris, France
                [15 ]INSERM U894, Centre for Psychiatry and Neurosciences, 2 ter rue d’Alesia, 75014, Paris, France
                [16 ]Université Paris Descartes, Sorbonne Paris Cité, Paris, France
                [17 ]Hopital Sainte-Anne (CMME), Paris, France
                [18 ]ECSTRA Team, UMR1153, Inserm, Paris Diderot University, Paris, France
                Author notes
                Correspondence: Pierre Alexis Geoffroy, MD, PhD AP-HP, GH Saint-Louis–Lariboisière–F. Widal, Département de Psychiatrie et de Médecine Addictologique, 200 rue du faubourg saint denis, 75475 Paris cedex 10, France Tel: +33 1 40 05 48 81, Fax: +33 1 40 05 49 33, E-mail: pierre.a.geoffroy@ 123456gmail.com
                Article
                pi-2018-09-27-1
                10.30773/pi.2018.09.27.1
                6318493
                30466205
                bbeae675-df76-4d9d-94a5-ed729d339c57
                Copyright © 2018 Korean Neuropsychiatric Association

                This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

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