Contenuto dell'articolo principale
Abstract
Introduzione: I disturbi depressivi rappresentano un importante problema di salute pubblica in considerazione della prevalenza, degli elevati tassi di disabilití e di mortalití ad esso associati. Studi recenti suggeriscono che l'uso combinato di differenti interventi di cronoterapia possa rivelarsi efficace nel rapido miglioramento della sintomatologia depressiva.
Obiettivo: Questo articolo descrive il protocollo di uno studio che si pone l'obiettivo di stabilire l'efficacia di un intervento di tripla cronoterapia (trattamento combinato di privazione totale di sonno, luce terapia e allungamento di fase di sonno) nel miglioramento della sintomatologia depressiva di persone affette da depressione unipolare o bipolare.
Metodi: Verrí condotto un trial clinico randomizzato controllato con arruolamento di pazienti affetti da depressione unipolare o bipolare, ricoverati presso il Servizio Psichiatrico di Diagnosi e Cura dell'Ospedale San Paolo – ASST Santi Paolo e Carlo di Milano. I soggetti saranno assegnati in modo randomizzato all'intervento (Triple Chronotherapy in aggiunta al trattamento farmacologico standard) o al gruppo "controllo" (trattamento farmacologico standard).
Risultati: L'arruolamento, iniziato a dicembre 2018, con previsione di termine ad ottobre 2020, o prima in caso di raggiungimento del campione previsto. Il protocollo di studio ha gií ricevuto l'approvazione da parte del comitato etico aziendale ed è stato registrato su EudraCT con N° 2019-000892-18. Le analisi che ne deriveranno mirano a verificare se la tripla cronoterapia produca un rapido e stabile miglioramento della sintomatologia depressiva in persone ricoverate per un episodio depressivo unipolare o bipolare.
Parole chiave: Depressione, Cronoterapia, Avanzamento di Fase del Sonno, Luce Terapia, Deprivazione di Sonno
Triple Chronotherapy approach for reducing depressive symptoms and suicidal intent in hospitalized patients: Study protocol of a Randomized Controlled Trial
Background: Depressive disorders are a relevant burden for public health due to their prevalence and high levels of associated disability and mortality. Recent studies suggest that the combination of multiple chronotherapuetic interventions may reveal effective in the rapid improvement of depressive symptoms.
Objective: This paper describes the protocol of a study that aims to test the efficacy of a triple chronotherapy intervention (combined total sleep deprivation, light therapy and sleep phase advance) in the improvement of depressive symptoms in individuals diagnosed with unipolar or bipolar depression.
Methods: A randomized controlled trial will be conducted in patients hospitalized with a unipolar or bipolar depression at the Servizio Psichiatrico di Diagnosi e Cura inpatient unit of the San Paolo – ASST Santi Paolo e Carlo Hospital in Milan, Italy. Individuals will be randomly assigned to the intervention (triple chronotherapy add–on to standard pharmacological treatment) or to the "control" group (standard pharmacological treatment).
Results: Enrolment began in December 2018 and will end in October 2020, or at any earlier point in which the expected sample size will be reached. The study protocol has already been approved by the local ethics committee and is registered as EudraCT 2019-000892-18. Outcome analyses aim to verify whether triple chronotherapy produces a rapid and stable improvement in depressive symptoms in individuals hospitalized for an acute unipolar or bipolar depressive episode.
Keywords: Depression, Chronotherapeutic, Sleep–Phase Advance, Bright Light Therapy, Sleep Deprivation
Dettagli dell'articolo
Riferimenti
- Al-Karawi, D., & Jubair L. (2016) Bright light therapy for nonseasonal depression: Meta-analysis of clinical trials. Journal of Affective Disorders, (1), 64–71
- American Psychological Association (APA) (2010) Practice Guideline for the Treatment of Patients with Major Depressive Disorder. Data di accesso 14/09/2016 da
- Benca, R.M., Obermeyer, W.H., Thisted, R.A., & Gillin, J.C. (1992) Sleep and psychiatric disorders. A metaanalysis. Arch. Gen. Psychiatry, 49(8), 651–668; discussion 669–670.
- Benedetti, F., Barbini, B., Colombo, C., & Smeraldi, E. (2007) Chronotherapeutics in a psychiatric ward. Sleep Medicine Reviews, 11, 509–522.
- Cohen, J. (1992) A power primer. Psychol Bull, 112(1),155-159.
- Connolly, K.R., & Thase, M.E. (2011) If at first you don't succeed: a review of the evidence for antidepressant augmentation, combination and switching strategies. Drugs, 71(1), 43–64.
- Echizenya, M., Suda, H., Takeshima, M., Inomata, Y., & Shimizu, T. (2013) Total sleep deprivation followed by sleep phase advance and bright light therapy in drug-resistant mood disorders. J Affect Disord 2013, 144(1-2),28-33.
- Fava, M. (2003) Diagnosis and definition of treatment-resistant depression. Biol Psychiatry, 53(8),649–659.
- Lopez, A.D., & Murray, C.J. (1996) The Global Burden of Disease: A Comprehensive Assessment of Mortality and Disability from Diseases, Injuries, and Risk Factors in 1990 and Projected to 2020. Harvard School of Public Health.
- Lopez-Rodriguez, F., Wilson, C.L., Maidment, N.T., Poland, R.E., & Engel, J. (2003) Total sleep deprivation increases extracellular serotonin in the rat hippocampus. Neuroscience, 121(2), 523-530.
- Martiny, K., Refsgaard, E., Lund, V., Lunde, M., Sorensen, L., Thougaard, B., Lindberg, L., & Bech P. (2012) A 9-week randomized trial. comparing a chronotherapeutic intervention (wake and light therapy) to exercise in major depressive disorder patients treated with duloxetine. J Clin psychiatry, 73(9), 1234-1242.
- Papakostas, G.I., & Fava, M. (2009) Does the probability of receiving placebo influence clinical trial outcome? A meta-regression of double-blind, randomized clinical trials in MDD. European Neuropsychopharmacology, 19(1), 34–40.
- Pillai, V., Kalmbach, D.A., & Ciesla, J.A. (2011) A meta-analysis of electroencephalographic sleep in depression: evidence for genetic biomarkers. Biol. Psychiatry, 70(10), 912–9.
- Rosenthal, N.E., Sack, D.A., Gillin, J.C., Lewy, A.J., Goodwin, F.K., Davenport, Y., Mueller,P.S., Newsome D.A., & Wehr, T.A. (1984) Seasonal affective disorder. A description of the syndrome and preliminary findings with light therapy. Arch Gen Psychiatry,41(1), 72–80.
- Shirani, A., & St. Louis, E.K. (2009) Illuminating Rationale and Uses for Light Therapy. J Clin Sleep Med, 5(2), 155–63.
- Tuunainen, A., Kripke, D.F., & Endo, T. (2004) Light therapy for non-seasonal depression. Cochrane Database Syst Rev,2: CD004050.
- Wirz-Justice, A., Benedetti, F., & Terman, M. (2009) Chronotherapeutics for affective disorders. Karger, Basel. Data accesso 01/09/2015 da https://www.karger.com/Book/Toc/
- World Health Organization (OMS) (2015) Depression Fact Sheet. Data accesso 25/10/2016 da http://www. who.int/mediacentre/factsheets/fs369/en/.
- Wu, J.C., Kelsoe, J.R., Schachat, C., Bunney, B.G., DeModena, A., Golshan, S., Gillin, J.C., Potkin, S.G., & Bunney, W.E. (2009) Rapid and sustained antidepressant response with sleep deprivation and chronotherapy in bipolar disorder. Biol Psychiatry, 66(3),298-301.
- Wu, J.C., Buchsbaum, M., & Bunney jr, W.E. (2001) Clinical neurochemical implications of sleep deprivation's effects on the anterior cingulated of depressed responders. Neuropsychopharmacology, 25 (5), 74-78.
- Wu, J.C., & Bunney, W.E. (1990) The biological basis of an antidepressant response to sleep deprivation and relapse: review and hypothesis. American Journal of Psychiatry, 147(1), 14–21.
Riferimenti
Al-Karawi, D., & Jubair L. (2016) Bright light therapy for nonseasonal depression: Meta-analysis of clinical trials. Journal of Affective Disorders, (1), 64–71
American Psychological Association (APA) (2010) Practice Guideline for the Treatment of Patients with Major Depressive Disorder. Data di accesso 14/09/2016 da
Benca, R.M., Obermeyer, W.H., Thisted, R.A., & Gillin, J.C. (1992) Sleep and psychiatric disorders. A metaanalysis. Arch. Gen. Psychiatry, 49(8), 651–668; discussion 669–670.
Benedetti, F., Barbini, B., Colombo, C., & Smeraldi, E. (2007) Chronotherapeutics in a psychiatric ward. Sleep Medicine Reviews, 11, 509–522.
Cohen, J. (1992) A power primer. Psychol Bull, 112(1),155-159.
Connolly, K.R., & Thase, M.E. (2011) If at first you don't succeed: a review of the evidence for antidepressant augmentation, combination and switching strategies. Drugs, 71(1), 43–64.
Echizenya, M., Suda, H., Takeshima, M., Inomata, Y., & Shimizu, T. (2013) Total sleep deprivation followed by sleep phase advance and bright light therapy in drug-resistant mood disorders. J Affect Disord 2013, 144(1-2),28-33.
Fava, M. (2003) Diagnosis and definition of treatment-resistant depression. Biol Psychiatry, 53(8),649–659.
Lopez, A.D., & Murray, C.J. (1996) The Global Burden of Disease: A Comprehensive Assessment of Mortality and Disability from Diseases, Injuries, and Risk Factors in 1990 and Projected to 2020. Harvard School of Public Health.
Lopez-Rodriguez, F., Wilson, C.L., Maidment, N.T., Poland, R.E., & Engel, J. (2003) Total sleep deprivation increases extracellular serotonin in the rat hippocampus. Neuroscience, 121(2), 523-530.
Martiny, K., Refsgaard, E., Lund, V., Lunde, M., Sorensen, L., Thougaard, B., Lindberg, L., & Bech P. (2012) A 9-week randomized trial. comparing a chronotherapeutic intervention (wake and light therapy) to exercise in major depressive disorder patients treated with duloxetine. J Clin psychiatry, 73(9), 1234-1242.
Papakostas, G.I., & Fava, M. (2009) Does the probability of receiving placebo influence clinical trial outcome? A meta-regression of double-blind, randomized clinical trials in MDD. European Neuropsychopharmacology, 19(1), 34–40.
Pillai, V., Kalmbach, D.A., & Ciesla, J.A. (2011) A meta-analysis of electroencephalographic sleep in depression: evidence for genetic biomarkers. Biol. Psychiatry, 70(10), 912–9.
Rosenthal, N.E., Sack, D.A., Gillin, J.C., Lewy, A.J., Goodwin, F.K., Davenport, Y., Mueller,P.S., Newsome D.A., & Wehr, T.A. (1984) Seasonal affective disorder. A description of the syndrome and preliminary findings with light therapy. Arch Gen Psychiatry,41(1), 72–80.
Shirani, A., & St. Louis, E.K. (2009) Illuminating Rationale and Uses for Light Therapy. J Clin Sleep Med, 5(2), 155–63.
Tuunainen, A., Kripke, D.F., & Endo, T. (2004) Light therapy for non-seasonal depression. Cochrane Database Syst Rev,2: CD004050.
Wirz-Justice, A., Benedetti, F., & Terman, M. (2009) Chronotherapeutics for affective disorders. Karger, Basel. Data accesso 01/09/2015 da https://www.karger.com/Book/Toc/
World Health Organization (OMS) (2015) Depression Fact Sheet. Data accesso 25/10/2016 da http://www. who.int/mediacentre/factsheets/fs369/en/.
Wu, J.C., Kelsoe, J.R., Schachat, C., Bunney, B.G., DeModena, A., Golshan, S., Gillin, J.C., Potkin, S.G., & Bunney, W.E. (2009) Rapid and sustained antidepressant response with sleep deprivation and chronotherapy in bipolar disorder. Biol Psychiatry, 66(3),298-301.
Wu, J.C., Buchsbaum, M., & Bunney jr, W.E. (2001) Clinical neurochemical implications of sleep deprivation's effects on the anterior cingulated of depressed responders. Neuropsychopharmacology, 25 (5), 74-78.
Wu, J.C., & Bunney, W.E. (1990) The biological basis of an antidepressant response to sleep deprivation and relapse: review and hypothesis. American Journal of Psychiatry, 147(1), 14–21.