Very Low-Level Transcranial Photobiomodulation for Major Depressive Disorder: The ELATED-3 Multicenter, Randomized, Sham-Controlled Trial
Iosifescu DV, Norton RJ, Tural U, Mischoulon D, Collins K, McDonald E, De Taboada L, Foster S, Cusin C, Yeung A, Clain A, Schoenfeld D, Hamblin MR, Cassano P
The Journal of clinical psychiatry · 21 citas
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Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación no declarada
Publicación
- Publicado
- 2022-08-04 · J Clin Psychiatry · vol. 83 · número 5
- Editorial
- Physicians Postgraduate Press, Inc.
- Citado
- 39 citas · más que el 95% de estudios similares · 4.1× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 0 trabajos
- Acceso
- De pago
- Áreas de investigación
- Laser Applications in Dentistry and Medicine · Transcranial Magnetic Stimulation Studies · Treatment of Major Depression
- Palabras clave
- transcranial photobiomodulation, major depressive disorder, near-infrared light, prefrontal cortex stimulation, treatment efficacy, adjunctive therapy, Hamilton Depression Rating Scale, treatment-resistant depression
- MeSH
- prefrontal cortex, humans, treatment outcome, double-blind method, euphoria, adult, middle aged, female, male, transcranial magnetic stimulation, young adult, major depressive disorder
14 autores
- Dan Vlad Iosifescu🇺🇸Nathan Kline Institute for Psychiatric Research; NYU Langone Health; New York University
- Richard J. Norton🇺🇸University of Vermont
- Ümit Tural🇺🇸Nathan Kline Institute for Psychiatric Research
- David Mischoulon🇺🇸Harvard University; Massachusetts General Hospital
- Katherine Anne Collins🇺🇸Nathan Kline Institute for Psychiatric Research
- Erin McDonald🇺🇸Nathan Kline Institute for Psychiatric Research
- Luis H. De Taboada
- Simmie L. Foster🇺🇸Harvard University; Massachusetts General Hospital
- Cristina Cusin🇺🇸Harvard University; Massachusetts General Hospital
- Albert Yeung🇺🇸Harvard University; Massachusetts General Hospital
- Alisabet J. Clain🇺🇸Harvard University; Massachusetts General Hospital
- David Schoenfeld🇺🇸Harvard University; Massachusetts General Hospital
- Michael R. Hamblin🇿🇦University of Johannesburg
- Paolo Cassano🇺🇸Harvard University; Massachusetts General Hospital
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background: Transcranial photobiomodulation (t-PBM) with near-infrared (NIR) light might represent a treatment for major depressive disorder (MDD). However, the dosimetry of administered t-PBM varies widely. We tested the efficacy of t-PBM with low irradiance, low energy per session, and low number of sessions in individuals with MDD.Methods: A 2-site, double-blind, sham-controlled study was conducted of adjunct t-PBM NIR (830 nm; continuous wave; 35.8 cm2 treatment area; 54.8 mW/cm2 irradiance; 65.8 J/cm2 fluence, 20 min/session; ~2 W total power; 2.3 kJ total energy per session), delivered to the prefrontal cortex, bilaterally, twice a week for 6 weeks, in subjects diagnosed with MDD per the DSM-IV criteria. Subjects were recruited between August 2016 and May 2018. A sequential parallel comparison design was used: 18 nonresponders to sham in phase 1 (6 weeks) were re-randomized in phase 2. The primary outcome was reduction in depression severity (Hamilton Depression Rating Scale [HDRS-17] and Quick Inventory of Depressive Symptomatology-Clinician Rating [QIDS-C] scores) from baseline. Statistical analyses used R package SPCDAnalyze2, including all subjects with ≥ 1 post-randomization evaluation.Results: Of the 54 subjects recruited, we included 49 MDD subjects in the analysis (71% female, mean ± SD age 40.8 ± 16.1 years). There were no significant differences between t-PBM and sham with respect to the change in HDRS-17 (t = -0.319, P = .751) or QIDS-C (t = -0.499, P = .620) scores. The sham effect was reasonably low.Conclusions: Mostly uncontrolled studies suggest the efficacy of t-PBM for MDD; however, its optimal dose is still to be defined. A minimal dose threshold is likely necessary, similarly to other neuromodulation techniques in MDD (electroconvulsive therapy, transcranial magnetic stimulation). We established a threshold of inefficacy of t-PBM for MDD, based on combined low irradiance, low energy per session, and low number of sessions.Trial Registration: ClinicalTrials.gov identifier: NCT02959307.
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