title: Near-Infrared Transcranial Radiation for Major Depressive Disorder: Proof of Concept Study.
abstract: Transcranial near-infrared radiation (NIR) is an innovative treatment for major depressive disorder (MDD), but clinical evidence for its efficacy is limited. Our objective was to investigate the tolerability and efficacy of NIR in patients with MDD. We conducted a proof of concept, prospective, double-blind, randomized study of 6 sessions of NIR versus sham treatment for patients with MDD, using a crossover design. Four patients with MDD with mean age 47 ± 14 (SD) years (1 woman and 3 men) were exposed to irradiance of 700 mW/cm(2) and a fluence of 84 J/cm(2) for a total NIR energy of 2.40 kJ delivered per session for 6 sessions. Baseline mean HAM-D17 scores decreased from 19.8 ± 4.4 (SD) to 13 ± 5.35 (SD) after treatment (t = 7.905; df = 3; P = 0.004). Patients tolerated the treatment well without any serious adverse events. These findings confirm and extend the preliminary data on NIR as a novel intervention for patients with MDD, but further clinical trials are needed to better understand the efficacy of this new treatment. This trial is registered with ClinicalTrials.gov NCT01538199.
authors.affiliation: Depression Clinical & Research Program, Massachusetts General Hospital, Boston, MA 02114, USA.
authors.forename: Paolo
authors.initials: P
authors.lastname: Cassano
authors.affiliation: Depression Clinical & Research Program, Massachusetts General Hospital, Boston, MA 02114, USA.
authors.forename: Cristina
authors.initials: C
authors.lastname: Cusin
authors.affiliation: Depression Clinical & Research Program, Massachusetts General Hospital, Boston, MA 02114, USA.
authors.forename: David
authors.initials: D
authors.lastname: Mischoulon
authors.affiliation: Wellman Center for Photomedicine, Massachusetts General Hospital, Boston, MA 02114, USA.
authors.forename: Michael R
authors.initials: MR
authors.lastname: Hamblin
authors.affiliation: LiteCure LLC, Newark, DE 19702, USA.
authors.forename: Luis
authors.initials: L
authors.lastname: De Taboada
authors.affiliation: Depression Clinical & Research Program, Massachusetts General Hospital, Boston, MA 02114, USA.
authors.forename: Angela
authors.initials: A
authors.lastname: Pisoni
authors.affiliation: Depression Clinical & Research Program, Massachusetts General Hospital, Boston, MA 02114, USA.
authors.forename: Trina
authors.initials: T
authors.lastname: Chang
authors.affiliation: Depression Clinical & Research Program, Massachusetts General Hospital, Boston, MA 02114, USA.
authors.forename: Albert
authors.initials: A
authors.lastname: Yeung
authors.affiliation: Depression Clinical & Research Program, Massachusetts General Hospital, Boston, MA 02114, USA.
authors.forename: Dawn F
authors.initials: DF
authors.lastname: Ionescu
authors.affiliation: Depression Clinical & Research Program, Massachusetts General Hospital, Boston, MA 02114, USA.
authors.forename: Samuel R
authors.initials: SR
authors.lastname: Petrie
authors.affiliation: Depression Clinical & Research Program, Massachusetts General Hospital, Boston, MA 02114, USA.
authors.forename: Andrew A
authors.initials: AA
authors.lastname: Nierenberg
authors.affiliation: Depression Clinical & Research Program, Massachusetts General Hospital, Boston, MA 02114, USA.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Fava
authors.affiliation: Depression Clinical & Research Program, Massachusetts General Hospital, Boston, MA 02114, USA ; Department of Psychiatry, The Mount Sinai Hospital, New York, NY 10029, USA.
authors.forename: Dan V
authors.initials: DV
authors.lastname: Iosifescu