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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.

SUBMITTER: Cassano P

PROVIDER: S-EPMC4556873 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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Near-Infrared Transcranial Radiation for Major Depressive Disorder: Proof of Concept Study.

Cassano Paolo P Cusin Cristina C Mischoulon David D Hamblin Michael R MR De Taboada Luis L Pisoni Angela A Chang Trina T Yeung Albert A Ionescu Dawn F DF Petrie Samuel R SR Nierenberg Andrew A AA Fava Maurizio M Iosifescu Dan V DV

Psychiatry journal 20150819

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 ...[more]

PMID: 26356811

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Project description:Background and Objective: Acupuncture is used as an alternative treatment for patients with major depressive disorder (MDD). The associated therapeutic effect of acupuncture is often attributed to its modulatory effect on the activity of the pre-frontal cortex (PFC), although the mechanism is not well-studied. We employed a repeated measures design to investigate the brain modulatory effect of acupuncture on the PFC in a group of patients with MDD and investigated whether the modulatory effect is influenced by the severity of the disease. Methods: A total of 47 patients diagnosed with MDD were enrolled in this functional near-infrared spectroscopy experiment. The severity of depressive symptoms was measured at baseline using the Hamilton Depression Rating Scale-24 (HAMD). The cortical activation in the bilateral PFC areas during a verbal fluency task (VFT) was measured before and after a single session of acupuncture in the Baihui acupoint. We further explored the potential correlation between the severity of MDD and task-related activation before and after acupuncture. Results: A single session of acupuncture significantly tended to enhance the activation level of the left frontopolar cortex in patients with severe depression during VFT, but a null effect was found in those with mild to moderate depression. Among patients with severe depression, a strong correlation was observed between HAMD scores and the change in VFT-related activation after acupuncture in the left dorsolateral PFC (DLPFC). Conclusion: A single session of acupuncture did not significantly modulate the activation of the left PFC in patients with mild to moderate depression; however, it demonstrated a tendency to enhance the activation of the frontopolar area in patients with severe depression. Among patients with severe depression, there is a correlation between the activation by acupuncture of left DLPFC during executive functioning and the severity of depressive symptoms, suggesting that the brain activity induced by acupuncture is likely to be influenced by the baseline disease severity in patients with MDD.

Project description:Background: Major Depressive Disorder (MDD) is a moderately heritable disorder with a high lifetime prevalence. At present, laboratory blood tests to support MDD diagnosis are not available. Methods: We used a classifier approach on blood gene expression profiles of a unique set of non-medicated subjects (MDD patients and controls) to select genes of which expression is predictive for disease status. To reveal blood gene expression changes related to MDD disease, we applied a powerful ex vivo stimulus to the blood, i.e. incubation with lipopolysaccharide (LPS; 10 ng/ml blood). Results: Based on LPS-stimulated blood gene expression using whole-genome microarrays in 42 subjects (primary cohort; 21 MDD patients (mean age 42.3 years), 21 healthy controls (mean age 41.9 years)), we identified a set of genes (CAPRIN1, CLEC4A, KRT23, MLC1, PLSCR1, PROK2, ZBTB16) that serves as a molecular signature of MDD. These findings were validated for the primary cohort using an independent quantitative PCR method (P = 0.007). The difference between depressive patients and controls was confirmed (P = 0.019) in a replication cohort of 13 patients with MDD (mean age 42.8 years) and 14 controls (mean age 45.6 years). The MDD-signature score comprised of expression levels of 7 genes could discriminate depressive patients from controls with sensitivity of 76.9% and specificity of 71.8%. Conclusions: We show for the first time that molecular analysis of stimulated blood cells can be used as an endophenotype for MDD diagnosis, which is a milestone in establishing biomarkers for neuropsychiatric disorders with moderate heritability in general. Our results may provide a new entry point for following and predicting treatment outcome, as well as prediction of severity and recurrence of MDD. In total, 33 MDD patients and 34 healthy controls were analyzed using basal gene expression in whole blood, and gene expression from whole blood that was stimulated with LPS for 5-6 h, using microarrays. Patients were arbitrarily selected from all patients to serve as primary cohort (nMDD = 21 (MDD01-MDD21); nControls = 21 (Con01-Con21)), or replication cohort (nMDD = 12 (MDD22-MDD35); nControls = 13 (Con22-Con37)) using microarrays. This submission does not include Samples CON21_LPS or CON30_LPS.

Project description:PurposeAberrantly expressed glycans in cancer are of particular interest for tumor targeting. This proof-of-concept in vivo study aims to validate the use of aberrant Lewis glycans as target for antibody-based, real-time imaging of gastrointestinal cancers.ProceduresImmunohistochemical (IHC) staining with monoclonal antibody FG88.2, targeting Lewisa/c/x, was performed on gastrointestinal tumors and their healthy counterparts. Then, FG88.2 and its chimeric human/mouse variant CH88.2 were conjugated with near-infrared fluorescent (NIRF) IRDye 800CW for real-time imaging. Specific binding was evaluated in vitro on human gastrointestinal cancer cell lines with cell-based plate assays, flow cytometry, and immune-fluorescence microscopy. Subsequently, mice bearing human colon and pancreatic subcutaneous tumors were imaged in vivo after intravenous administration of 1 nmol (150 μg) CH88.2-800CW with the clinical Artemis NIRF imaging system using the Pearl Trilogy small animal imager as reference. One week post-injection of the tracer, tumors and organs were resected and tracer uptake was analyzed ex vivo.ResultsIHC analysis showed strong FG88.2 staining on colonic, gastric, and pancreatic tumors, while staining on their normal tissue counterparts was limited. Next, human cancer cell lines HT-29 (colon) and BxPC-3 and PANC-1 (both pancreatic) were identified as respectively high, moderate, and low Lewisa/c/x-expressing. Using the clinical NIRF camera system for tumor-bearing mice, a mean tumor-to-background ratio (TBR) of 2.2 ± 0.3 (Pearl: 3.1 ± 0.8) was observed in the HT-29 tumors and a TBR of 1.8 ± 0.3 (Pearl: 1.9 ± 0.5) was achieved in the moderate expression BxPC-3 model. In both models, tumors could be adequately localized and delineated by NIRF for up to 1 week. Ex vivo analysis confirmed full tumor penetration of the tracer and low fluorescence signals in other organs.ConclusionsUsing a novel chimeric Lewisa/c/x-targeting tracer in combination with a clinical NIRF imager, we demonstrate the potential of targeting Lewis glycans for fluorescence-guided surgery of gastrointestinal tumors.

Dataset Information

Near-Infrared Transcranial Radiation for Major Depressive Disorder: Proof of Concept Study.

Publications

Near-Infrared Transcranial Radiation for Major Depressive Disorder: Proof of Concept Study.

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