Prevalence and correlates of REM sleep behaviour disorder in patients with major depressive disorder: a two-phase study

2021 ◽  
pp. jnnp-2021-327460
Author(s):  
Jing Wang ◽  
Steven W H Chau ◽  
Siu Ping Lam ◽  
Yaping Liu ◽  
Jihui Zhang ◽  
...  
Keyword(s):  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Phase 1 ◽  
Behaviour Disorder ◽  
Major Depressive ◽  
Two Phase ◽  
Weighting Method ◽  
Male Predominance ◽  
Sleep Behaviour ◽  
Validated Questionnaire

ObjectiveTo investigate the prevalence and clinical correlates of video polysomnography (vPSG)-confirmed rapid eye movement sleep behaviour disorder (RBD) in patients with major depressive disorder (MDD).MethodsThis is a clinic-based two-phase epidemiological study. In phase 1, patients with MDD were screened by a validated questionnaire, RBD Questionnaire-Hong Kong (RBDQ-HK). In phase 2, a subsample of both the screen-positive (RBDQ-HK >20) and screen–negative patients with MDD underwent further clinical and sleep assessment (vPSG) to confirm the diagnosis of RBD (MDD+RBD). Poststratification weighting method was used to estimate the prevalence of MDD+RBD. The total likelihood ratio and the probability of prodromal Parkinson’s disease (PD) were calculated from prodromal markers and risk factors, as per the Movement Disorder Society research criteria.ResultsA total of 455 patients with MDD were screened (median age (IQR)=52.66 (15.35) years, 77.58% woman, 43.74% positive). Eighty-one patients underwent vPSG and 12 of them were confirmed MDD+RBD. The prevalence of MDD+RBD was estimated to be 8.77% (95% CI: 4.33% to 16.93%), with possibly male predominance. MDD+RBD were associated with colour vision and olfaction deficit and a higher probability for prodromal PD.ConclusionsAlmost 9% of patients with MDD in the psychiatric outpatient clinic has vPSG-confirmed RBD. Comorbid MDD+RBD may represent a subtype of MDD with underlying α-synucleinopathy neurodegeneration. Systematic screening of RBD symptoms and necessity of vPSG confirmation should be highlighted for capturing this MDD subtype with a view to enhance personalised treatment and future neuroprotection to prevent neurodegeneration.

scholarly journals Brexpiprazole: A review of a new treatment option for schizophrenia and major depressive disorder

2017 ◽  
Vol 7 (5) ◽  
pp. 207-212 ◽  
Author(s):  
Lauren A. Diefenderfer ◽  
Courtney Iuppa
Keyword(s):  
Clinical Trials ◽  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Partial Agonist ◽  
Adjunctive Treatment ◽  
Inadequate Response ◽  
Major Depressive ◽  
Two Phase ◽  
New Treatment

Abstract Brexpiprazole is an atypical antipsychotic that works as a partial agonist at serotonin 5-hydroxytryptamine1A and dopamine D2 receptors and an antagonist at serotonin 5-hydroxytryptamine2A. It has US Food and Drug Administration approval for monotherapy treatment of schizophrenia and adjunctive treatment to antidepressants for major depressive disorder. Two phase-3 clinical trials demonstrated efficacy and relatively fair tolerability with regard to adverse effects for each indication. Akathisia was frequently reported in the major depressive disorder trials but less so in the schizophrenia trials. Significant increases in body weight and triglycerides were seen across all studies. Brexpiprazole appears to be a viable option for treating an acute exacerbation of schizophrenia requiring hospitalization or adjunctive treatment of major depressive disorder in patients who showed an inadequate response to 1 to 3 antidepressants. Further clinical trials are warranted to determine the long-term efficacy of brexpiprazole, and comparison trials would be beneficial to establish its place in therapy.

scholarly journals The Safety, Efficacy, and Tolerability of Microbial Ecosystem Therapeutic-2 in People With Major Depressive Disorder and/or Generalized Anxiety Disorder: A Phase 1, Open-Label Study

2021 ◽  
Author(s):  
Arthi Chinna Meyyappan ◽  
Evan Forth ◽  
Roumen Milev
Keyword(s):  
Major Depressive Disorder ◽  
Anxiety Disorder ◽  
Adverse Events ◽  
Depressive Disorder ◽  
Phase 1 ◽  
Generalized Anxiety ◽  
Depression And Anxiety ◽  
Open Label ◽  
Major Depressive ◽  
Microbial Ecosystem

Abstract Background: Recent studies have investigated the potential of treatments that modify the gut microbiome, such as fecal microbiota transplantation (FMT) and probiotics, in individuals with psychiatric illnesses. The aim of this study was to investigate the safety, tolerability, and efficacy of a novel gut microbiome therapeutic, Microbial Ecosystem Therapuetic-2 (MET-2), in people with depression and anxiety. Methods: In this phase 1, open-label trial, twelve adults diagnosed with Major Depressive Disorder and/or Generalized Anxiety Disorder were recruited. Participants consumed orally once daily an encapsulated microbial therapeutic, containing 40 strains of bacteria purified and lab-grown from a single healthy donor stool, for 8 weeks. Participants were assessed biweekly using clinical scales and questionnaires in order to evaluate the safety, efficacy, and tolerability of the therapeutic. Results: The therapeutic was found to be generally safe and tolerable, with limited adverse events and side effects, and no serious adverse events. Of the twelve individuals included in this study, nine responded to treatment (50% improvement in MADRS and/or GAD-7 scores from baseline to week 8 visit). Over the course of 10 weeks MET-2 significantly decreased mean MADRS and GAD-7 scores, MADRS [F (5, 55) = 8.784, p<0.0001 and GAD-7 F (5,55) = 9.638, p<0.0001]. Conclusion: The findings of this study are the first to provide evidence for the role of microbial ecosystem therapy in treating depression and anxiety. However, a double-blind, randomized controlled trial with a larger sample size is needed for more conclusive results. Trial Registration: This study was registered with clinicaltrials.gov (NCT04052451) on 09/08/2019.

L-methylfolate augmentation of selective serotonin reuptake inhibitors (SSRIS) for major depressive disorder: Results of two randomized, double-blind trials

2011 ◽  
Vol 26 (S2) ◽  
pp. 592-592 ◽  
Author(s):  
G. Papakostas ◽  
R. Shelton ◽  
J. Zajecka ◽  
K. Rickels ◽  
A. Clain ◽  
...  
Keyword(s):  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Selective Serotonin Reuptake Inhibitors ◽  
Rating Scale ◽  
Phase 1 ◽  
Response Rates ◽  
Inadequate Response ◽  
Phase 2 ◽  
Major Depressive ◽  
Double Blind

IntroductionTwo randomized, controlled trials of L-methylfolate augmentation of SSRIs for major depressive disorder (MDD) were conducted using a novel study design (sequential parallel comparison design- SPCD).Objectives/aimsTo evaluate the efficacy of L-methylfolate augmentation using the Hamilton Depression Rating Scale.MethodsIn study one (TRD-1), 148 outpatients with SSRI-resistant MDD were enrolled in a 60-day, SPCD study, divided into two 30-day periods (phases 1 and 2). Patients were randomized 2:3:3 to receive L-methylfolate (7.5mg/d in phase 1, 15mg/d in phase 2), placebo in phase 1 followed by L-methylfolate 7.5mg/d in phase 2, or placebo for both phases. Study two (TRD-2) involved 75 patients and was identical in design to TRD-1 except for the dose of L-methylfolate (15mg only).ResultsIn the TRD-1 Study, L-methylfolate 7.5 mg/d was not found to be more effective than placebo. In phase 1 of the TRD-2 Study, 37% of patients on L-methylfolate 15mg/d responded and 18% of placebo patients responded, while in phase 2 among placebo non-responders, the response rates were 28% on L-methylfolate 15mg/d and 9.5% on placebo. When phases 1 and 2 were pooled according to the SPCD model, the difference in response rates was statistically significant in favor of L-methylfolate (p = 0.0399). The rates of spontaneously reported AEs and rates of study discontinuation appear r comparable between L-methylfolate and placebo in both studies. Rates of study discontinuation were also comparableConclusionsThese studies suggest that L-methylfolate 15 mg/d may be a safe and effective augmentation strategy for inadequate response to SSRIs.

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