Causal relationship between circulating vitamin C and 25-hydroxyvitamin D concentrations and common mental disorders-a Mendelian randomization study

Mental disorders seriously affect people’s health and social stability.This Mendelian randomization(MR)study was designed to investigate the causal relationship between circulating vitamin C(VC)or 25-hydroxyvitamin D(25(OH)D)levels and mental disorders.The data used for the MR analysis were derived from the summary genome-wide association studies(GWAS)database for VC and 25(OH)D and from the Finn Gen consortium for fourteen mental disorders.Based on the inverse variance weighted(IVW)method,we found a potential causal association between circulating VC and anxiety disorders(IVW:OR=1.139,95%CI:1.023-1.269,P=0.018).However,no causal association was found between VC or 25(OH)D and other mental disorders(P>0.05).In the reverse MR analysis,individuals with Alzheimer’s disease was causally associated with higher concentrations of circulating VC(P=0.012),while individuals with anxiety disorders had a negative association between the concentrations of 25(OH)D(P=0.012).However,the current evidence does not support a causal relationship between VC or 25(OH)D and other mental disorders.In addition,there was no causal association between circulating VC and 25(OH)D(P>0.05).Future studies are needed to confirm these findings and to elucidate the mechanisms of potential causality.

K^(+) channel-mediated retarded maturation of interneurons and its role in neurodevelopmental disorders

De novo mutations in genes encoding K^(+)channels are implicated in many severe neurodevelopmental disorders.Specifically,mutations in KCNA2,encoding the Shaker-type voltage-gated K^(+)channel Kv1.2,and KCNJ2,encoding the inwardly rectifying K^(+)channel Kir2.1,associate with focal and generalized epilepsies,brain atrophy,autism,ataxia and hereditary spastic paraplegia(Syrbe et al.,2015;Masnada et al.,2017;Cheng et al.,2021).

Exploring the influences of education,intelligence and income on mental disorders

Background Previous studies have shown that educational attainment(EA),intelligence and income are key factors associated with mental disorders.However,the direct effects of each factor on major mental disorders are unclear.Aims We aimed to evaluate the overall and independent causal effects of the three psychosocial factors on common mental disorders.Methods Using genome-wide association study summary datasets,we performed Mendelian randomisation(MR)and multivariable MR(MVMR)analyses to assess potential associations between the 3 factors(EA,N=766345;household income,N=392422;intelligence,N=146808)and 13 common mental disorders,with sample sizes ranging from 9907 to 807553.Inverse-variance weighting was employed as the main method in the MR analysis.Results Our MR analysis showed that(1)higher EA was a protective factor for eight mental disorders but contributed to anorexia nervosa,obsessive-compulsive disorder(OCD),bipolar disorder(BD)and autism spectrum disorder(ASD);(2)higher intelligence was a protective factor for five mental disorders but a risk factor for OCD and ASD;(3)higher household income protected against 10 mental disorders but confers risk for anorexia nervosa.Our MVMR analysis showed that(1)higher EA was a direct protective factor for attention-deficit/hyperactivity disorder(ADHD)and insomnia but a direct risk factor for schizophrenia,BD and ASD;(2)higher intelligence was a direct protective factor for schizophrenia but a direct risk factor for major depressive disorder(MDD)and ASD;(3)higher income was a direct protective factor for seven mental disorders,including schizophrenia,BD,MDD,ASD,post-traumatic stress disorder,ADHD and anxiety disorder.Conclusions Our study reveals that education,intelligence and income intertwine with each other.For each factor,its independent effects on mental disorders present a more complex picture than its overall effects.

Need for education of psychiatric evaluation of offenders with mental disorders:A questionnaire survey for Japanese designated psychiatrists

BACKGROUND The management of offenders with mental disorders has been a significant concern in forensic psychiatry.In Japan,the introduction of the Medical Treatment and Supervision Act in 2005 addressed the issue.However,numerous psychiatric patients at risk of violence still find themselves subject to the administrative involuntary hospitalization(AIH)scheme,which lacks clarity and updated standards.AIM To explore current as well as optimized learning strategies for risk assessment in AIH decision making.METHODS We conducted a questionnaire survey among designated psychiatrists to explore their experiences and expectations regarding training methods for psychiatric assessments of offenders with mental disorders.RESULTS The findings of this study’s survey suggest a prevalent reliance on traditional learning approaches such as oral education and on-the-job training.CONCLUSION This underscores the pressing need for structured training protocols in AIH consultations.Moreover,feedback derived from inpatient treatment experiences is identified as a crucial element for enhancing risk assessment skills.

Brain Research on Mental Disorders: A Criticism

Objective: To expose the problems and inherent limitations of neuroscience-based brain research on mental disorders. Method: Discussion of the theory underlying brain research on mental disorders, followed by a systematic evaluation of typical studies. Results: The fundamental problem is that brain researchers fail to differentiate between biological mental disorders in which brain processes cause the disorder (notably schizophrenia, bipolar disorder, and melancholic depression) and learned mental disorders in which brain processes mediate but do not cause the disorder (which is the case with reactive depression, reactive anxiety, OCD, and PTSD). Researchers have been unsuccessful in identifying mechanisms in the brain that cause biological mental disorders, and will never be able to locate the innumerable specific neural connections that mediate learned mental disorders. Moreover, the author’s review of typical studies in this field shows that they have serious problems with theory, measurement, and data analysis, and that their findings cannot be trusted. Conclusions: Neuroscience-based brain research on mental disorders, unlike other neurological research, has been an expensive failure and it is not worth continuing.

Internet Gaming Disorder and Mental Health of Children in China:A Latent Profile Analysis

In recent years,speculation of an increase in Internet Gaming Disorder(IGD)has surfaced with the growing popularity of internet gaming among Chinese children and adolescents.The detrimental impact of IGD on mental health cannot be denied,even though only a small portion of the screen-dependent population exhibits psychopathological and behavioral symptoms.The present study aimed to explore a latent profile analysis(LPA)of Internet Gaming Disorder on the mental health of Chinese school students.The data were collected from a sample of 1005 Chinese school students(49.8%male;age M=13.32,SD=1.34 years)using a paper-pencil survey through convenience sampling.LPA explored three latent profiles of internet gamers:regular gamers(62.4%),moderate gamers(28.1%),and probable disordered gamers(9.4%).Results showed that the probable disordered gamers had significantly higher levels of depression,anxiety,emotional and conduct problems,hyperactivity,and peer problem symptoms as well as lower life satisfaction,and pro-social symptoms compared to regular and moderate gamers(p<0.05).This study would be helpful to mental health professionals in designing interventions for gamers who present IGD symptoms.Future longitudinal studies should also be undertaken to assess whether mental health worsens for probable disordered gamers.

Evidence-Based Design Application of Water Landscaping for Rehabilitation Gardens for Patients with Mental Disorders

The aim of the article is to explore the influence of the water landscape design of a rehabilitation garden for patients with mental disorders on the recovery effect of patients,intending to provide a better rehabilitation environment for patients with mental disorders.Based on literature research,this article reviews three aspects of evidence-based design theory,the concept of water landscape in rehabilitation gardens,and the types of water features in rehabilitation gardens.The results show that well-designed water features can significantly improve patients’psychological state and reduce anxiety and stress,and that water landscape design in rehabilitation gardens is an effective rehabilitation tool that can facilitate the recovery process of patients with mental disorders.Future designs should take into full consideration patients’needs and preferences,as well as best practices in waterscape design,to maximize its positive impact on patients’recovery.

Mental emotional disorder is a predictor of stroke incidence in adults:Ten year results of the Bogor Cohort Study on Non-Communicable Disease Risk Factors in Indonesia

Objective:To determine the stroke predictors for the 10-year of follow-up in Bogor City,Indonesia.Methods:The prospective study analyzed the data of 4445 stroke-free subjects aged 25 years and above that was part of"the Bogor Cohort Study on Non-Communicable Disease Risk Factors".Data were collected by interview method with structured questionnaires,physical measurements three times a year,and laboratory examination every two years during a 10-year follow-up(2011-2021,without examination in 2020).The incidence of stroke is based on anamnesis results and examination by a neurologist.Other stroke predictor variables include characteristics,biological conditions,and risk behavior.We analysed 4445 stroke-free samples with Cox proportional hazard regression test.Results:During the 10-year observation,stroke incidence was 440 person-years per 100000 population(95%CI 370-530).During the follow-up of ten years,the main predictor of stroke was mental-emotional disorders with HR 4.2(95%CI 2.8-6.3)after adjustment by age,hypertension,obesity,abdominal obesity,and high LDL-cholesterol levels.Conclusions:Mental-emotional disorders are the strongest predictor of stroke incidence.Hence,psychological factors must be controlled in a stroke prevention program.

Aquaporin-4-IgG-seropositive neuromyelitis optica spectrum disorders:progress of experimental models based on disease pathogenesis

Neuromyelitis optica spectrum disorders are neuroinflammatory demyelinating disorders that lead to permanent visual loss and motor dysfunction.To date,no effective treatment exists as the exact causative mechanism remains unknown.Therefore,experimental models of neuromyelitis optica spectrum disorders are essential for exploring its pathogenesis and in screening for therapeutic targets.Since most patients with neuromyelitis optica spectrum disorders are seropositive for IgG autoantibodies against aquaporin-4,which is highly expressed on the membrane of astrocyte endfeet,most current experimental models are based on aquaporin-4-IgG that initially targets astrocytes.These experimental models have successfully simulated many pathological features of neuromyelitis optica spectrum disorders,such as aquaporin-4 loss,astrocytopathy,granulocyte and macrophage infiltration,complement activation,demyelination,and neuronal loss;however,they do not fully capture the pathological process of human neuromyelitis optica spectrum disorders.In this review,we summarize the currently known pathogenic mechanisms and the development of associated experimental models in vitro,ex vivo,and in vivo for neuromyelitis optica spectrum disorders,suggest potential pathogenic mechanisms for further investigation,and provide guidance on experimental model choices.In addition,this review summarizes the latest information on pathologies and therapies for neuromyelitis optica spectrum disorders based on experimental models of aquaporin-4-IgG-seropositive neuromyelitis optica spectrum disorders,offering further therapeutic targets and a theoretical basis for clinical trials.

Function and dysfunction of GEMIN5:understanding a novel neurodevelopmental disorder

The recent identification of a neurodevelopmental disorder with cerebellar atrophy and motor dysfunction(NEDCAM)has resulted in an increased interest in GEMIN5,a multifunction RNA-binding protein.As the largest member of the survival motor neuron complex,GEMIN5 plays a key role in the biogenesis of small nuclear ribonucleoproteins while also exhibiting translational regulatory functions as an independent protein.Although many questions remain regarding both the pathogenesis and pathophysiology of this new disorder,considerable progress has been made in the brief time since its discovery.In this review,we examine GEMIN5 within the context of NEDCAM,focusing on the structure,function,and expression of the protein specifically in regard to the disorder itself.Additionally,we explore the current animal models of NEDCAM,as well as potential molecular pathways for treatment and future directions of study.This review provides a comprehensive overview of recent advances in our understanding of this unique member of the survival motor neuron complex.

Bibliographical Review on Rehabilitation of Executive Functions in Patients With Developmental Coordination Disorder(DCD)

The present study aims to establish a literature review on intervention programs for executive functions(EFs)through the use of fundamental motor skills,from a neuropsychopedagogical perspective in subjects with Developmental Coordination Disorder(DCD).An exploratory study was carried out through an integrative literature review.The research was carried out in the Scientific databases Electronic Library Online(SciELO),Latin American and Caribbean Literature in Health Sciences(LILACS),Virtual Health Library-Psychology Brazil(BVSPSI),Electronic Journals of Psychology(PePSIC),in the periodicals available in the Brazilian Digital Library of Theses and Dissertations(BDTD)and on the website of the Coordination for the Improvement of Higher Education Personnel(CAPES).The covering publications took place from 2018 to 2023,14 articles were selected for analysis.This literature review made it possible to create strategies for stimulating EF and Visuomotor Functions so that educators and other professionals can better deal with students with DCD.It was perceived the need to carry out and develop more empirical research regarding the intervention of EFs and Visuomotor Functions by educators and professionals,with a greater sampling amplitude,to increase the number of studies that enable interventions both in children and in teenagers with DCD.

Adherence to 24-hour movement guidelines in children with mental,behavioral,and developmental disorders:Data from the 2016-2020 National Survey of Children's Health

Background:Adopting a healthy lifestyle during childhood could improve physical and mental health outcomes in adulthood and reduce relevant disease burdens.However,the lifestyles of children with mental,behavioral,and developmental disorders(MBDDs)remains under-described within the literature of public health field.This study aimed to examine adherence to 24-hour movement guidelines among children with MBDDs compared to population norms and whether these differences are affected by demographic characteristics.Methods:Data were from the 2016-2020 National Survey of Children’s Health—A national,population-based,cross-sectional study.We used the data of 119,406 children aged 6-17 years,which included 38,571 participants with at least 1 MBDD and 80,835 without.Adherence to the 24-hour movement guidelines was measured using parent-reported physical activity,screen time,and sleep duration.Results:Among children with MBDDs,20.3%,37.0%,60.7%,and 77.3%met the physical activity,screen time,sleep,and at least 1 of the 24-hour movement guidelines.These rates were lower than those in children without MBDDs(22.8%,46.2%,66.7%,and 83.4%,respectively;all p<0.001).Children with MBDDs were less likely to meet these guidelines(odds ratio(OR)=1.21,95%confidence interval(95%CI):1.13-1.30;OR=1.37,95%CI:1.29-1.45;OR=1.29,95%CI:1.21-1.37;OR=1.45,95%CI:1.35-1.56)than children without MBDDs.Children with emotional disorders had the highest odds of not meeting these guidelines(OR=1.43,95%CI:1.29-1.57;OR=1.48,95%CI:1.37-1.60;OR=1.49,95%CI:1.39-1.61;OR=1.72,95%CI:1.57-1.88)in comparison to children with other MBDDs.Among children aged12-17 years,the difference in proportion of meeting physical activity and screen time guidelines for children with vs.children without MBDD was larger than that among children aged 6-11 years.Furthermore,the above difference of meeting physical activity guidelines in ethnic minority children was smaller than that in white children.Conclusion:Children with MBDDs were less likely to meet individual or combined 24-hour movement guidelines than children without MBDDs.In educational and clinical settings,the primary focus should be on increasing physical activity and limiting screen time in children aged 12-17 years who have MBDDs;and specifically for white children who have MBDDs,increasing physical activity may help.

Real-world effectiveness and safety of direct-acting antivirals in hepatitis C virus patients with mental disorders

BACKGROUND It is estimated that 58 million people worldwide are infected with the hepatitis C virus(HCV).Patients with severe psychiatric disorders could not be treated with previously available interferon-based therapies due to their unfavorable side effect profile.This has changed with the introduction of direct-acting antivirals(DAA),although their real-life tolerance and effectiveness in patients with different psychiatric disorders remain to be demonstrated.AIM To evaluate the effectiveness and safety of DAA in patients with various mental illnesses.METHODS This was a retrospective observational study encompassing 14272 patients treated with DAA for chronic hepatitis C in 22 Polish hepatology centers,including 942 individuals diagnosed with a mental disorder(anxiety disorder,bipolar affective disorder,depression,anxiety-depressive disorder,personality disorder,schizophrenia,sleep disorder,substance abuse disorder,and mental illness without a specific diagnosis).The safety and effectiveness of DAA in this group were compared to those in a group without psychiatric illness(n=13330).Antiviral therapy was considered successful if serum ribonucleic acid(RNA)of HCV was undetectable 12 wk after its completion[sustained virologic response(SVR)].Safety data,including the incidence of adverse events(AEs),serious AEs(SAEs),and deaths,and the frequency of treatment modification and discontinuation,were collected during therapy and up to 12 wk after treatment completion.The entire study population was included in the intent-to-treat(ITT)analysis.Per-protocol(PP)analysis concerned patients who underwent HCV RNA evaluation 12 wk after completing treatment.RESULTS Among patients with mental illness,there was a significantly higher percentage of men,treatmentnaive patients,obese,human immunodeficiency virus and hepatitis B virus-coinfected,patients with cirrhosis,and those infected with genotype 3(GT3)while infection with GT1b was more frequent in the population without psychiatric disorders.The cure rate calculated PP was not significantly different in the two groups analyzed,with a SVR of 96.9% and 97.7%,respectively.Although patients with bipolar disorder achieved a significantly lower SVR,the multivariate analysis excluded it as an independent predictor of treatment non-response.Male sex,GT3 infection,cirrhosis,and failure of previous therapy were identified as independent negative predictors.The percentage of patients who completed the planned therapy did not differ between groups with and without mental disorders.In six patients,symptoms of mental illness(depression,schizophrenia)worsened,of which two discontinued treatments for this reason.New episodes of sleep disorders occurred significantly more often in patients with mental disorders.Patients with mental illness were more frequently lost to follow-up(4.2%vs 2.5%).CONCLUSION DAA treatment is safe and effective in HCV-infected patients with mental disorders.No specific psychiatric diagnosis lowered the chance of successful antiviral treatment.

Diabetes mellitus type 2 as an underlying,comorbid or consequent state of mental disorders

Somatic disturbances that occur in parallel with psychiatric diseases are a major challenge in clinical practice.Various factors contribute to the development of mental and somatic disorders.Type 2 diabetes mellitus(T2DM)is a significant health burden worldwide,and the prevalence of diabetes in adults is increasing.The comorbidity of diabetes and mental disorders is very common.By sharing a bidirectional link,both T2DM and mental disorders influence each other in various manners,but the exact mechanisms underlying this link are not yet elucidated.The potential mechanisms of both mental disorders and T2DM are related to immune and inflammatory system dysfunction,oxidative stress,endothelial dysfunction,and metabolic disturbances.Moreover,diabetes is also a risk factor for cognitive dysfunction that can range from subtle diabetesassociated cognitive decline to pre-dementia and dementia.A complex relationship between the gut and the brain also represents a new therapeutic approach since gut-brain signalling pathways regulate food intake and hepatic glucose production.The aim of this minireview is to summarize and present the latest data on mutual pathogenic pathways in these disorders,emphasizing their complexity and interweaving.We also focused on the cognitive performances and changes in neurodegenerative disorders.The importance of implementing integrated approaches in treating both of these states is highlighted,along with the need for individual therapeutic strategies.

Psychological and Physiological Health Benefits of a Structured Forest Therapy Program for Children and Adolescents with Mental Health Disorders

Mental health conditions in children and adolescents can be improved by slow mindful nature connection known as forest therapyor bathing.Forest therapy has recently received growing attention as an enabler of relaxation and preventive health care withdemonstrated clinical efficacy.However,it is not well-known that forest therapy also decreases mental health issues amongindividuals with mental health disorders.This study explored the psychological and physiological health benefits of structuredforest therapy programs for children and adolescents with mental health disorders.A one-group pre-test-posttest design wasemployed for our study participants.Twelve participants(aged 9–14 years)engaged in two one-hour guided standard sequenceforest therapy experiences.A Mindful Attention Awareness Scale(MAAS),Connectedness to Nature Scale(CNS),Profile ofMood States(POMS),place meanings(e.g.,functional,emotional,and cognitive attachment to the forest)questionnaire,andphysiological health assessment were administered to the participants.Our results showed that negative mood states weresignificantly reduced and that a positive mood state was significantly improved after the structured forest therapy programs.Also,mindfulness,nature connection,place meanings,and physiological health were significantly boosted after theinterventions.The results demonstrate substantial psychological and physiological health and well-being outcomes ofstructured forest therapy for similar individuals.

The Relationship between Mental Disorders and Personality of Outpatients in a Psychiatric Clinic in Nanjing, China

Psychosis has increasingly become a social problem,emphasizing the need to understand the relationship between mental disorders and personality.This study aimed to investigate the relationship between mental disorders and personality among psychiatric outpatients based on real-world data.Symptom Checklist 90(SCL-90)and Eysenck Personality Questionnaire(EPQ)were used to evaluate the personality and psychopathological symptoms of patients(n=8409)in the Psychiatric Outpatient Department at Nanjing Drum Tower Hospital.t-test was used to compare scores between patients and national norms.Pearson’s correlation coefficient and path analysis were used to explore the relationship between mental health status and personality.The correlation coefficient between the neuroticism(N)score and each factor score of the SCL-90 test,as well as the correlation between psychoticism(P)and hostility and paranoia,exceeded 0.4.Path analysis revealed that the standardized path coefficients of N score and SCL-90 were all higher than 0.4.In addition,the standardized path coefficient of hostility and paranoia on P score were 0.313 and 0.280,respectively.Interpersonal sensitivity,depression and obsessive-compulsive symptoms were affected by extraversion(E)score,with standardized path coefficients of-0.149,-0.138,and-0.105,respectively.The path analysis also showed the direct and indirect effects of age,gender,education,and marital status on SCL-90.Patients characterized as melancholic had higher scores in all factors of SCL-90.In conclusion,mental health was related to personality traits of neuroticism,psychoticism and introversion.

Progress in Application of CBT Therapy in Patients with Post-stroke Mental Disorders

The application effects of CBT therapy in patients with post-stroke mental disorders were summarized to better understand the application effects of CBT therapy in patients with post-stroke mental disorders,so as to provide reference suggestions for better providing psychological treatment to patients with post-stroke mental disorders.

Clinical Profile of Women with Mental Disorders in Dakar Hospitals

Introduction: In Senegal, knowledge of the clinical profile of mental disorders in women has not been the subject of many studies, even though it is of vital importance to those involved in mental health. Thus, the aim of our study was to describe the clinical aspects of psychiatric disorders in women hospitalized at Fann. Methodology: This was a cross-sectional, retrospective, and descriptive study over a five-year period. We identified 402 cases that met the selection criteria. The data collection form provided information on aspects of the clinical profile of mental disorders, such as medical, surgical, gynecological, obstetrical and psychiatric history, instigator of the request for care, diagnosis, duration and number of hospitalizations. ICD-10 was used for the various pathologies identified. Results: Asthma was noted in 7% of patients, as was hypertension. Gynecological surgery was found in 43 patients (11%). Eight patients were menopausal (2%). The mean number of gestations was 2.09, with a standard deviation of 2.257 and extremes between 0 and 10 gestations. Patients with a history of abortion numbered 58 (14%). The decision to hospitalize the patients was made by 96% (384 patients) of those around them. Hetero aggression was the most recurrent reason for hospitalization (19%). Pathology group F20-29 (schizophrenia, schizotypal disorder, and delusional disorders) was the majority group. Conclusion: The clinical profile of the mentally ill woman in Dakar is a woman in her mid-forties who most often presents with a personal psychiatric history, and her hospitalization is prompted by hetero-aggression and/or logorrhea. She usually suffers from schizophrenia and related disorders. Hospitalization usually lasts between 11 and 20 days.

Epidemiological Profile of Women with Mental Disorders in Hospital in Dakar

Introduction: Women are currently more likely than men to suffer from mental health problems. The prevalence of mental health problems among women is also increasing. However, few studies conducted in Africa provide epidemiological data on women. The aim of this study was to describe the epidemiological profile of women with mental health problems in Dakar. Methodology: This was a cross-sectional, retrospective, descriptive study over a five-year period, from 1 January 2017 to 31 December 2021. It concerned all women hospitalised for psychiatric reasons at the Psychiatry Department of Fann Hospital, Dakar, Senegal. The data collection form provided information on the sociodemographic profile, i.e., age, current address, marital status, ethnicity, religion, level of education, professional activity, and use of psychoactive substances. Results: The prevalence of mental disorders was 34.9% and concerned the following ICD-10 pathology groups [F00 - 09], [F10 - F19], [F20 - F29], [F30 - F39], [F40 - 48], [F50 - F59] and [F60 - F69]. The mean age of the patients was 37 years, with a standard deviation of 13 and extremes from 16 to 74 years. Most patients were unmarried (56%). Among the married patients, the monogamous regime was in the majority in our study: 56% compared with 44% for the polygamous regime. Women had to attend French school in 74% of cases. In our study, 32% of patients had reached university level. The majority were unemployed (67%). The notion of mourning was found in 214 patients (30.2%). The birth of one or more children marked the lives of 184 patients (26%). Divorce was noted in 103 patients (14.5%). Marital conflicts were experienced by 94 patients (13.3%). Twenty percent of the patients had used psychoactive substances. Conclusion: The epidemiological profile of a woman with a mental disorder in Dakar is that of a single woman in her forties who had attended university and was a housewife. She does not use psychoactive substances and has experienced at least one mourning in her life.

Psychedelic Drug Therapy for Mental Disorders?

Objective: Psychedelic drug therapy is banned in all countries of the world except Australia, where the government regulatory watchdog, the Therapeutic Goods Administration, is planning to allow approved psychiatrists, as of July 1, 2023, to prescribe psilocybin to treat depression and MDMA to treat post-traumatic stress disorder, a move precipitated by the U.S. Food and Drug Administration’s designation of these two drugs as “breakthrough therapy”. The objective of the present article is to demonstrate that the evidence on which the FDA and then the TGA relied is irretrievably flawed and should be dismissed. Method: Expert review of psychedelic therapy clinical trials and specifically of the methodology and measures used. Results: The present review demonstrates that the studies the U.S. FDA and the Australian TGA relied on to approve these two psychedelic drugs for therapy are irretrievably flawed. All future trials will follow the same procedure and are therefore bound to be flawed as well. Conclusions: Psychedelic drug studies have so far provided no trustworthy evidence of their effectiveness for treating mental disorders and are not likely to produce this evidence in the future. Psychedelic drug therapy is in any event impractical because of its specialized training requirements and very high treatment costs. It is also dangerous because false publicity about its effectiveness will almost certainly lead to unsupervised self-dosing with drugs that not only are illegal but have an unacceptably high addiction rate.