Randomized Controlled Trials of Psilocybin-Assisted Therapy in the Treatment of Major Depressive Disorder: Systematic Review and Meta-Analysis.

Introduction: There is growing interest in the use of psychedelic-assisted therapy (PAT) for major depressive disorder (MDD), including treatment-resistant depression. We used randomized controlled trial (RCT) data to compare summary estimates of change in depression ratings with PAT versus comparator treatments in MDD. We also compared response and remission rates, and adverse effects.

Poorly Recognized and Uncommonly Acknowledged Limitations of Randomized Controlled Trials.

Randomized controlled trials (RCTs) are a gold standard in evidence-based research. However, RCTs have limitations, among which the most commonly acknowledged is that narrow study selection criteria compromise the external validity of the findings. This article briefly touches upon this and other well-recognized limitations and presents, in greater detail, less commonly acknowledged limitations with examples from contemporary literature.

Towards a Further Understanding of Meta-Analysis Using Gestational Exposure to Cannabis and Birth Defects as a Case in Point.

About 5%-10% of pregnancies in the US are exposed to cannabis with highest use reported during the first trimester. Two recent meta-analyses presented estimates of the risk of birth defects associated with prenatal exposure to cannabis; the larger and more recent meta-analysis pooled data from 18 cohort and 18 case-control studies with a total sample size of >19 million subjects. The meta-analyses found that prenatal exposure to cannabis was associated with a small but statistically significant increased risk of any birth defect (pooled odds ratios [ORs], 1.

Exposure of Pregnancy to Pregestational Diabetes, Gestational Diabetes, and Antidiabetic Medications With Especial Focus on Major Congenital and Cardiac Malformations in Offspring.

The global prevalence of type 2 diabetes mellitus (T2DM) is increasing. T2DM is more common in patients with psychiatric disorders and those who take certain psychotropic drugs. T2DM occurs in 2%-7% of women of reproductive age.

Regression: Understanding What Covariates and Confounds Do in Adjusted Analyses.

The use of regression analysis is common in research. This article presents an introductory section that explains basic terms and concepts such as independent and dependent variables (IVs and DVs), covariates and confounds, zero-order correlations and multiple correlations, variance explained by variables and shared variance, bivariate and multivariable linear regression, line of least squares and residuals, unadjusted and adjusted analyses, unstandardized () and standardized (β) coefficients, adjusted , interaction terms, and others. Next, this article presents a more advanced section with the help of 3 examples; the raw data files for these examples are included in supplementary materials, and readers are encouraged to download the data files and run the regressions on their own in order to better follow what is explained in the text (this, however, is not mandatory, and readers who do not do so can also follow the discussions in the text).

Therapeutic Effects, Side Effects, and Adverse Effects of Neuropsychiatric Drugs in the Context of Treating Cancer-Related Anorexia With Olanzapine and Mirtazapine.

Drugs have actions that may be classified as therapeutic effects and side effects; side effects are actions that do not contribute to therapeutic benefit. Some side effects are neutral; others, experienced as undesirable or unpleasant, are recorded as adverse effects. Some drug actions are therapeutic for some disorders and adverse for others; or therapeutic during acute illness and adverse during maintenance treatment.

Aerobic Exercise: Randomized Controlled Trial Data Suggest Qualified Benefits for Erectile Dysfunction.

Erectile dysfunction (ED) refers to the difficulty in achieving and maintaining a degree of penile erection that suffices for satisfactory sexual activity. ED is multifactorial in origin; its prevalence therefore varies with the population studied. In the general population, ED is present in 18-52% of men in younger to older age groups and in 43-76% of men with different medical conditions.

A randomised, open-label, pragmatic pilot comparison of oral and intravenous ketamine in treatment-resistant depression.

Background: For depression, ketamine is more conveniently administered by oral than by intravenous (iv) routes. The relative antidepressant efficacy of oral vs iv ketamine is unknown.

Objectives: To assess the acute efficacy and the persistence of improvement with open-label oral versus iv ketamine in outpatients with treatment-resistant depression (TRD).

Curiosities in a Table: Learning Points for Responsible Clinical Rating.

This article presents a table containing redacted data from a real study. The table contains three curiosities: statistical significance in the absence of clinical significance, narrow standard deviations, and the absence of a placebo effect. The data in the table had been obtained by an inexperienced rater; how the inexperience compromised the data is explained.

Epilepsy, Antiepileptic Drugs, and Adverse Pregnancy Outcomes, 2: Major Congenital Malformations With Antiepileptic Drug Monotherapy.

Women with epilepsy (WWE) are usually advised antiepileptic drug (AED) treatment even during pregnancy. It is therefore important to know what the major congenital malformation (MCM) risks might be with untreated epilepsy, and with first-trimester exposure to different AEDs in monotherapy. This article reviews recent findings from a large multinational registry, a large multinational population based study, and a large meta-analysis.

Primary outcomes, secondary outcomes, and their relevance to how many papers are published from a study: A primer for authors, reviewers, and editors.

In research, outcomes are often categorized as primary and secondary. The primary outcome is the most important one; it determines whether the study is considered 'successful' or not. Secondary outcomes are chosen because they provide supporting evidence for the results of the primary outcome or additional information about the subject being studied.

Epilepsy, Antiepileptic Drugs, and Adverse Pregnancy Outcomes, 1: Examination and Interpretation of Recent Research.

The age-standardized global prevalence of epilepsy is about 0.3% in women. Seizures are associated with morbidity and mortality risks; so, women with epilepsy (WWE) are usually advised antiepileptic drug (AED) treatment even during pregnancy.

Antipsychotic Medication Continuation vs Taper and Discontinuation in Patients With Schizophrenia and Other Nonaffective Psychotic Disorders.

Schizophrenia is a major mental illness that is managed with long-term antipsychotic medication as a standard of care. Antipsychotic medications, however, are associated with many subjective and objective adverse effects. These adverse effects have driven the study of risk-mitigation strategies such as targeted intermittent therapy and dose reduction and drug discontinuation.

Gestational exposure to benzodiazepines or z-hypnotics and neurodevelopmental disorders in offspring: Systematic review and meta-analysis.

Introduction: Benzodiazepine (BDZP) and/or z-hypnotic dispensing during pregnancy has increased globally, as have rates of autism spectrum disorder (ASD) and attention-deficit hyperactivity disorder (ADHD). This systematic review and meta-analysis aimed to estimate the association between gestational exposure to BDZP and/or z-hypnotics and diagnosis of ASD or ADHD in offspring.

Methods: We searched MEDLINE, EMBASE, and SCOPUS from inception till December 2023 for relevant English-language articles.

Understanding Factorial Designs, Main Effects, and Interaction Effects: Simply Explained with a Worked Example.

A factorial design examines the effects of two independent variables on a single, continuous dependent variable. The statistical test employed to analyze the data is a two-way analysis of variance (ANOVA). This test yields three results: a main effect for each of the independent variables and an interaction effect between the two independent variables.

A review on the pharmacology of cariprazine and its role in the treatment of negative symptoms of schizophrenia.

Management of negative symptoms is one of the most challenging and important unmet needs of schizophrenia treatment. Negative symptoms together with positive symptoms result in significant psychosocial impairment and poor quality of life. Existing studies on atypical antipsychotics reported limited treatment adherence due to higher prevalence of treatment-emergent adverse events, such as diabetes, weight gain, hyperlipidemia, hyperprolactinemia and hypertension.

Rating Patients in Different Languages: Reliability and Validity.

Research outcomes in mental health disciplines are usually assessed using rating instruments that were developed as English language versions. However, in countries such as India, English is not the native language, and patients at even a single research center may speak in different regional tongues. It is permissible to assess such patients using rater-administered English language instruments designed to be scored after an unstructured interview conducted in the patient's preferred language.