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A placebo-controlled study of the effects of ayahuasca, set and setting on mental health of participants in ayahuasca group retreats
Ayahuasca is a plant concoction containing N,N-dimethyltryptamine (DMT) and certain β-carboline alkaloids from South America. Previous research in naturalistic settings has suggested that ingestion of ayahuasca can improve mental health and well-being; however, these studies were not placebo controlled and did not control for the possibility of expectation bias. This naturalistic observational study was designed to assess whether mental health changes were produced by ayahuasca or by set and setting. Assessments were made pre- and post-ayahuasca sessions in 30 experienced participants of ayahuasca retreats hosted in the Netherlands, Spain, and Germany. Participants consumed ayahuasca (N = 14) or placebo (N = 16). Analysis revealed a main effect of time on symptoms of depression, anxiety, and stress. Compared to baseline, symptoms reduced in both groups after the ceremony, independent of treatment. There was a main treatment × time interaction on implicit emotional empathy, indicating that ayahuasca increased emotional empathy to negative stimuli. The current findings suggest that improvements in mental health of participants of ayahuasca ceremonies can be driven by non-pharmacological factors that constitute a placebo response but also by pharmacological factors that are related to the use of ayahuasca. These findings stress the importance of placebo-controlled designs in psychedelic research and the need to further explore the contribution of non-pharmacological factors to the psychedelic experience.
Journal Article
Handbook of clinical psychopharmacology for therapists
\"The Handbook of Clinical Psychopharmacology for Therapists is the go-to resource for mental health clinicians looking for clear, reliable information about the treatment of mental health issues. Organized by disorder and, within each disorder, by medication, this book is designed to familiarize clinicians and students with the basic terminology and models of pharmacokinetics.This fully revised and updated eighth edition provides essential information on new medications and treatment options and includes the latest research on side effects, contraindications, and efficacy of all major medications prescribed for mental health disorders. The book also features an important new chapter on the effects of withdrawing from psychopharmacological medications.This handbook makes it simple to: get the facts about drug interactions and side effects; find out how medications affect adults, children, and adolescents differently; learn how different cultures view medical treatment; vital information for anyone who treats clients from a variety of backgrounds; and discontinue medication safely when needed.This essential guide to psychopharmacology has been adopted as a textbook at universities nationwide and is an important resource for every therapist's library\"-- Provided by publisher.
Book
Sertraline or mirtazapine for depression in dementia (HTA-SADD): a randomised, multicentre, double-blind, placebo-controlled trial
Depression is common in dementia but the evidence base for appropriate drug treatment is sparse and equivocal. We aimed to assess efficacy and safety of two of the most commonly prescribed drugs, sertraline and mirtazapine, compared with placebo.
We undertook the parallel-group, double-blind, placebo-controlled, Health Technology Assessment Study of the Use of Antidepressants for Depression in Dementia (HTA-SADD) trial in participants from old-age psychiatry services in nine centres in England. Participants were eligible if they had probable or possible Alzheimer's disease, depression (lasting ≥4 weeks), and a Cornell scale for depression in dementia (CSDD) score of 8 or more. Participants were ineligible if they were clinically critical (eg, suicide risk), contraindicated to study drugs, on antidepressants, in another trial, or had no carer. The clinical trials unit at King's College London (UK) randomly allocated participants with a computer-generated block randomisation sequence, stratified by centre, with varying block sizes, in a 1:1:1 ratio to receive sertraline (target dose 150 mg per day), mirtazapine (45 mg), or placebo (control group), all with standard care. The primary outcome was reduction in depression (CSDD score) at 13 weeks (outcomes to 39 weeks were also assessed), assessed with a mixed linear-regression model adjusted for baseline CSDD, time, and treatment centre. This study is registered, number ISRCTN88882979 and EudraCT 2006-000105-38.
Decreases in depression scores at 13 weeks did not differ between 111 controls and 107 participants allocated to receive sertraline (mean difference 1·17, 95% CI −0·23 to 2·58; p=0·10) or mirtazapine (0·01, −1·37 to 1·38; p=0·99), or between participants in the mirtazapine and sertraline groups (1·16, −0·25 to 2·57; p=0·11); these findings persisted to 39 weeks. Fewer controls had adverse reactions (29 of 111 [26%]) than did participants in the sertraline group (46 of 107, 43%; p=0·010) or mirtazapine group (44 of 108, 41%; p=0·031), and fewer serious adverse events rated as severe (p=0·003). Five patients in every group died by week 39.
Because of the absence of benefit compared with placebo and increased risk of adverse events, the present practice of use of these antidepressants, with usual care, for first-line treatment of depression in Alzheimer's disease should be reconsidered.
UK National Institute of Health Research HTA Programme.
Journal Article
Transcriptomics-informed large-scale cortical model captures topography of pharmacological neuroimaging effects of LSD
Psychoactive drugs can transiently perturb brain physiology while preserving brain structure. The role of physiological state in shaping neural function can therefore be investigated through neuroimaging of pharmacologically induced effects. Previously, using pharmacological neuroimaging, we found that neural and experiential effects of lysergic acid diethylamide (LSD) are attributable to agonism of the serotonin-2A receptor (Preller et al., 2018). Here, we integrate brain-wide transcriptomics with biophysically based circuit modeling to simulate acute neuromodulatory effects of LSD on human cortical large-scale spatiotemporal dynamics. Our model captures the inter-areal topography of LSD-induced changes in cortical blood oxygen level-dependent (BOLD) functional connectivity. These findings suggest that serotonin-2A-mediated modulation of pyramidal-neuronal gain is a circuit mechanism through which LSD alters cortical functional topography. Individual-subject model fitting captures patterns of individual neural differences in pharmacological response related to altered states of consciousness. This work establishes a framework for linking molecular-level manipulations to systems-level functional alterations, with implications for precision medicine.
Journal Article
Lives interrupted : psychiatric narratives of struggle and resilience
\"Based on interviews with individuals who struggle with severe psychic distress, contributors to this edited collection critique conventional pharmaceutical and medicalized treatment and argue for the need to create facilitative spaces in which psychosocial and familial supports are offered as adjuncts to therapy\"-- Provided by publisher.
Book
Cardiovascular risk factors and metabolic syndrome in people with established psychotic illnesses: baseline data from the IMPaCT randomized controlled trial
The aims of the study were to determine the prevalence of cardiometabolic risk factors and establish the proportion of people with psychosis meeting criteria for the metabolic syndrome (MetS). The study also aimed to identify the key lifestyle behaviours associated with increased risk of the MetS and to investigate whether the MetS is associated with illness severity and degree of functional impairment.
Baseline data were collected as part of a large randomized controlled trial (IMPaCT RCT). The study took place within community mental health teams in five Mental Health NHS Trusts in urban and rural locations across England. A total of 450 randomly selected out-patients, aged 18-65 years, with an established psychotic illness were recruited. We ascertained the prevalence rates of cardiometabolic risk factors, illness severity and functional impairment and calculated rates of the MetS, using International Diabetes Federation (IDF) and National Cholesterol Education Program Third Adult Treatment Panel criteria.
High rates of cardiometabolic risk factors were found. Nearly all women and most men had waist circumference exceeding the IDF threshold for central obesity. Half the sample was obese (body mass index ≥ 30 kg/m2) and a fifth met the criteria for type 2 diabetes mellitus. Females were more likely to be obese than males (61% v. 42%, p < 0.001). Of the 308 patients with complete laboratory measures, 57% (n = 175) met the IDF criteria for the MetS.
In the UK, the prevalence of cardiometabolic risk factors in individuals with psychotic illnesses is much higher than that observed in national general population studies as well as in most international studies of patients with psychosis.
Journal Article
Experimental pasta as an innovative approach to cholesterol reduction in patients with metabolic syndrome, with and without major psychiatric disorders: A randomized controlled trial supported by in vitro validation
Elevated non-high-density lipoprotein cholesterol (non-HDL-C) is a significant risk factor for atherosclerotic cardiovascular diseases, particularly in individuals with metabolic syndrome (MetS) and major psychiatric disorders (MPDs), who may experience metabolic side effects of psychopharmacological treatments. We evaluated the cholesterol-lowering effects of an experimental pasta characterized by a high content of phytosterols, arabinoxylans, polyunsaturated and monounsaturated fatty acids, and vitamin E in individuals with MetS, with and without MPDs.
In a double-blind, randomized trial, 298 participants with MetS were assigned to consume either experimental or conventional pasta for 3 months. Non-HDL-C levels were measured at baseline and follow-up. A polygenic risk score for hypercholesterolemia (TC-PRS) was calculated to assess any genetic influence on the intervention's efficacy. The cholesterol-lowering effect of the experimental pasta was also tested
by exposing human hepatocarcinoma cells, which developed lipid storage alterations due to olanzapine (OLZ) exposure, to an extract of the flour mixture used to prepare the experimental pasta.
The participants who consumed the experimental pasta exhibited a significantly greater reduction in serum non-HDL-C levels compared to the control group (
= 0.001). No significant interaction between pasta variety and the TC-PRS on non-HDL-C changes was found. The extract from the experimental flour mixture significantly reduced both the number and size of lipid droplets in HepG2 cells treated with OLZ.
These results indicate that a low-impact lifestyle intervention may offer a practical strategy for improving the cholesterol profile and mitigating cardiovascular risk in patients with MetS, with and without an MPD.
Journal Article
Developing and Evaluating Guidelines to Prevent Overdependence on Digital Therapeutics in Children and Adolescents: Randomized Controlled Trial
Digital therapeutics (DTx) for children and adolescents with mental health problems have been developed in the health care industry. Despite reports of side effects from DTx for children and adolescents, there have been no guidelines to address the prevention of DTx overdependence among young users.
This study aimed to identify the requirements for guidelines to prevent DTx overdependence in children and adolescents and to develop and evaluate these guidelines.
We conducted 2 phases. This study first involved a phase I survey to develop guidelines, including assessments of smartphone usage and mental health conditions. The second phase evaluated the guidelines' effectiveness, reliability, necessity, and satisfaction using a visual analog scale through a randomized controlled trial. Participants-45 children and adolescents aged 9-16 years and 42 caregivers-were randomly assigned to the experimental and control groups.
Phase I revealed that blocking mobile applications and notifications (mean 8.5, SD 1.8) and parental monitoring (mean 8.5, SD 2.1) were effective preventive features. Caregivers, children, and adolescents expressed concerns about the side effects and overdependence of DTx and decreased effects due to nonindividualized guidelines in subjective responses to the phase I survey. Based on these insights, personalized guidelines for phase II were developed, in which overall mean visual analog scale scores for guideline evaluation were higher in the experimental group, except for necessity among caregivers (mean 8.5, SD 1.3 versus mean 8.7, SD 1.2).
Both caregivers and children and adolescents demonstrated the need for guidelines to prevent overdependence on DTx distinct from smartphone usage. Tailored guidelines may be acceptable for use in real-world therapeutic protocols. Guidelines to prevent overdependence on DTx in children and adolescents and to achieve a balance between their benefits and risks need to be established.
Clinical Research Information Service (CRiS) of the Republic of Korea KCT0008893; https://cris.nih.go.kr/cris/search/detailSearch.do?seq=25609.
Journal Article