Although some animal research suggests possible sex differences in response to THC exposure (e.g., Cooper & Craft, 2018), there are limited human studies. One study found that among individuals rarely using cannabis, when given similar amounts of oral and vaporized THC females report greater subjective intoxication compared to males (Sholler et al., 2020). However, in a study of daily users, females reported indistinguishable levels of intoxication compared to males after smoking similar amounts (Cooper & Haney, 2014), while males and females using 1–4x/week showed similar levels of intoxication, despite females having lower blood THC and metabolite concentrations (Matheson et al., 2020). It is important to elucidate sex differences in biological indicators of cannabis intoxication given potential driving/workplace implications as states increasingly legalize use. The current study examined if when closely matching males and females on cannabis use variables there are predictable sex differences in residual whole blood THC and metabolite concentrations, and THC/metabolites, subjective appraisals of intoxication, and driving performance following acute cannabis consumption.

The current study was part of a randomized clinical trial (Marcotte et al., 2022). Participants smoked ad libitum THC cigarettes and then completed driving simulations, blood draws, and subjective measures of intoxication. The main outcomes were the change in Composite Drive Score (CDS; global measure of driving performance) from baseline, whole blood THC, 11-OH-THC, and THC-COOH levels (ng/mL), and subjective ratings of how “high” participants felt (0 = not at all, 100 = extremely). For this analysis of participants receiving active THC, males were matched to females on 1) estimated THC exposure (g) in the last 6 months (24M, 24F) or 2) whole blood THC concentrations immediately post-smoking (23M, 23F).

When matched on THC exposure in the past 6 months (overall mean of 46 grams; p = .99), there were no sex differences in any cannabinoid/metabolite concentrations at baseline (all p > .83) or after cannabis administration (all p > .72). Nor were there differences in the change in CDS from pre-to-post-smoking (p = .26) or subjective “highness” ratings (p = .53). When matched on whole blood THC concentrations immediately after smoking (mean of 34 ng/mL for both sexes, p = .99), no differences were found in CDS change from pre-to-post smoking (p = .81), THC metabolite concentrations (all p > .25), or subjective “highness” ratings (p = .56). For both analyses, males and females did not differ in BMI (both p > .7).

When male/female cannabis users are well-matched on use history, we find no significant differences in cannabinoid concentrations following a mean of 5 days of abstinence, suggesting that there are no clear biological differences in carryover residual effects. We also find no significant sex differences following ad libitum smoking in driving performance, subjective ratings of “highness,” nor whole blood THC and metabolite concentrations, indicating that there are no biological differences in acute response to THC. This improves upon previous research by closely matching participants over a wider range of use intensity variables, although the small sample size precludes definitive conclusions.

A new mental health service specialising in intellectual disabilities in Ireland was set up in January 2022. Its current compliment of staff includes is a Consultant Psychiatrist, Trainee Psychiatrist, Social Worker and Administrator. The current National Directive in Ireland is to prioritize Mental Health of Intellectual Disabilities services.

The aim of the project is to establish the current baseline level of diagnostics and interventions within the new service. Our aim is to develop this service by implementing and following the gold standard guidelines and determine what extra resources does the service need.

The first fifty case notes of patients assessed by the new service were inspected. The reviewer looked for evidence of the following clinical descriptions:Diagnosis of Intellectual Disabilities and its severity; Mental Capacity; Psychiatric Diagnoses; Physical health diagnoses; Medications and evidence of a Positive Behavioural Support Plan to manage complex challenging behaviours.

The fifty patient audit contained 38 (76%) men and 12 (24% women) . One patient had Mild Intellectual Disabilities (ID), 39 (78%) had Moderate ID and 10 (20%) had Severe ID. All patents were very vulnerable and had limited or lacking Mental Capacity. Common diagnoses of the following were recorded in the following numbers and percentages; - Autism diagnosis 30 ( 60% ); Epilepsy 19 (38%); & Down Syndrome 9 (18%). A Formal Psychiatric diagnosis was identified in 26 (52%) of patients. Challenging Behaviour (severe and complex) was identified for 41 ( 82%) of the patients. The full breakdown of psychiatric diagnoses was ‘Psychotic illness’ – 9 (18%); Anxiety – 7(14%); Bipolar Affective Disorder 5 (10%): Depression – 4(8%); Attention Deficit Hyperactivity Disorder (ADHD) 3 (6%); Obsessive Compulsive Disorder (OCD) – 2(4%); Dementia – 2(4%): Post Traumatic Stress Disorder (PTSD) – 1 (2%); & Schizoaffective Disorder 1(2%). A Positive Behavioural Support plan (PBS) was available to support 33 (66%) of patients.

42 (84%) of patients were prescribed antipsychotic medication. 12 (24%) were prescribed more than one antipsychotic. 20 (40%) were prescribed an antipsychotic without a formally documented diagnosis of a psychotic disorder. 12 (24%).

The results of this first survey highlight areas in which the service can be improved. The service has requested funding for a Community Nurse and a Psychologist. Psychological evaluations and Positive Behavioural Support plans are essential for people with complex challenging behaviours. A Community Nurse should assist with Health Promotion and help supervise patients requiring Depot Antipsychotic medication or Clozapine. We also plan to set up a joint clinic with the Consultant Neurologist on a regular basis.

None Declared

Prior trials suggest that intravenous racemic ketamine is a highly effective for treatment-resistant depression (TRD), but phase 3 trials of racemic ketamine are needed.

To assess the acute efficacy and safety of a 4-week course of subcutaneous racemic ketamine in participants with TRD. Trial registration: ACTRN12616001096448 at www.anzctr.org.au.

This phase 3, double-blind, randomised, active-controlled multicentre trial was conducted at seven mood disorders centres in Australia and New Zealand. Participants received twice-weekly subcutaneous racemic ketamine or midazolam for 4 weeks. Initially, the trial tested fixed-dose ketamine 0.5 mg/kg versus midazolam 0.025 mg/kg (cohort 1). Dosing was revised, after a Data Safety Monitoring Board recommendation, to flexible-dose ketamine 0.5–0.9 mg/kg or midazolam 0.025–0.045 mg/kg, with response-guided dosing increments (cohort 2). The primary outcome was remission (Montgomery-Åsberg Rating Scale for Depression score ≤10) at the end of week 4.

The final analysis (those who received at least one treatment) comprised 68 in cohort 1 (fixed-dose), 106 in cohort 2 (flexible-dose). Ketamine was more efficacious than midazolam in cohort 2 (remission rate 19.6% v. 2.0%; OR = 12.1, 95% CI 2.1–69.2, P = 0.005), but not different in cohort 1 (remission rate 6.3% v. 8.8%; OR = 1.3, 95% CI 0.2–8.2, P = 0.76). Ketamine was well tolerated. Acute adverse effects (psychotomimetic, blood pressure increases) resolved within 2 h.

Adequately dosed subcutaneous racemic ketamine was efficacious and safe in treating TRD over a 4-week treatment period. The subcutaneous route is practical and feasible.

Perinatal substance abuse (PSA) is associated with increased risk of prematurity, low birth weight, neonatal abstinence syndrome, behavioral issues and learning difficulties. It is imperative that robust care pathways are in place for these high-risk pregnancies and that staff and patient education are optimized. The present study explores the knowledge and attitudes of healthcare professionals toward PSA to identify knowledge gaps to enhance care and reduce stigma.

This is a cross-sectional study using questionnaires to survey healthcare professionals (HCPs) working in a tertiary maternity unit (n = 172).

The majority of HCPs were not confident in the antenatal management (75.6%, n = 130) or postnatal management (67.5%, n = 116) of PSA. More than half of HCPs surveyed (53.5%, n = 92) did not know the referral pathway and 32% (n = 55) did not know when to make a TUSLA referral. The vast majority (96.5%, n = 166) felt that they would benefit from further training, and 94.8% (n = 163) agreed or strongly agreed that the unit would benefit from a drug liaison midwife. Among study participants, 54.1% (n = 93) agreed or strongly agreed that PSA should be considered a form of child abuse and 58.7% (n = 101) believe that the mother is responsible for damage done to her child.

Our study highlights the urgent need for increased training on PSA to enhance care and reduce stigma. It is imperative that staff training, drug liaison midwives and dedicated clinics are introduced to hospitals as a matter of high priority.

Obsessive–compulsive disorder (OCD) is a psychiatric condition leading to significant distress and poor quality of life. Successful treatment of OCD is restricted by the limited knowledge about its pathophysiology. This study aimed to investigate the pathophysiology of OCD using electroencephalographic (EEG) event-related potentials (ERPs), elicited from multiple tasks to characterise disorder-related differences in underlying brain activity across multiple neural processes.

ERP data were obtained from 25 OCD patients and 27 age- and sex-matched healthy controls (HCs) by recording EEG during flanker and go/nogo tasks. Error-related negativity (ERN) was elicited by the flanker task, while N200 and P300 were generated using the go/nogo task. Primary comparisons of the neural response amplitudes and the topographical distribution of neural activity were conducted using scalp field differences across all time points and electrodes.

Compared to HCs, the OCD group showed altered ERP distributions. Contrasting with the previous literature on ERN and N200 topographies in OCD where fronto-central negative voltages were reported, we detected positive voltages. Additionally, the P300 was found to be less negative in the frontal regions. None of these ERP findings were associated with OCD symptom severity.

These results indicate that individuals with OCD show altered frontal neural activity across multiple executive function-related processes, supporting the frontal dysfunction theory of OCD. Furthermore, due to the lack of association between altered ERPs and OCD symptom severity, they may be considered potential candidate endophenotypes for OCD.

Idiopathic subglottic stenosis describes subglottic stenosis where no inflammatory, traumatic, iatrogenic or other causative aetiology can be identified. The present study aimed to outline our institution's experience of patients diagnosed with idiopathic subglottic stenosis and describe a very rarely reported familial association.

A retrospective review was conducted of prospectively maintained medical records from 2011 to 2020. Patient clinical, radiological and intra-operative data were reviewed to assess for defined endpoints.

Ten patients with idiopathic subglottic stenosis were identified in this series. One familial pairing was identified, with two sisters presenting with the condition. Successful treatment with carbon dioxide laser and dilatation was achieved in most cases.

Idiopathic subglottic stenosis represents a rare, clinically challenging pathology. Management with endoscopic laser and balloon dilatation is an effective treatment. This paper highlights a very rare familial association, and describes our experience in treating idiopathic subglottic stenosis.

The purpose of this study was to pilot safety and tolerability of a 1-week aerobic exercise program during the post-acute phase of concussion (14–25 days post-injury) by examining adherence, symptom response, and key functional outcomes (e.g., cognition, mood, sleep, postural stability, and neurocognitive performance) in young adults.

A randomized, non-blinded pilot clinical trial was performed to compare the effects of aerobic versus non-aerobic exercise (placebo) in concussion patients. The study enrolled three groups: 1) patients with concussion/mild traumatic brain injury (mTBI) randomized to an aerobic exercise intervention performed daily for 1-week, 2) patients with concussion/mTBI randomized to a non-aerobic (stretching and calisthenics) exercise program performed daily for 1-week, and 3) non-injured, no intervention reference group.

Mixed-model analysis of variance results indicated a significant decrease in symptom severity scores from pre- to post-intervention (mean difference = −7.44, 95% CI [−12.37, −2.20]) for both concussion groups. However, the pre- to post-change was not different between groups. Secondary outcomes all showed improvements by post-intervention, but no differences in trajectory between the groups. By three months post-injury, all outcomes in the concussion groups were within ranges of the non-injured reference group.

Results from this study indicate that the feasibility and tolerability of administering aerobic exercise via stationary cycling in the post-acute time frame following post-concussion (14–25 days) period are tentatively favorable. Aerobic exercise does not appear to negatively impact recovery trajectories of neurobehavioral outcomes; however, tolerability may be poorer for patients with high symptom burden.

Patient preferences in schizophrenia (SCZ), including identification of key goals and outcomes for treatment and relative importance of certain treatment goals to patients, have been assessed by several studies. However, there continues to be a lack of sufficient evidence on US patient attitudes and perceptions towards treatment goals and pharmacotherapy options in SCZ, especially taking into context long-acting injectable antipsychotics (LAIs) in this disease area. This lack of evidence is further pronounced in caregivers of individuals with SCZ. The objective of this analysis was to characterize patients with SCZ on LAIs vs patients on oral antipsychotics (OAPs) and evaluate the treatment goals of patients in each group.

This was a real-world, cross-sectional survey of US psychiatrists, patients =18 years old with a diagnosis of SCZ, and caregivers. Data was collected using the Disease Specific Programme (DSP) methodology, which has been previously published. Psychiatrists (n=120) completed detailed record forms for next 8 consecutive outpatients and 2 inpatients matching inclusion criteria, including non-interventional clinical and subjective assessments. The same patients and their caregivers, if present, were invited by their psychiatrist to voluntarily complete a separate survey.

Of 1135 patients on treatment where the physician provided survey data; 251 were on an LAI, and 884 were on an OAP. Mean (SD) time to SCZ diagnosis for those on an LAI was 10.3 (12.0) years vs 7.8 (10.5) years for those on OAPs. More patients in the LAI vs OAP group were being treated as an inpatient (27.1% vs 15.7%, respectively; p<0.0001). Patients on an LAI reported being on their current medication regimen for less time (mean 1.7 years) vs those on OAPs (mean 2.5 years) (p=0.0093). More patients on LAIs were unemployed due to disability vs those on OAPs (56.1% vs 39.5%, respectively), and less patients on LAIs were able to work part-time or full-time (21.1% or 4.1%) vs those on OAPs (23.2% or 11.4%). More patients on an LAI had a caregiver vs those on OAPs (37.3% vs 26.1%, respectively; p=0.0011). Regarding the most important treatment goals reported by patients, both groups reported similar preferences for decrease in disease symptoms (62% on LAI vs 65% on OAPs) and thinking more clearly (53% on LAI vs 46% on OAPs); however, a numerically higher proportion of LAI patients reported that the current medication helped decrease hospitalizations due to relapse vs those on OAPs (38% vs 32%, respectively).

Given the characteristics of patients participating in this real-world survey, those on LAIs exhibited qualities which indicate a higher severity of illness vs those on OAPs. Results suggest that treatment with LAIs is still mainly being provided to patients later in the disease course and/or who have adherence problems, despite a growing body of evidence of utility in younger patients earlier in the course of illness.

Otsuka Pharmaceutical Development & Commercialization, Inc. and Lundbeck LLC

Objectives for this survey are to determine similarities or differences in treatment goals reported by psychiatrists, patients with schizophrenia (SCZ) and caregivers in the US, as well as whether goals differed by patients currently on an oral antipsychotic (OAP) or long-acting injectable (LAI), and whether goals differed by age.

This was a real-world, cross-sectional survey of US psychiatrists, patients =18 years old diagnosed with SCZ, and caregivers. Data was collected using the Disease Specific Programme (DSP) methodology. Psychiatrists (n=120) completed detailed record forms for next 8 outpatients and 2 inpatients matching inclusion criteria. The same patients and their caregivers, if present, were invited by their psychiatrist to voluntarily complete a separate survey.

Responses on treatment goals were collected from psychiatrists for all patients included in the analysis (n=1161), patients (n= 542) and caregivers (n=130). Among 3 top goals, psychiatrists, patients and caregivers concurred that “decrease in disease symptoms” is most important (63%, 64%, 68% respectively). For psychiatrists and caregivers, second was “decrease in hospitalization for relapse” (41%, and 38% respectively), whereas for patients, it was “thinking clearly” (47%). Of the 3 least important goals, psychiatrists, patients and caregivers agreed with “sexual problems” (59%, 43%, 44%, respectively) and “weight gain” (38%, 44%, 38%, respectively).

When asked which goals were met by current medication, patients responded “decrease in disease symptoms” (68%) and “thinking clearly” (39%). However, caregivers responded “thinking clearly” (30%) was not met by current medication. Caregivers most important goals, “decrease in disease symptom” (70%) and “decrease in hospitalization for relapse” (41%), were met. Additional analyses of patients on OAPs and LAIs, did not show differences in goals. However, “decrease in disease symptoms” was numerically more important for patients on LAIs vs OAPs according to psychiatrists (68% vs 62%) and caregivers (77% vs 70% respectively). Caregivers responded “decrease in hospitalization for relapse” was met for 63% patients currently on an LAI and 35% OAP. No major differences in treatment goals were observed by patient age (18–35 vs 36–65 vs >65 years).

There is consensus among US psychiatrists, patients and caregivers on the most important treatment goal “decrease in disease symptoms”, regardless of patients’ current medication or age. For patients, “thinking more clearly” was second, compared with “decrease in hospitalization due to relapse”, for psychiatrists and caregivers. All agreed that least important treatment goals, related to AEs, were “weight gain” and “sexual problems”. More caregivers agreed “decrease in hospitalization for relapse” was met by patients on LAIs vs OAPs. These findings may help with discussions between psychiatrists, patients and caregivers.

Lundbeck LLC and Otsuka Pharmaceutical Development & Commercialization, Inc.