Post-traumatic stress disorder (PTSD) presents a major public health problem for which currently available treatments are modestly effective. We report the findings of a randomized, double-blind, placebo-controlled, multi-site phase 3 clinical trial (NCT03537014) to test the efficacy and safety of 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy for the treatment of patients with severe PTSD, including those with common comorbidities such as dissociation, depression, a history of alcohol and substance use disorders, and childhood trauma. After psychiatric medication washout, participants (n = 90) were randomized 1:1 to receive manualized therapy with MDMA or with placebo, combined with three preparatory and nine integrative therapy sessions. PTSD symptoms, measured with the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5, the primary endpoint), and functional impairment, measured with the Sheehan Disability Scale (SDS, the secondary endpoint) were assessed at baseline and at 2 months after the last experimental session. Adverse events and suicidality were tracked throughout the study. MDMA was found to induce significant and robust attenuation in CAPS-5 score compared with placebo (P < 0.0001, d = 0.91) and to significantly decrease the SDS total score (P = 0.0116, d = 0.43). The mean change in CAPS-5 scores in participants completing treatment was −24.4 (s.d. 11.6) in the MDMA group and −13.9 (s.d. 11.5) in the placebo group. MDMA did not induce adverse events of abuse potential, suicidality or QT prolongation. These data indicate that, compared with manualized therapy with inactive placebo, MDMA-assisted therapy is highly efficacious in individuals with severe PTSD, and treatment is safe and well-tolerated, even in those with comorbidities. We conclude that MDMA-assisted therapy represents a potential breakthrough treatment that merits expedited clinical evaluation.

This study tested the efficacy of a new social skills intervention, S ocial S kills GR oup IN tervention-High Functioning Autism (S.S.GRIN-HFA), designed to improve social behaviors in children with high functioning autism spectrum disorders. Fifty-five children were randomly assigned to S.S.GRIN-HFA treatment (n = 27) or control (i.e., traditional S.S.GRIN intervention; n = 28). Examination of the direction and magnitude of change in functioning revealed that children who participated in S.S.GRIN-HFA exhibited significantly greater mastery of social skill concepts compared to children in the control group. Parents of S.S.GRIN-HFA group participants reported an improved sense of social self-efficacy, whereas parents of control participants reported a decline. The advantages of a specialized intervention such as S.S.GRIN-HFA, designed specifically for children with high functioning autism spectrum disorders, are discussed.

Background SARS-CoV-2 infection in Healthcare Workers (HCWs) is a public health concern during the pandemic. Little description has been made of their antibody response over time in the presence or absence detectable SARS-CoV-2 RNA and of symptoms. We followed a cohort of patient-facing HCWs at an acute hospital in London to measure seroconversion and RNA detection at the peak of the pandemic in London. Methods We enrolled 200 front-line HCWs between 26 March and 8 April 2020 and collected twice-weekly self-administered nose and throat swabs and monthly blood samples. Baseline and regular symptom data were also collected. Swabs were tested for SARS-CoV-2 RNA by polymerase chain reaction, and serum for IgM, IgA and IgG antibodies to the virus spike protein by enzyme-linked immunosorbent assay and flow cytometry. Findings We enrolled HCWs with a variety of roles who worked in areas where COVID-19 patients were admitted and cared for. During the first month of observation, 42/200 (21%) HCWs were PCR positive in at least one nose and throat swab. Only 8/42 HCW (19%) who were PCR positive during the study period had symptoms that met the current case definition. Of 181 HCWs who provided enrollment and follow-up blood samples, 82/181 (45.3%) were seropositive; 36/181 (19.9%) seroconverted during the study and 46/181 (25.4%) were seropositive at both time points. In 33 HCWs who had positive serology at baseline but were PCR negative, 32 remained PCR negative throughout follow-up. One HCW had a PCR positive swab six days after enrollment, likely representing a waning infection. Interpretation The extremely high seropositivity and RNA detection in this cohort of front-line HCWs who worked during the peak of the pandemic brings policies to protect staff and patients in the hospital environment into acute focus. Our findings have implications for planning for the expected second wave and for future vaccination roll out campaigns in similar settings. The further evidence of asymptomatic SARS-CoV-2 infection indicates that asymptomatic surveillance of HCWs is essential while our study sets the foundations to answer pertinent questions around the duration of protective immune response and the risk of re-infection.

SummaryProblems of sexual function and fertility in long-term survivors (≥5 years) of haematological malignancy are often neglected in clinic. Our centre carried out a questionnaire study in this population addressing patientperceived fertility and sexual function. 718 patients responded (56% of those invited; 39% Hodgkin, 45% non-Hodgkin lymphoma, 16% acute leukaemia). Respondent women were more likely to remain childless than a normal control population. Self-reported infertility was more likely in men than women [odds ratio (OR) 1Á77, P = 0Á001]. Myeloablative therapy increased the likelihood of childlessness (OR 2Á48, P = 0Á004). Few attended fertility support services (12%). 24% of men banked sperm and 29% of these used the sample, of which 46% resulted in successful pregnancy. Fertility clinic attendance and sperm storage was more likely post-1990 (OR 4Á05, P < 0Á001; OR 5Á05, P < 0Á001 respectively). Reporting a negative impact of cancer on sexual function was more common in women than men (OR 2Á20, P < 0Á001), and increased with current age and age at diagnosis (by 3-4% per year, P ≤ 0Á001) but decreased with longer followup (by 2%/year, P = 0Á005). Patients on anti-depressants and those reporting cancer-related body change/appearance concerns more frequently reported a negative impact (P < 0Á04 and P < 0Á03 respectively). These self-reported outcomes confirm literature findings, suggest improvement over time, but highlight a need for involvement of support services.

Importance There is a pressing need for development of novel pharmacology for the treatment of Posttraumatic Stress Disorder (PTSD). Given increasing use of medical cannabis among US military veterans to self-treat PTSD, there is strong public interest in whether cannabis may be a safe and effective treatment for PTSD. Objective The aim of the present study was to collect preliminary data on the safety and potential efficacy of three active concentrations of smoked cannabis (i.e., High THC = approximately 12% THC and < 0.05% CBD; High CBD = 11% CBD and 0.50% THC; THC+CBD = approximately 7.9% THC and 8.1% CBD, and placebo = < 0.03% THC and < 0.01% CBD) compared to placebo in the treatment of PTSD among military veterans. Methods The study used a double-blind, cross-over design, where participants were randomly assigned to receive three weeks of either active treatment or placebo in Stage 1 (N = 80), and then were re-randomized after a 2-week washout period to receive one of the other three active treatments in Stage 2 (N = 74). The primary outcome measure was change in PTSD symptom severity from baseline to end of treatment in Stage 1. Results The study did not find a significant difference in change in PTSD symptom severity between the active cannabis concentrations and placebo by the end of Stage 1. All three active concentrations of smoked cannabis were generally well tolerated. Conclusions and relevance The present study is the first randomized placebo-controlled trial of smoked cannabis for PTSD. All treatment groups, including placebo, showed good tolerability and significant improvements in PTSD symptoms during three weeks of treatment, but no active treatment statistically outperformed placebo in this brief, preliminary trial. Additional well-controlled and adequately powered studies with cannabis suitable for FDA drug development are needed to determine whether smoked cannabis improves symptoms of PTSD. Trial registration Identifier: NCT02759185; ClinicalTrials.gov.