Background and Objective Cognitive impairments associated with schizophrenia (CIAS) predict poor functional outcomes, but there are currently no approved pharmacological treatments for patients with CIAS. Additional cognitive stimulation may be required for pro-cognitive medications to improve efficacy, and computerized cognitive training (CCT) can be used to increase cognitive activity. A trial evaluating the effects of the novel glycine transporter inhibitor BI 425809 compared with placebo, on a background of regularly self-administered CCT in clinically stable patients with schizophrenia has commenced and its methodology is described here. Methods This Phase II, multinational, randomized, double-blind, placebo-controlled, parallel-group trial will randomize 200 clinically stable outpatients, aged 18-50 years with established schizophrenia and no other major psychiatric disorder, 1:1 to BI 425809 or placebo once daily for 12 weeks. Following screening, which included a 2-week CCT run-in period, patients sufficiently compliant with CCT (target: ≥ 2 h of CCT per week during CCT run-in) will be randomized. During the 12-week treatment period, all patients should complete a total of approximately 30 h of CCT. The primary endpoint is change from baseline in neurocognitive function as measured by the neurocognitive composite score of the Measurement and Treatment Research to Improve Cognition in Schizophrenia Consensus Cognitive Battery (MCCB), after 12 weeks of treatment. Secondary endpoints include change from baseline in overall MCCB score, Schizophrenia Cognition Rating Scale, Positive and Negative Syndrome Scale, and safety (adverse events [AEs]) and serious AEs. Primary and secondary endpoints will be analyzed using the Restricted Maximum Likelihood-based mixed model for repeated measures. Novel endpoints include the Balloon Effort Task to evaluate patients' motivation and the Virtual Reality Functional Capacity Assessment Tool to assess skills for daily functioning. Discussion This is one of the largest and longest trials to date to combine pharmacological therapy with CCT in patients with schizophrenia and will determine the benefit of combining BI 425809 pharmacotherapy with cognitive stimulation through self-administered CCT. This trial will further evaluate whether improvements in neurocognition translate into improved everyday functioning, whether self-administered CCT can be effectively implemented in a large multinational trial, and the role of motivation in neurocognitive and functional improvements. Trial Registration Registered on Clinicaltrials.gov on March 1, 2019 (NCT03859973).

The purpose of this study was to identify common factors in false allegation adult crimes, by examining the dynamics involved in 30 confirmed false allegation cases. The authors conducted a comprehensive review of these adjudicated cases and then completed a collection instrument to capture offender demographics, offense characteristics, and motive. The results indicated that most false allegation crimes were committed by women (73.3%) and Caucasians (93.3%). Data indicated that more interpersonally violent allegations were primarily motivated by attention/sympathy needs (50.0%), whereas more impersonal offenses involved other motivations such as providing an alibi (16.7%) or profit (13.3%). Offenders tended to be younger, high school graduates with no higher education (43.3%). A total of 23.3% of offenders had a prior criminal history. Male offenders appeared as likely as women to be motivated by attention/sympathy; however, men tended to select more violent, nonsexual offenses (e.g., attempted murder) than women.

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Background There are currently no approved medications for cognition in patients with schizophrenia. BI 425809, a glycine transporter 1 inhibitor, increases glycine in the synaptic cleft and may improve glutamatergic neurotransmission, synaptic neuroplasticity, and cognition. Pharmacotherapies targeting neuroplasticity may require concurrent cognitive stimulation, and often the surroundings of patients with schizophrenia provide only a low level of cognitive demand. At-home computerised cognitive training (CCT) should increase the level of cognitive stimulation for these patients. Combining CCT with pharmacotherapy could therefore improve cognition in patients with schizophrenia. CCT studies are currently limited in scale and are associated with challenges, such as patient compliance. This ongoing study explores whether at-home CCT combined with BI 425809 could improve cognition, as compared with patients on at-home CCT and placebo, in patients with schizophrenia. Here, we provide an initial reflection on the experiences and challenges associated with setting up this large-scale clinical trial, in addition to an update on recruitment trajectories. Methods This is a Phase II, double-blind, placebo-controlled, parallel group trial in patients with schizophrenia on stable antipsychotic therapy, across ~50 centres in 6 countries. Recruitment commenced in June 2019. Patients (aged 18–50 years) must demonstrate compliance with CCT during a 2-week run-in period; this means completing at least 2 hours/week (i.e. 4 hours total during screening). Only CCT-compliant patients are randomised (1:1) to BI 425809 or placebo once daily on top of CCT for 12 weeks. The target duration for at-home CCT is ~30 hours, across 3–5 sessions (2.5 hours total) per week. The primary endpoint is change from baseline in neurocognitive composite score of the Measurement and Treatment Research to Improve Cognition in Schizophrenia Consensus Cognitive Battery after 12 weeks of treatment. Novel exploratory endpoints include the Virtual Reality Functional Capacity Assessment Tool to assess daily functioning and the Balloon Effort Task to assess motivation in cognitive performance and, its association with patients’ willingness to comply with at-home CCT. Results To date, 32 patients have been screened and 11 randomised (21 patients failed screening, primarily due to non-compliance with CCT run-in). The last patient out is planned for December 2020 and results are expected in Q1 2021. Patients randomised so far (n=11; 82% male) have a mean age of 33 years; those who failed screening (n=21; 67% male) have a mean age of 36 years. Mean MCCB total scores for the two groups are 30.9 and 22.3; Positive and Negative Syndrome Scale (PANNS) total scores: 71.3 vs 77.9; and PANNS negative symptom scores: 20.5 vs 20.3, for the randomised and screen failure patients, respectively. Discussion It is expected that the results of this trial will help to: indicate if there is an enhanced benefit of combining pharmacotherapy with cognitive stimulation through at-home CCT; and determine the role of motivation in CCT compliance and performance in patients with schizophrenia. The main reason for screen failures was non-compliance with CCT run-in, underscoring the relevance of coaching and motivational accompaniment to promote adherence to CCT. The results will indicate if large-scale implementation of at-home CCT across multiple centres and several countries is feasible.