Clinical trial designs of new medicinal products for treating schizophrenia: discussion of EMA's Guideline and a Better Long Term Trial Design

Background and Objectives: Schizophrenia is a severe chronic disease. Endpoint variables lack objectivity and the diagnostic criteria have evolved with time. In order to guide the development of new drugs, European Medicines Agency (EMA) issued a guideline on the clinical investigation of medicinal products for the treatment of schizophrenia. Methods: Authors reviewed and discussed the efficacy trial part of the Guideline. Results: The Guideline divides clinical efficacy trials into short-term trials and long-term trials. The short-term three-arm trial is recommended to replace the short-term two-arm active-controlled non-inferiority trial because the latter has sensitivity issues. The Guideline ultimately makes that three-arm trial a superiority trial. The Guideline discusses four types of long-term trial designs. The randomized withdrawal trial design has some disadvantages. Long-term two-arm active-controlled non-inferiority trial is not recommended due to the sensitivity issue. Extension of the short-term trial is only suitable for extension of the short-term two-arm active-controlled superiority trial. The Guideline suggests that a hybrid design of a randomized withdrawal trial incorporated into a long-term parallel trial might be optimal. However, such a design has some disadvantages and might be too complex to be carried out. Authors suggest instead a three-group long-term trial design, which could provide comparison between test drug and active comparator along with comparison between the test drug and placebo. This alternative could arguably be much easier to carry out compared with the hybrid design. Conclusions: The three-group long-term design merits further discussion and evaluation.

Cognitive-behavioral group therapy for girls victims of sexual violence in Brazil: Are there differences in effectiveness when applied by different groups of psychologists?: effectiveness of group therapy for girls victims of sexual violence

The effectiveness of a cognitive-behavioral group therapy model for the treatment of girls victims of sexual violence (SV) was investigated when applied by different groups of practitioners: researchers/psychologists who developed it (G1) and psychologists from the public social care network trained by the first group (G2). A quasi-experimental study was carried out, in which the group therapy model was applied by the two groups. A total of 103 girls victims of sexual violence (SV), aged between seven and 16 years (M=11.76 years, SD=2.02 years) were included, with 49 attended by G1, and 54 by G2. The results indicated a significant reduction in the symptoms of depression, anxiety, stress, and PTSD. The comparison between the results obtained by the two groups of practitioners in the application of the model indicated no significant differences in the rates of improvement of the participants. These results indicate the effectiveness of the cognitive-behavioral group therapy model evaluated and the possibility of it being used as a care strategy by psychology practitioners working in public services.