Expert consensus recommendations on the use of randomized clinical trials for drug approval in psychiatry- comparing trial designs.

The use of randomized clinical trials, in particular placebo-controlled trials, for drug approval, is the subject of long-standing debate in the scientific community and beyond. This study offers consensus recommendations from clinical and academic experts to guide the selection of clinical trial design in psychiatry. Forty-one highly cited clinical psychiatrists and/or researchers participated in a Delphi survey. Consensus statements were developed based on the findings of a published, peer-reviewed systematic review. Participants evaluated statements in two survey rounds, following the Delphi method. The expert panel achieved consensus on 7 of 21 recommendations regarding the use of randomized clinical trials. The endorsed recommendations were: (i) Results from placebo-controlled trials are the most reliable and (ii) are necessary despite the growing placebo-effect; (iii) it is ethical to enroll patients in placebo-arms when established treatment is available, if there is no evidence of increased health risk; (iv) There is a need to approve new drugs with the same efficacy as existing treatments, but with different side-effect profiles; (v) Non-inferiority trials incur an increased risk of approving ineffective medications; (vi) The risk of approving an ineffective drug justifies trial designs that incur higher costs, and (vii) superiority trials incur the risk of rejecting potentially efficacious treatments. The endorsed recommendations inform the choice of trial-design appropriate for approval of psychopharmacological drugs. The recommendations strongly support the use of randomized clinical trials in general, and the use of placebo-controlled trials in particular.

Shared Living Experiences by Physicians have a Positive Impact on Mental Health Attitudes and Stigma among Medical Students: A Mixed-Methods Study.

INTRODUCTION: Medical culture can make trainees feel like there is neither room for mistakes, nor space for personal shortcomings in the makeup of physicians. A dearth of role models who can exemplify that it is acceptable to need support compounds barriers to help-seeking once students struggle. We conducted a mixed-methods study to assess the impact of physicians sharing their living experiences with medical students. METHODS: Second-year medical students participated, through synchronized videoconferencing, in an intervention consisting of 3 physicians who shared personal histories of vulnerability (e.g. failure on high-stakes exams; immigration and acculturation stress; and personal psychopathology, including treatment and recovery), followed by facilitated, small-group discussions. For the quantitative component, students completed the Opening Minds to Stigma Scale for Health Care Providers (OMS-HC) before and after the intervention. For the qualitative component, we conducted focus groups to explore the study intervention. We analyzed anonymized transcripts using thematic analysis aided by NVivo software. RESULTS: We invited all students in the class (n = 61, 46% women) to participate in the research component. Among the 53 participants (87% of the class), OMS-HC scores improved after the intervention (P = .002), driven by the Attitudes (P = .003) and Disclosure (P < .001) subscales. We conducted 4 focus groups, each with a median of 6 participants (range, 5-7). We identified, through iterative thematic analysis of focus group transcripts, active components before, during, and after the intervention, with unexpected vulnerability and unarmored mutuality as particularly salient. CONCLUSIONS: Sharing histories of personal vulnerability by senior physicians can lessen stigmatized views of mental health and normalize help-seeking among medical students. Synchronous videoconferencing proved to be an effective delivery mechanism for the intervention in a 'virtual wellness' format. Candid sharing by physicians has the potential to enhance students' ability to recognize, address, and seek help for their own mental health needs.

Time perception and impulsivity: A proposed relationship in addictive disorders.

Addictive disorders are characterized by impulsive behavior that leads to difficulties in preventing certain behaviors despite negative consequences. This symptom predisposes to a vulnerability in developing addictive disorders and is also aggravated by the addiction process itself. As such, understanding the underlying mechanisms of impulsivity is a challenge for understanding the pathophysiology of addiction. One common link between impulsivity and addiction is that both involve actions and decisions that are realized faster than they should be in time. Impulsive traits increase the tendency to choose immediate gratification instead of delayed gratification even when preferred. This observation suggests a relationship between impulsivity and time processing. To better understand this relationship, we reviewed the literature that describes the relationship between time processing and impulsivity in addictive disorders in humans. Despite a lack of literature concerning this question in alcohol, cannabis and gambling disorders, we highlight that addictive behaviors are a good model for understanding the pathophysiology of impulsivity, and could help us to better understand the relationship between time perception and impulsivity.

Cognitive effects of labeled addictolytic medications.

INTRODUCTION: Alcohol, tobacco, and illegal drug usage is pervasive throughout the world, and abuse of these substances is a major contributor to the global disease burden. Many pharmacotherapies have been developed over the last 50years to target addictive disorders. While the efficacy of these pharmacotherapies is largely recognized, their cognitive impact is less known. However, all substance abuse disorders are known to promote cognitive disorders like executive dysfunction and memory impairment. These impairments are critical for the maintenance of addictive behaviors and impede cognitive behavioral therapies that are regularly administered in association with pharmacotherapies. It is also unknown if addictolytic medications have an impact on preexisting cognitive disorders, and if this impact is modulated by the indication of prescription, i.e. abstinence, reduction or substitution, or by the specific action of the medication. METHOD: We reviewed the cognitive effects of labeled medications for tobacco addiction (varenicline, bupropion, nicotine patch and nicotine gums), alcohol addiction (naltrexone, nalmefene, baclofen, disulfiram, sodium oxybate, acamprosate), and opioid addiction (methadone, buprenorphine) in human studies. Studies were selected following MOOSE guidelines for systematic reviews of observational studies, using the keywords [Cognition] and [Cognitive disorders] and [treatment] for each medication. RESULTS: 971 articles were screened and 77 studies met the inclusion criteria and were reported in this review (for alcohol abuse, n=21, for tobacco n=22, for opioid n=34. However, very few comparative clinical trials have explored the chronic effects of addictolytic medications on cognition in addictive behaviors, and there are no clinical trials on the cognitive impact of nalmefene in patients suffering from alcohol use disorders. DISCUSSION: Although some medications seem to enhance cognition in patients suffering from cognitive disorders, others could promote cognitive impairments, and our work highlights a lack of literature on this subject. In conclusion, more comparative clinical trials are needed to better understand the cognitive impact of addictolytic medications.