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The rationale, the study design, and the core features of the study are presented here. It is a phase II randomized, double-blind, active placebo-controlled parallel group trial with 144 patients. Some of these challenges are being addressed in the given clinical trial on the efficacy and safety of psilocybin in treatment-resistant major depression. These include the problem of successful blinding, which can hardly be guaranteed in clinical trials with psychedelic substances and – directly related – the high risk of expectation bias and nocebo effects. However, clinical trials with psychedelic drugs pose particular methodological challenges to researchers, some of which differ considerably from those with other psychotropic drugs. Psychedelics such as psilocybin have recently gained remarkable interest in both the specialist literature and the lay press because studies suggest that these substances may have great therapeutic potential in various psychiatric disorders, including major depression. Detailed psychometric results are displayed elsewhere (). Its usability was rated positively by the interviewers. Used in a depression treatment trial with 260 patients, the German GRID-HAMD showed adequate internal consistency (mean alpha 0.75 - 0.78) and satisfactory criterion validity towards diagnosed major depression (ICD-10 based psychologist interview: mean r = 0.70 - 0.71) and self-report measures of depressive symptoms (PHQ-9: mean r = 0.66 - 0.67 CES-D: mean r = 0.68).

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Its German version was developed in 2012: The English GRID-HAMD system and manual (Bech et al., 2003) were translated into German and adapted by a team of bilingual clinical psychologists the wording was matched to the German version of the original HAMD and the German DSM-IV a scoring sheet was added to the German version. The GRID Hamilton Rating Scale for Depression (GRID-HAMD) is a standardised version of the Hamilton Rating Scale for Depression (HAMD), which was developed by the 'Depression Rating Scale Standardization Team' (Bech P, Engelhardt N, Evans K, Kalali A, Kobak K, Lipsitz J, Olin J, Pearson J, Rothman M & Williams JBW) to facilitate the symptom rating procedure and support higher reliability (inter-rater agreement) of depression measurement using the HAMD interview.

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