Introduction: This report describes difficulties encountered when attempting to recruit children and adolescents with major depression for a recent international double-blind, placebo-controlled trial (www.clinicaltrials.gov Nr. NCT00849901). Methods: Over a 14-month period, children and adolescents with depressive symptoms were pre-screened for their eligibility for inclusion. Results: 85 patients (age 7?17 years) were considered. Of these, only one was enrolled. The main reasons for non-eligibility were: failure to meet the baseline severity criterion on the primary outcome scale (Clinical Global Impression ? Severity; 32.1% of the patients); requirement for immediate hospitalisation (15.4%); or the presence of an exclusionary comorbid psychiatric disorder (19.1%). Discussion: The recruitment of paediatric patients with major depression was primarily limited by various inclusion and exclusion criteria. Slow recruitment of small patient samples may impact strongly on the representativeness and generalisability of research findings, and thus on analyses in evidence-based medicine and on the development and recommendations of treatment guidelines. This may impact in turn on the feasibility of the clinical development and registration process of new compounds in paediatric psychopharmacology and beyond.

This article discusses general issues with regard to gender-identity problems, sex reassignment, and clinical management in patients with ambiguous genitalia, based on a detailed case history of a patient with penile agenesis who has been followed more than 20 years. After initial uncertainty, the patient began to grow up as a boy, lived from the fourth year of life as a girl and young woman, and lived from late puberty on as a man. Over his lifetime he experienced extensive corrective surgery plus hormonal substitution therapy. Pre- and perinatal hormonal conditions, phenomenology of the genitalia, sex of rearing, timing of sex reassignment and corrective surgery, for example, appear to be important components for the development of gender-role behavior, gender identity, and sexual orientation of intersex patients. Findings and retrospective considerations for this patient suggest the need for careful differential activities in diagnostic workup, approaches to sex assignment and possible reassignment, and the clinical management of patients and families.

Between 1990 and 1993, a series of drug utilization observation studies with fluoxetine (Flx) were conducted in Germany in several waves. 3,158 patients treated by psychiatrists/neurologists (PN) and 15,601 patients treated by general practitioners/internists (GPI) were included; data collection at start and end of treatment focussed on diagnoses, symptoms, prescription, comedication, efficacy (CGI, Zung scale), and adverse events. Differences between PN and GPI patients were of major interest. For more than 90% of both the PN and the GPI cases. Fix was used for the indication of "depression", with a dosis of 20 mg/day. More PN patients (47%) than GPI patients (28%) were diagnosed as "endogenous"; GPI patients more often presented with first episodes (36 vs. 24%). "suicidal ideation" was less prominent compared to PN subjects (17 vs. 28%). Psychotropic comedication was regarded as necessary in 39% (PN) and 10% (GPI) of the cases. Early treatment termination because of "remission/major improvement" was observed in 13% (PN) vs. 21% (GPI) and because of "adverse events" in 11% (PN) vs. 3% (GPI) of the patients. At observation end, 53% (PN) vs. 74% (GPI) were rated as "symptom-free/markedly improved" (CGI); self-ratings reflected comparable results, marked improvements over time, but still PN/GPI differences at the end. "Suicidality" related to depression was more pronounced in the PN group at both points in time. 24% (PN) vs. 6% (GPI) of the cases reported "routine" adverse events, while in 2% (PN) and 1% (GPI) "serious" adverse events were observed. (For all the above comparisons p < 0.001 to < 0.0001.) These findings reveal that-under routine conditions handled by PNs and GPIs-Fix shows an efficacy and safety consistent with clinical trial data. The body of data suggests that PN patients present with more severe depression and more suicidality, require more comedication, and end up with a poorer outcome. Differences in the physicians' perception of psychiatric and somatic symptomatology and their treatment routines may also have something to do with the PN/GPI group differences observed.