Combining an SSRI with an anticonvulsant in depressed patients with dysphoric mood: an open study

BACKGROUND: Several patients with unipolar depression present with prominent dysphoric mood. We aimed at examining the effectiveness of the combination of an SSRI with an anticonvulsant in such patients. METHODS: Thirty-five newly admitted outpatients with substantial anger, irritability, aggressiveness or hostility who were diagnosed a DSM-IV unipolar depressive disorder were rated on the Hamilton Depression Rating Scale (HDRS), the Clinical Global Improvement (CGI) scale, and a scale for the rapid dimensional assessment (SVARAD), were prescribed an SSRI and an anticonvulsant (usually valproate), and were followed up for 12 weeks. Repeated measures analysis of variance was used to test for within-subject changes in scale scores over time. RESULTS: Thirty-two and 23 patients attended the follow-up visits 4 and 12 weeks later, respectively. Significant decreases (p < .001) were observed in HDRS total score, HDRS and SVARAD anxiety factors, HDRS and SVARAD core depression factors, and SVARAD anger/irritability factor. Adjusting for age or gender did not change the results. Most patients (82%) were rated as improved or much improved on the CGI. CONCLUSION: Although our study has several limitations, we observed a remarkable improvement in most unipolar depressed outpatients with dysphoric mood treated with an SSRI and an anticonvulsant. The effectiveness of anticonvulsants might be linked to their action on symptoms of aggression and behavioural activation

An international study of middle school students’ preferences about digital interactive education activities for promoting psychological well-being and mental health

Introduction. World Health Organization estimated that up to 20% of children and adolescents suffer from a problem of psychological or behavioural development worldwide and one in eight suffers from a mental disorder. Interventions promoting positive mental health may provide young people with necessary life skills to prevent mental health disorders.Methods. Computer and communication technologies are becoming more and more popular for life skills training programs. However, learning styles and communication technologies preferences of young people is understudied. Focus group interviews was used.Results. Participants were 283 students of five European countries (Bulgaria, Italy, Lithuania, Poland, and United Kingdom). The majority of preferences indicated smartphone to communicate or to get information, tablet for a better use in classroom and collaborative games for digital interactive educational activities.Conclusions. There is a need to encourage teachers to use this technology at school to improve students’ productivity and their emotional and social abilities

A student manual for promoting mental health among high school students

OBJECTIVES. We describe a school program based on a student manual for promoting mental health and preventing mental illness. METHODS. A preliminary version of the manual was assessed for face validity by two focus groups. The final version was evaluated for acceptability among 253 students in 10 high schools and 1 middle school in Italy. RESULTS. The manual included 18 chapters (or "units") which address skills for enabling students to cope with their daily lives: communication skills, problem-solving, assertive skills, negotiation, stress management, anger management and conflict resolution. The manual was found to have been acceptable by high school students. CONCLUSIONS. The effectiveness of the manual in actually promoting mental health and preventing mental illness is currently being evaluated

Validation and reference values of the EORTC QLQ-CML24 questionnaire to assess health-related quality of life in patients with chronic myeloid leukemia

Health-related quality of life (HRQOL) assessment is important to facilitate decisions in the current treatment landscape of chronic myeloid leukemia (CML). Therefore, the availability of a validated HRQOL questionnaire, specifically developed for CML patients treated with tyrosine kinase inhibitors (TKIs), may enhance quality of research in this area. We performed an international study including 782 CML patients to assess the validity of the EORTC QLQ-CML 24 questionnaire, and to generate HRQOL reference values to facilitate interpretation of results in future studies. Internal consistency, assessed with Cronbach's alpha coefficients, ranged from 0.66 to 0.83. In the confirmatory factor analysis, all standardized factor loadings exceeded the threshold of 0.40 (range 0.49-0.97), confirming the hypothesized scale structure. Reference values stratified by age and sex were also generated. Our findings support the use of the EORTC QLQ-CML 24, in conjunction with the EORTC QLQ-C30, as a valuable measure to assess HRQOL in CML patients

Eltrombopag for Low-Risk Myelodysplastic Syndromes With Thrombocytopenia: Interim Results of a Phase-II, Randomized, Placebo-Controlled Clinical Trial (EQOL-MDS)

Purpose: In myelodysplastic syndromes (MDS), severe thrombocytopenia is associated with poor prognosis. This multicenter trial presents the second-part long-term efficacy and safety results of eltrombopag in patients with low-risk MDS and severe thrombocytopenia. Methods: In this single-blind, randomized, placebo-controlled, phase-II trial of adult patients with International Prognostic Scoring System low- or intermediate-1-risk MDS, patients with a stable platelet (PLT) count (&lt;30 × 103/mm3) received eltrombopag or placebo until disease progression. Primary end points were duration of PLT response (PLT-R; calculated from the time of PLT-R to date of loss of PLT-R, defined as bleeding/PLT count &lt;30 × 103/mm3 or last date in observation) and long-term safety and tolerability. Secondary end points included incidence and severity of bleeding, PLT transfusions, quality of life, leukemia-free survival, progression-free survival, overall survival and pharmacokinetics. Results: From 2011 to 2021, of 325 patients screened, 169 patients were randomly assigned oral eltrombopag (N = 112) or placebo (N = 57) at a starting dose of 50 mg once daily to maximum of 300 mg. PLT-R, with 25-week follow-up (IQR, 14-68) occurred in 47/111 (42.3%) eltrombopag patients versus 6/54 (11.1%) in placebo (odds ratio, 5.9; 95% CI, 2.3 to 14.9; P &lt; .001). In eltrombopag patients, 12/47 (25.5%) lost the PLT-R, with cumulative thrombocytopenia relapse-free survival at 60 months of 63.6% (95% CI, 46.0 to 81.2). Clinically significant bleeding (WHO bleeding score ≥ 2) occurred less frequently in the eltrombopag arm than in the placebo group (incidence rate ratio, 0.54; 95% CI, 0.38 to 0.75; P = .0002). Although no difference in the frequency of grade 1-2 adverse events (AEs) was observed, a higher proportion of eltrombopag patients experienced grade 3-4 AEs (χ2 = 9.5, P = .002). AML evolution and/or disease progression occurred in 17% (for both) of eltrombopag and placebo patients with no difference in survival times. Conclusion: Eltrombopag was effective and relatively safe in low-risk MDS with severe thrombocytopenia. This trial is registered with ClinicalTrials.gov identifier: NCT02912208 and EU Clinical Trials Register: EudraCT No. 2010-022890-33