11 research outputs found

    Meaning and medication: a thematic analysis of depressed adolescents’ views and experiences of SSRI antidepressants alongside psychological therapies

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    Abstract Background Adolescence is a key period of risk for the emergence of Major Depressive Disorder (MDD). The prescription of selective serotonin re-uptake inhibitors (SSRIs) for the treatment of depression in adolescents is an issue of worldwide controversy, and evidence regarding their safety and efficacy is inconclusive. In the UK, NICE guidelines have recently recommended offering SSRIs to adolescents alongside psychological therapy or on their own if therapy is refused. Thus, SSRIs are increasingly becoming a major component of treatment for adolescents. This study qualitatively explored adolescents’ views and experiences of SSRIs within their accounts of engaging in a psychological therapy for depression, particularly focusing on meanings they attached to medication-use. Methods The qualitative study reports data from semi-structured interviews conducted 12-months post-treatment with 12 adolescents who were clinically referred and treated for depression as part of the IMPACT trial. The interviews were analysed using Thematic Analysis. Results Four themes were identified: ‘a perceived threat to autonomy’, ‘a sign of severity’, ‘a support, not a solution’, and ‘an ongoing process of trial and error’. Conclusions This study highlights the value of bringing adolescents’ voices into the broader debate on the use of antidepressants in their age group and in the development of future guidelines. Future implications for research and clinical practice are discussed

    Patient-Level Pooled Analysis of Ultrasound Renal Denervation in the Sham-Controlled RADIANCE II, RADIANCE-HTN SOLO, and RADIANCE-HTN TRIO Trials

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    IMPORTANCE: Ultrasound renal denervation (uRDN) was shown to lower blood pressure (BP) in patients with uncontrolled hypertension (HTN). Establishing the magnitude and consistency of the uRDN effect across the HTN spectrum is clinically important. OBJECTIVE: To characterize the effectiveness and safety of uRDN vs a sham procedure from individual patient-level pooled data across uRDN trials including either patients with mild to moderate HTN on a background of no medications or with HTN resistant to standardized triple-combination therapy. DATA SOURCES: A Study of the ReCor Medical Paradise System in Clinical Hypertension (RADIANCE-HTN SOLO and TRIO) and A Study of the ReCor Medical Paradise System in Stage II Hypertension (RADIANCE II) trials. STUDY SELECTION: Trials with similar designs, standardized operational implementation (medication standardization and blinding of both patients and physicians to treatment assignment), and follow-up. DATA EXTRACTION AND SYNTHESIS: Pooled analysis using individual patient-level data using linear regression models to compare uRDN with sham across the trials. MAIN OUTCOMES AND MEASURES: The primary outcome was baseline-adjusted change in 2-month daytime ambulatory systolic BP (dASBP) between groups. RESULTS: A total of 506 patients were randomized in the 3 studies (uRDN, 293; sham, 213; mean [SD] age, 54.1 [9.3]; 354 male [70.0%]). After a 1-month medication stabilization period, dASBP was similar between the groups (mean [SD], uRDN, 150.3 [9.2] mm Hg; sham, 150.8 [10.5] mm Hg). At 2 months, dASBP decreased by 8.5 mm Hg to mean (SD) 141.8 (13.8) mm Hg among patients treated with uRDN and by 2.9 mm Hg to 147.9 (14.6) mm Hg among patients treated with a sham procedure (mean difference, -5.9; 95% CI, -8.1 to -3.8 mm Hg; P < .001 in favor of uRDN). BP decreases from baseline with uRDN vs sham were consistent across trials and across BP parameters (office SBP: -10.4 mm Hg vs -3.4 mm Hg; mean difference, -6.4 mm Hg; 95% CI, -9.1 to -3.6 mm Hg; home SBP: -8.4 mm Hg vs -1.4 mm Hg; mean difference, -6.8 mm Hg; 95% CI, -8.7 to -4.9 mm Hg, respectively). The BP reductions with uRDN vs sham were consistent across prespecified subgroups. Independent predictors of a larger BP response to uRDN were higher baseline BP and heart rate and the presence of orthostatic hypertension. No differences in early safety end points were observed between groups. CONCLUSIONS AND RELEVANCE: Results of this patient-level pooled analysis suggest that BP reductions with uRDN were consistent across HTN severity in sham-controlled trials designed with a 2-month primary end point to standardize medications across randomized groups. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02649426 and NCT03614260
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