ObjectiveThis randomised, double-blind, 12-week study compared efficacy and tolerability of flexible-dose treatment with vortioxetine (10–20 mg/day) versus agomelatine (25–50 mg/day) in major depressive disorder patients with inadequate response to selective serotonin reuptake inhibitor (SSRI)/serotonin–noradrenaline reuptake inhibitor (SNRI) monotherapy.MethodsPatients were switched directly from SSRI/SNRI to vortioxetine or agomelatine. Primary endpoint was change from baseline to week 8 in the Montgomery–Åsberg Depression Rating Scale (MADRS) total score analysed by mixed model for repeated measurements, using a noninferiority test followed by a superiority test. Secondary endpoints included response and remission rates, anxiety symptoms (Hamilton Anxiety Rating Scale), Clinical Global Impression, overall functioning (Sheehan Disability Scale), health-related quality of life (EuroQol 5 Dimensions), productivity (work limitation questionnaire) and family functioning (Depression and Family Functioning Scale).ResultsPrimary endpoint noninferiority was established and vortioxetine (n = 252) was superior to agomelatine (n = 241) by 2.2 MADRS points (p < 0.01). Vortioxetine was also significantly superior in response and remission rates at weeks 8 and 12; MADRS, Hamilton Anxiety Rating Scale, Clinical Global Impression, Sheehan Disability Scale and EuroQol 5 Dimensions scores at week 4 onwards; work limitation questionnaire at week 8 and Depression and Family Functioning Scale at weeks 8 and 12. Fewer patients withdrew because of adverse events with vortioxetine (5.9% vs 9.5%). Adverse events (incidence ≥5%) were nausea, headache, dizziness and somnolence.ConclusionsVortioxetine was noninferior and significantly superior to agomelatine in major depressive disorder patients with previous inadequate response to a single course of SSRI/SNRI monotherapy. Vortioxetine was safe and well tolerated.
The experience of having a severe disease such as major depression affects all aspects of the individual's life, including family, work, and social functioning. Therefore, the aim of this study was to describe, from a salutogenic approach, women's conceptions of coping with major depression in daily life with the help of professional and lay support. Thirteen women, previously hospitalized for major depression, were included in the study. The women were selected by strategic sampling, and data were analyzed by application of a phenomenographic approach. Four descriptive categories emerged: Self-Healing, Managing, Receiving Social Support, and Finding Meaning. While working their way out of the depression, the women needed to undergo a process of transition, involving both a cognitive and an emotional understanding, which they subsequently translated into health-related actions. The task of psychiatric mental health nurses is to provide care that empowers patients. Future nursing research should explore the circumstances that empower these women to start the transition process, as this process appears to be vital for recovery from major depression.
Major depression is a common illness, with a lifetime prevalence rate of 10-13% for men and 21-24% for women. The experience of having a serious illness such as major depression affects the individual's quality of life and requires significant adaptation in order to cope. The aim of this study was to explore sense of coherence and social support in patients treated for a first episode of major depression in a 1-year follow up. The study design was prospective and longitudinal. A total of 24 patients, aged 18 years or over, with a first episode of major depression were included. Semi-structured interviews and self-assessment questionnaires were used at baseline as well as in a 1-year follow up in order to measure the level of severity of the depression, social support, and sense of coherence. The result showed that 71% of the patients had recovered at follow up. The sense of coherence scores were low at baseline, although the patients who recovered increased their sense of coherence scores significantly. Another factor of importance for recovery was a significant increase in social support. Social support is an important cornerstone in the restoration of a person's sense of coherence. It can be used in interventions that include the patient's family or close social network in combination with support to assist the patient to view his/her situation as comprehensible, manageable, and meaningful, thereby promoting or improving health. Mental health nurses are in a key position to identify patients' strengths and weaknesses so that the support and interventions provided can be tailored to meet the needs of each patient.
On the basis of 3-week studies, lithium and valproate are both recommended for first-line treatment of acute mania. It is, however, also important to demonstrate that antimanic efficacy can be maintained. This study has been designed to compare the efficacy and tolerability of valproate and lithium over 12 weeks in the treatment of acute mania in patients with type I bipolar disorder. Three hundred patients with bipolar I disorder presenting with acute mania were randomized to open treatment with lithium (starting dose: 400 mg/day) or valproate (starting dose: 20 mg/kg/day) for 12 weeks. The primary efficacy criterion was remission (YMRS score or=2 on the CGI-BP severity scale). Remission rates were 65.5% (lithium group) and 72.3% (valproate group). Noninferiority of valproate with respect to lithium was demonstrated [between-group difference: 6.78% (95% confidence intervals: -3.80 to 17.36%)]. Remission rates assessed by the secondary mixed model repeated measures analysis were significantly greater with valproate than with lithium. Adverse events were reported in 44% of patients in both groups. Valproate and lithium showed comparable efficacy and tolerability in the treatment of acute mania over 12 weeks.
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