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In VIVRE (NCT04448431), vortioxetine was associated with significantly higher rates of symptomatic and functional remission, better daily and social functioning, and greater treatment satisfaction than desvenlafaxine in patients with major depressive disorder (MDD) and partial response to selective serotonin reuptake inhibitor (SSRI) therapy. This analysis further explored the relative improvement in patient functioning with vortioxetine versus desvenlafaxine.
Methods
VIVRE was a randomized, double-blind study of vortioxetine (10 or 20 mg/day) versus desvenlafaxine (50 mg/day) in adults with MDD and partial response to initial SSRI monotherapy. Mean percentage changes from baseline to week 8 in Functioning Assessment Short Test (FAST) total and domain scores were analyzed by treatment group in the overall population and in working patients.
Results
In the overall population, the mean reduction in FAST total score from baseline after 8 weeks of treatment was 37.2% in vortioxetine-treated patients versus 31.8% in desvenlafaxine-treated patients (P = 0.04). Significantly greater improvements versus desvenlafaxine were seen in vortioxetine-treated patients for FAST autonomy, cognitive functioning, and interpersonal-relationships scores (all P < 0.05). In working patients, the mean reduction in FAST total score from baseline at week 8 was 38.7% versus 32.1% in the vortioxetine and desvenlafaxine groups, respectively (P = 0.04). Significant correlations were seen between absolute changes in patient functioning, and those in depression severity and health-related quality of life.
Conclusion
Vortioxetine was significantly better than desvenlafaxine in improving overall functioning as well as daily, social, and cognitive functioning in patients with MDD with inadequate response to prior SSRI therapy.
Vortioxetine has demonstrated dose-dependent efficacy in patients with major depressive disorder (MDD), with the greatest effect observed with vortioxetine 20 mg/day. This analysis further explored the clinical relevance of the more rapid and greater improvement in depressive symptoms observed with vortioxetine 20 mg/day vs 10 mg/day.
Methods
Analysis of pooled data from six short-term (8-week), randomized, placebo-controlled, fixed-dose studies of vortioxetine 20 mg/day in patients with MDD (N = 2620). Symptomatic response (≥50% decrease in Montgomery–Åsberg Depression Rating Scale [MADRS] total score), sustained symptomatic response, and remission (MADRS total score ≤10) were assessed by vortioxetine dosage (20 or 10 mg/day).
Results
After 8 weeks, 51.4% of patients receiving vortioxetine 20 mg/day had achieved symptomatic response vs 46.0% of those receiving vortioxetine 10 mg/day (P < .05). Significantly more patients achieved symptomatic response vs placebo from week 2 onwards for vortioxetine 20 mg/day and from week 6 onwards for vortioxetine 10 mg/day (both P ≤ .05). Sustained response was achieved from week 4 for 26.0% of patients receiving vortioxetine 20 mg/day vs 19.1% of those receiving vortioxetine 10 mg/day (P < .01), increasing to 36.0% and 29.8%, respectively, over the 8-week treatment period (P < .05). At week 8, 32.0% of patients receiving vortioxetine 20 mg/day were in remission vs 28.2% of those receiving vortioxetine 10 mg/day (P = .09). Rates of adverse events and treatment withdrawal were not increased during the week following vortioxetine dose up-titration to 20 mg/day.
Conclusion
Vortioxetine 20 mg/day provides more rapid and more sustained symptomatic response than vortioxetine 10 mg/day in patients with MDD, without compromising tolerability.
The experience of care giving inventory (ECI) is a self-reported measure of the caregiving experience as seen by the carer of a person with a serious mental illness. It comprises eight negative subscales and two positive subscales; positive and negative scores are obtained from these (ECI total positive and ECI total negative). This study aims to assess the validity and the reliability of the Italian version of the ECI and to compare the experience of carers in London and Bologna as measured by the ECI.
Method.
The sample consisted of 95 Bologna carers and 69 London carers of patients suffering from a functional psychotic disorder. The internal consistency of the Italian ECI and correlation between the Italian ECI total negative and the GHQ-12 (external validity) were estimated. Independent t-tests and chi-squared tests were used to compare sample characteristics and mean ECI scores. Regression analyses were used to control for confounders.
Results.
Internal consistency and validity of the Italian ECI were similar to these previously found. The Bologna caregivers had a higher ECI total negative than London carers; this difference was partially explained by worse patients' functioning and by a higher proportion of parents in Bologna. Bologna carers scored significantly lower on ECI total positive after controlling for relationship and patient functioning.
Conclusions.
The Italian ECI is a well-accepted and valid instrument to describe caregiving experiences. The similar scores in ECI total negative between London and Bologna underline a cross-cultural consistency of negative experience of caregiving and re-emphasise the importance of patients functioning in different cultural contexts. The differences found for ECI total positive suggest area for further research.
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