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A randomised, double-blind study in adults with major depressive disorder with an inadequate response to a single course of selective serotonin reuptake inhibitor or serotonin-noradrenaline reuptake inhibitor treatment switched to vortioxetine or agomelatine.

Montgomery SA, Nielsen RZ, Poulsen LH, Häggström L - Hum Psychopharmacol (2014)

Bottom Line: Primary 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.Vortioxetine was safe and well tolerated.

View Article: PubMed Central - PubMed

ABSTRACT

Objective: This 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.

Methods: Patients 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).

Results: Primary 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.

Conclusions: Vortioxetine 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.

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Related in: MedlinePlus

Estimated change in Montgomery–Åsberg Depression Rating Scale (MADRS) total scores from baseline to week 12 (FAS and MMRM by visit) and LOCF (FAS and ANCOVA) at week 12. FAS, full-analysis set; LOCF, last observation carried forward; MMRM, mixed model repeated measures. Patient numbers at each visit are shown below the x-axis for each treatment group. **p < 0.01; ***p < 0.001 versus agomelatine. The primary endpoint is at week 8 (FAS and MMRM)
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fig03: Estimated change in Montgomery–Åsberg Depression Rating Scale (MADRS) total scores from baseline to week 12 (FAS and MMRM by visit) and LOCF (FAS and ANCOVA) at week 12. FAS, full-analysis set; LOCF, last observation carried forward; MMRM, mixed model repeated measures. Patient numbers at each visit are shown below the x-axis for each treatment group. **p < 0.01; ***p < 0.001 versus agomelatine. The primary endpoint is at week 8 (FAS and MMRM)

Mentions: At week 12, the MADRS total mean score decreased (improved) from 29.1 at baseline to 9.9 (vortioxetine) and from 28.7 to 11.9 (agomelatine) (FAS and MMRM). Vortioxetine was significantly superior to agomelatine (p < 0.05) in reducing the MADRS total score from week 4 onwards (MMRM) (Figure 3) and from week 3 onwards (ANCOVA and LOCF). Vortioxetine was significantly superior to agomelatine in response and remission at week 8 and onwards. At week 12, 69.8% of the patients in the vortioxetine group were MADRS responders compared with 56.0% of the patients in the agomelatine group, and 55.2% of the patients in the vortioxetine group were MADRS remitters compared with 39.4% of the patients in the agomelatine group (LOCF; p < 0.01) (Figure 2). In addition, vortioxetine separated from agomelatine during the 12-week study for each of the MADRS single items at weeks 8, 12 or earlier with the exception of ‘inability to feel’ and ‘reduced sleep’ (FAS and MMRM).


A randomised, double-blind study in adults with major depressive disorder with an inadequate response to a single course of selective serotonin reuptake inhibitor or serotonin-noradrenaline reuptake inhibitor treatment switched to vortioxetine or agomelatine.

Montgomery SA, Nielsen RZ, Poulsen LH, Häggström L - Hum Psychopharmacol (2014)

Estimated change in Montgomery–Åsberg Depression Rating Scale (MADRS) total scores from baseline to week 12 (FAS and MMRM by visit) and LOCF (FAS and ANCOVA) at week 12. FAS, full-analysis set; LOCF, last observation carried forward; MMRM, mixed model repeated measures. Patient numbers at each visit are shown below the x-axis for each treatment group. **p < 0.01; ***p < 0.001 versus agomelatine. The primary endpoint is at week 8 (FAS and MMRM)
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4265248&req=5

fig03: Estimated change in Montgomery–Åsberg Depression Rating Scale (MADRS) total scores from baseline to week 12 (FAS and MMRM by visit) and LOCF (FAS and ANCOVA) at week 12. FAS, full-analysis set; LOCF, last observation carried forward; MMRM, mixed model repeated measures. Patient numbers at each visit are shown below the x-axis for each treatment group. **p < 0.01; ***p < 0.001 versus agomelatine. The primary endpoint is at week 8 (FAS and MMRM)
Mentions: At week 12, the MADRS total mean score decreased (improved) from 29.1 at baseline to 9.9 (vortioxetine) and from 28.7 to 11.9 (agomelatine) (FAS and MMRM). Vortioxetine was significantly superior to agomelatine (p < 0.05) in reducing the MADRS total score from week 4 onwards (MMRM) (Figure 3) and from week 3 onwards (ANCOVA and LOCF). Vortioxetine was significantly superior to agomelatine in response and remission at week 8 and onwards. At week 12, 69.8% of the patients in the vortioxetine group were MADRS responders compared with 56.0% of the patients in the agomelatine group, and 55.2% of the patients in the vortioxetine group were MADRS remitters compared with 39.4% of the patients in the agomelatine group (LOCF; p < 0.01) (Figure 2). In addition, vortioxetine separated from agomelatine during the 12-week study for each of the MADRS single items at weeks 8, 12 or earlier with the exception of ‘inability to feel’ and ‘reduced sleep’ (FAS and MMRM).

Bottom Line: Primary 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.Vortioxetine was safe and well tolerated.

View Article: PubMed Central - PubMed

ABSTRACT

Objective: This 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.

Methods: Patients 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).

Results: Primary 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.

Conclusions: Vortioxetine 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.

Show MeSH
Related in: MedlinePlus