Human psychopharmacologyAug 5, 2014

Switching to Vortioxetine or Agomelatine in Adults with Major Depression Not Improved by One SSRI or SNRI Treatment: A Randomized, Double-Blind Study

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Abstract

Vortioxetine was superior to agomelatine by 2.2 points in reducing depression symptoms after 12 weeks.

Noninferiority of vortioxetine was established compared to agomelatine for patients with major depressive disorder.
Significantly higher response and remission rates were observed with vortioxetine at weeks 8 and 12.
Improvements in anxiety symptoms, overall functioning, health-related quality of life, productivity, and family functioning were noted with vortioxetine starting from week 4.
Withdrawal due to adverse events was lower in the vortioxetine group (5.9%) compared to the agomelatine group (9.5%).
Common adverse events for both treatments included nausea, headache, dizziness, and somnolence.

Simplified

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 (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.

Key numbers

2.2

Mean Difference in Score

Change from baseline to week 8 in total score

69.8%

Response Rate at Week 12

Percentage of patients achieving response based on

5.9%

Withdrawal Rate Due to Adverse Events

Percentage of patients withdrawing from treatment due to adverse events

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Switching to Vortioxetine or Agomelatine in Adults with Major Depression Not Improved by One SSRI or SNRI Treatment: A Randomized, Double-Blind Study

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