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Fictional patients used for illustrative purposes.

Ever since Peter’s father died suddenly, he’s been struggling to cope with the trauma of that day on top of his MDD. This has impacted him in many ways, including causing him to lose his job as a care worker. As a result he is now looking for work again, making it particularly important for Peter to manage his MDD.

But for people like Peter with a history of MDD and trauma, who have experienced recent life stressors, there is a greater risk of non-recovery from MDD, suicidality, psychiatric and medical comorbidity, chronicity and health service utilisation.2

MDD and trauma:

Patients with MDD who self-report childhood-trauma or recent life stressors exhibit diminished response to antidepressant therapy and are at higher risk for recurrence of major depressive episodes2

Brintellix may help people like Peter with MDD and a history of trauma by reducing depressive symptoms and the risk of relapse (vs. placebo)2

MDD, major depressive disorder.  

Brintellix shows efficacy in patients with MDD and a history of trauma vs. placebo – short-term treatment2

Data from a meta-analysis of four short-term, placebo-controlled efficacy studies (8 weeks; n=1811):2

  • Brintellix was shown to be effective as a short-term treatment and relapse prevention strategy in patients with MDD reporting childhood or recent trauma*
*as measured by MADRS

Study limitations2

All analyses were conducted post hoc, preventing any conclusive statements on the unique effect of Brintellix in patients diagnosed with MDD with childhood or recent trauma. In a meta-analysis with subgroups on several endpoints for four doses, the overall results (rather than the result of a single analysis) should be considered for the different endpoints within each subgroup.

Difference in mean change in MADRS total score from baseline vs. placebo at Week 6/8, according to trauma status (FAS)
Adapted from: Christensen MC et al. 2020.2 †p<0.05. The difference versus placebo on the MADRS was -2.3 for Brintellix 5 mg (p=0.099), -2.2 for 10mg (p=0.025), and -4.4 for 20mg (p<0.001) in patients with any trauma (childhood and/or recent). Brintellix 15 mg is not available for use in the UK.

FAS, Full Analysis Set; MADRS, Montgomery-Åsberg Depression Rating Scale; MDD, major depressive disorder.

In adult MDD patients with a history of trauma, long-term treatment with Brintellix (5 or 10 mg) significantly improved vs. placebo:2

  • Depressive symptoms
  • Anxiety symptoms
  • Overall functioning
  • Health-related quality of life and lowered the risk of relapse (as measured by MADRS, HAM-A, SDS, SF-36)
Difference in mean change from baseline II vs. placebo at Week 48 (FAS)
Adapted from: Christensen MC et al. 2020.2 †p<0.05. Baseline II: baseline score after 20 weeks of treatment and before randomisation.

FAS, Full Analysis Set; HAM-A, Hamilton Anxiety Rating Scale; HRQoL, health-related quality of life; MADRS, Montgomery-Åsberg Depression Rating Scale; MDD, major depressive disorder; QoL, quality of life; SDS, Sheehan Disability Scale; SF-36, 36-Item Short Form Health Survey.

MDD and anxiety:

Patients with MDD who are affected by anxiety and depressive symptoms concurrently have generally shown greater function disability, higher risk of suicidal ideation and behaviour, and increased utilisation of healthcare resources, compared with patients who have MDD without anxiety disorders3

In patients with MDD and high levels of anxiety at baseline, Brintellix significantly improves anxiety vs. placebo4 (5 and 10 mg doses)

In a 6-week, randomised, double-blind, placebo-controlled, fixed-dose, active-referenced study comparing the efficacy and safety of Brintellix in adult patients with MDD:4

  • In MDD patients with high levels of anxiety (mean baseline HAM-A score of 22.2): Brintellix demonstrated statistically significant differences from placebo in HAM-A total score at study endpoint (p<0.001 vs. placebo for 5 and 10 mg doses) – secondary endpoint
  • The primary endpoint (mean change in MADRS total score from baseline vs. placebo) was met for both doses
Mean change in HAM-A total score from baseline in adult patients with MDD (FAS)
Adapted From: Alvarez E et al. 2012.⁴ *p<0.05, †p<0.01, ‡p<0.001 vs. placebo. From a randomised double-blind, placebo-controlled, fixed dose, active-referenced study comparing the efficacy and safety of Brintellix in adult patients with MDD, as defined by a MADRS total score of ≥30. Mean change from baseline in Hamilton rating scale for anxiety (HAM-A) total scores (ANCOVA, FAS, OC, over time) and LOCF (Week 6). Mean baseline HAM-A score was 22.2, representing a substantial level of anxiety. Venlafaxine was included as an active reference for study validation, not for comparison of effect size. Some patients were excluded due to the use of a non-validated scale in France.

ANCOVA, analysis of covariance; FAS, full analysis set; HAM-A, Hamilton Anxiety Rating Scale; LOCF, last observation carried forward; MADRS, Montgomery-Åsberg Depression Rating Scale; MDD, major depressive disorder; OC, observed cases.

For further information about Brintellix, including Tolerability, Special Warnings and Precautions and Contraindications, please visit the About Brintellix Section

about brintellix

Explore more in the sections below:

Adverse events should be reported.

Reporting forms and information can be found at http://www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Adverse events should also be reported to Lundbeck Limited, Medical Information, on: 01908 638972 or Email: SafetyLuUnitedKingdom@lundbeck.com

References
  • Lundbeck. Brintellix. Summary of Product Characteristics GB and NI.
  • Christensen MC et al. J Affect Disord 2020;263:258–266.
  • Baldwin DS et al. J Affect Disord 2016;206:140–150.
  • Alvarez E et al. Int J Neuropsychopharmacol 2012;15(5):589–600.
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