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Fictional patients used for illustrative purposes.

After Samantha started taking her SSRIs at the start of this year, she saw an improvement in her symptoms of low mood and hopelessness and finally felt like she was out of the woods.

But after a few months, she stopped taking her treatment due to experiencing side-effects related to sexual functioning.2 Now she’s finding it a struggle to get out of bed again, so she’s worried that she’s experiencing a relapse.

Recurrence / relapse in MDD

As many as 1 in 4 individuals who recover from a major depressive episode will have a recurrence within the first year3

Brintellix may help people like Samantha by improving rates of remission (vs. agomelatine)4 and reducing the risk of relapse (vs. placebo)5

MDD, major depressive disorder; SSRI, selective serotonin reuptake inhibitor.

Brintellix demonstrates significantly better rates of remission vs. agomelatine in patients with MDD who had suboptimal responses to SSRI/SNRI therapy4

  • Primary endpoint established noninferiority and showed that Brintellix was superior to agomelatine by 2.2 MADRS points at week 8 (p<0.01; as measured by MADRS†)
  • Brintellix was also significantly superior in response rates at Weeks 8 and 12 vs. agomelatine (p<0.01; MADRS responders)
  • The NNT vs. agomelatine for remission at Week 12 was 7 – for every 7 patients treated with Brintellix, 1 additional patient achieved remission than with agomelatine
MADRS remission rates†
Adapted from: Montgomery SA et al. 2014.⁴ †As measured by MADRS: FAS, MMRM by visit and LOCF (FAS, ANCOVA) at Week 8; ‡p<0.01; §p<0.001 vs. agomelatine. Remission was defined as MADRS total score ≤10 or CGI-S ≤2. At week 8, 40.5% (102/252) of patients treated with Brintellix were considered MADRS remitters, vs 29.5% (71/241) of patients treated with agomelatine (LOCF; p<0.01). Patients included in this study had a mean MADRS baseline score total score of 28.9 and item score (apparent sadness) of ≥3 at screening and baseline and were non or partially responsive to a single treatment course of SSRI or SNRI for ≥6 Weeks. SSRI - citalopram, escitalopram, paroxetine, sertraline; SNRI - duloxetine or venlafaxine.

ANCOVA, analysis of covariance; FAS, full analysis set; HAM-D, Hamilton Depression Rating Scale; LOCF, last observation carried forward; MADRS, Montgomery-Åsberg Depression Rating Scale; MMRM, mixed model for repeated measures; NNT, number needed to treat; SNRI, serotonin and noradrenaline reuptake inhibitor; SSRI, selective serotonin reuptake inhibitor.

Fictional patients used for illustrative purposes.

Brintellix significantly reduces the risk of relapse vs. placebo in patients with remitted MDD5

  • In the 48-week, relapse-prevention RESET study, all doses of Brintellix were effective for relapse prevention (5, 10 and 20 mg doses)5
  • Time to relapse was longer and cumulative rates were lower for all Brintellix doses vs. placebo over 28 weeks (p<0.05 for all):5
    • Brintellix 5 mg (19.3% vs. placebo 32.5%)
    • Brintellix 10 mg (17.9% vs. placebo 32.5%)
    • Brintellix 20 mg (17.4% vs. placebo 32.5%)
MDD, Major Depressive Disorder.
Fictional patients used for illustrative purposes.

Brintellix effectively lessens the burden of depression over the long term3

In a pooled post hoc analysis of the effectiveness, safety and tolerability of Brintellix during five long-term (52-week) open-label extension studies of people with MDD:3

  • Maintenance therapy with Brintellix was associated with continued improvement from baseline in depressive symptoms, assessed by mean MADRS total scores over 52 weeks
  • Anxiety symptoms also improved with long-term maintenance therapy (assessed by HAM-A total score and the global severity impression assessed by CGI-S score)
Mean MADRS total scores in randomised controlled trials followed by open-label extension studies (n=1230, LOCF)
Adapted from: Vieta E et al. 2017.3 Mean MADRS total scores from a pooled analysis of patients previously treated with Brintellix 5-20 mg/day in five six-to-eight-week long-term, open-label, randomised controlled trials who continued treatment in an open-label extension study (n=1230) (LOCF). The vertical line represents the start of treatment in the extension phase. The horizontal dashed line indicates the threshold for remission, as defined by MADRS total score ≤10. Limitations: Because this was a post hoc analysis, the power to assign statistical significance to differences in outcome measure was limited.

HAM-A, Hamilton Anxiety Rating Scale; LOCF, last observation carried forward; MADRS, Montgomery-Åsberg Depression Rating Scale; MDD, Major Depressive Disorder; MDE, major depressive episode.

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.
  • Jacobsen PL et al. J Sex Med 2015;12:2036–2048.
  • Vieta E, et al. European Neuropsychopharmacology. 2017;27(9):877-884.
  • Montgomery SA et al. Hum Psychopharmacol 2014;29:470–482.
  • Thase ME et al. J Affect Disord 2022;303:123–130.
UK-BRIN-1284 | September 2023

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