42847922MDD3005 OARS

• Research type

  Research Study

• Full title

  A Double-Blind, Randomized, Parrallel-Group Study with Quetiapine Extended Release as Comparator to Evaluate the efficacy and safety of Seltorexant 20mg as Adjunctive Therapy to Antidepressants in Adults and Elderly Patients with Major Depressive Disorder with Insomnia Symptoms Who Have Responded Inadequately to Antidepressant Therapy

• IRAS ID

  283342

• Contact name

  David Wright

• Contact email

  JCI-Office@its.jnj.com

• Sponsor organisation

  Janssen Cilag Internation NV

• Eudract number

  2020-000341-14

• Duration of Study in the UK

  2 years, 2 months, 1 days

• Research summary

  Major Depressive Disorder (MDD) is a common, serious and recurrent mood disorder. Its impact on daily life e.g. school performance, marriage, parenting, quality of life, physical health and life expectancy has been well documented. Inadequate response to first-line MDD treatments such as anti-depressants (selective serotonin reuptake inhibitor (SSRI) or serotonine-noerepinephrine reuptake inhibitor (SNRI is common and therefore represents an important unmet medical need. Currently approved drugs indicated for adjunctive therapy in patients with MDD have tolerability issues that, in some cases, may lead to non-adherence, or early discontinuation. Additionally, about two-thirds of depressed patients take sleep medications in addition to their antidepressant regimen for insomnia symptoms.
  Seltorexant is a novel, high affinity/high potency oral selective orexin 2 receptor (OX2R) antagonist (SORA) being developed as a valuable alternative in the treatment of MDD, without the side effects observed with other medications.

  Multiple studies show the benefit of seltorexant on improving symptoms of depression in participants with MDD in depressed participants. This benefit is greatest in MDD patients with insomnia symptoms (MDDIS). This study will evaluate the safety and efficacy of Seltorexant as an antidepressant therapy in adults (aged 18-64 years) and elderly (aged 65-74years) with MDDIS who have an inadequate response to treatment with an SSRI or SNRI. This study will compare potential differentiating features between seltorexant (20mg) and quetiapine XR (150mg or 300mg), as adjunctive treatment to an antidepressant and will run for 26weeks in multiple centres.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  20/EE/0217

• Date of REC Opinion

  30 Oct 2020

• REC opinion

  Further Information Favourable Opinion