Rapastinel Versus placebo to prevent relapse of Major depression
Research type
Research Study
Full title
A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Rapastinel in the Prevention of Relapse in Patients with Major Depressive Disorder
IRAS ID
254934
Contact name
Allen Young
Contact email
Sponsor organisation
Allergan Ltd.
Eudract number
2018-000064-28
Duration of Study in the UK
2 years, 8 months, 19 days
Research summary
Major depressive disorder (MDD) is a highly disabling, serious condition which is associated with significant morbidity and mortality. MDD affects approximately 14.8 million American adults, or about 6.7% of the US population 18 years of age and older, in a given year. Worldwide, about 15% of the adult population is at lifetime risk of developing MDD. MDD is known to be a significant risk factor for suicide and ischemic heart disease. Research has shown that untreated depression has both a functional (social and work role) as well as a neuroanatomical (hippocampal shrinkage) effect on the patient. Given the disease burden and link to suicidality as well as increased mortality with other comorbid conditions, MDD is a serious and life-threatening condition which is a leading cause of disability in the world.
The main aim of the study is to evaluate the efficacy, safety, and tolerability of rapastinel relative to placebo in the prevention of relapse in patients with major depressive disorder (MDD). Also the study will evaluate the psychotomimetic, dissociative and psychomotor effects of rapastinel in the maintenance treatment of MDD.
This study will be performed at approximately 145 study centers in North America, Europe, and Asia. The study will enrol approx1400 male and female participants aged between 18-74 years with Major depressive disorder will be eligible for the study who participated in a lead-in study (either study RAP-MD-30, RAP-MD-31, or RAP-MD-32).
Once selected, as part of the first part of the study participants will be randomised to receive study drug under two groups. These two groups are based on amount of dose of the study drug participants will receive. Depending on what happens during the first part of the study, participants will continue to the second part of the study. In second part of the study participants will be randomised to receive study drug or placebo under three groups. Participants will be in the study for approximately 70 weeks (16 months).REC name
HSC REC B
REC reference
19/NI/0079
Date of REC Opinion
19 Apr 2019
REC opinion
Unfavourable Opinion