Trial Profile
A Phase 2a Proof-of-Concept Study of R-107 for the Treatment of Refractory Major Depressive Disorder
Status:
Completed
Phase of Trial:
Phase II
Latest Information Update: 25 Nov 2022
Price :
$35
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At a glance
- Drugs Ketamine (Primary)
- Indications Major depressive disorder
- Focus Proof of concept; Therapeutic Use
- Acronyms BEDROC
- Sponsors Douglas Pharmaceuticals
- 18 Oct 2022 Results presented at the 35th Annual Congress of the European College of Neuropsychopharmacology
- 18 Oct 2022 Results assessing the efficacy of of new extended release oral ketamine for treatment resistant depression presented at the 35th Annual Congress of the European College of Neuropsychopharmacology
- 16 Dec 2021 Primary endpoint has been met. (To evaluate the efficacy of extended release (ER) R-107 tablets (30mg, 60mg, 120mg, 180mg) as measured by the change in Montgomery-Asberg Depression Rating Scale (MADRS) score from baseline (Day 1) to Day 92 in subjects with Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) Treatment-Resistant Depression (TRD) who have responded to 1 weeks treatment with R-107 120mg...), according to a Douglas Pharmaceuticals Media Release.