2020 2021 Q3 and Q4 PII KMPT Report

Publication date:
19 July 2021
Date range:
2020 - 2021

Treatment of Adults with Severe Postpartum Depression

Quarter reported

Quarter 3

Research and Ethics Committee Reference

20/LO/1044

IRAS number

287176

Name of Trial

A Randomized, Double-Blind, Placebo-controlled Study Evaluating the Efficacy and Safety of SAGE-217 in the Treatment of Adults with Severe Postpartum Depression.

First patient recruited

No

Date of first patient recruited

Date site invited

18 June 2020

Date site selected

2 September 2020

HRA approval date

25 November 2020

Date site confirmed by sponsor

31 March 2021

Date site confirmed

31 March 2021

Date site ready to start

26 April 2021

Benchmark met

No

Reason for delay

No patients consented

Comments

Contracting delays during set-up due use of non-model commercial agreement. Challenging eligibility criteria required for study.

Reasons for delay correspond to:

Both