CONTEXT: An interesting article if only for the use of a naturalistic study designed to “approximate real-world evidence” | Hmmm, so why not do a real-world study then..?
IMPACT: Medium
READ TIME: 2 mins
Quality Level Mean [1 – 10]: 7
1. “Sage Therapeutics announced 2 data sets from the ongoing phase 3 open-label SHORELINE study evaluating zuranolone: complete 12-month data from the 30 mg cohort and interim data from the 50 mg cohort.”
2. “Designed as a naturalistic study, these data approximate real-world evidence of use of zuranolone at 30 mg and 50 mg doses.”
3. “1. This clinical study was designed to evaluate the safety and tolerability of zuranolone 30 mg and 50 mg in adults for up to 1 year, and the currently analyzed data show that zuranolone was generally well-tolerated in both the 30 mg and 50 mg dose cohorts.”
4. “In the 30 mg zuranolone cohort, 725 participants with MDD were treated with a first dose of zuranolone 30 mg once nightly for 14 days.”
5. “Sage Therapeutics announces continued positive zuranolone data for both 30 mg and 50 mg doses in open-label SHORELINE study in patients with MDD.”
Source URL: https://www.psychiatrictimes.com/view/incoming-data-news-from-naturalistic-mdd-clinical-trial