A study to Evaluate SAGE-217 for the Treatment of Adults with Post-Partum Depressio

Phase 1

• Conditions: POSTPARTUM DEPRESSION; MedDRA version: 20.0Level: LLTClassification code 10056393Term: Postpartum depressionSystem Organ Class: 100000004873; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2020-001424-34-GB
• Lead Sponsor: Sage Therapeutics, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-19
• Last Update Posted: 7 December 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 192

Inclusion Criteria

-Participant has ceased lactating or agrees not to provide breastmilk to her infant(s) from just prior to receiving the investigational product (IP) on Day 1 until 7 days after the last dose of IP.
-Participant has had a major depressive episode that began no earlier than the third trimester and no later than the first 4 weeks following delivery, as diagnosed by Structured Clinical Interview for Diagnostic and DSM-5 Clinical Trial Version (SCID-5-CT).
-Participant is =6 months postpartum

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 192
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Participant is at significant risk of suicide or has attempted suicide associated with the current episode of PPD.
-Participant has active psychosis per investigator assessment.
-Participant has a medical history of nonfebrile seizures.
-Participant has a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.
-Participant has a history of sleep apnea.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine if treatment with SAGE-217 reduces depressive symptoms in adults with severe postpartum depression (PPD) compared to placebo;Secondary Objective: To determine if treatment with SAGE-217 reduces anxiety symptoms compared to placebo<br>To assess self-report of depressive symptoms<br>To evaluate the safety and tolerability of SAGE-217 <br>;Primary end point(s): Change from baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D) total score;Timepoint(s) of evaluation of this end point: At Day 15