Status:
COMPLETED
A Comparative Study of Sage-217 Plus an Antidepressant (ADT) Versus Placebo Plus an ADT in Adults With Major Depressive Disorder
Lead Sponsor:
Biogen
Conditions:
Depressive Disorder, Major
Eligibility:
All Genders
18-64 years
Phase:
PHASE3
Brief Summary
The primary purpose of this study is to evaluate the efficacy of SAGE-217 plus an ADT in the treatment of major depressive disorder (MDD) compared to placebo plus an ADT.
Detailed Description
This study was previously posted by Sage Therapeutics. In November 2023, sponsorship of the trial was transferred to Biogen.
Eligibility Criteria
Inclusion
- Diagnosis of MDD as diagnosed by Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Clinical Trials Version (SCID-5-CT), with symptoms that have been present for at least a 4-week period
- 17-item Hamilton Rating Scale for Depression (HAM-D-17) total score of ≥24 at Screening and Day 1
- Participant in good physical health and has no clinically significant findings, as determined by the investigator, on physical examination, 12-lead electrocardiogram (ECG), or clinical laboratory tests
- Participant is willing, able, and eligible to take at least 1 of the 5 ADTs specified in the protocol (an eligible ADT is an ADT that has not been taken during the current depressive episode and for which the participant has no contraindications; further, a participant is not eligible for citalopram if escitalopram has been taken during the current depressive episode, and vice versa)
Exclusion
- Has attempted suicide associated with the current episode of MDD
- Participant had onset of the current depressive episode during pregnancy or 4 weeks postpartum, or the participant has presented for screening during the 6-month postpartum period
- Participant has treatment-resistant depression
- History of bipolar disorder, schizophrenia, and/or schizoaffective disorder
- Known allergy to SAGE-217, allopregnanolone, or related compounds
- Has taken antidepressants within 30 days prior to Day 1, and/or has taken fluoxetine within 60 days prior to Day 1
Key Trial Info
Start Date :
November 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 22 2021
Estimated Enrollment :
440 Patients enrolled
Trial Details
Trial ID
NCT04476030
Start Date
November 9 2020
End Date
December 22 2021
Last Update
December 22 2023
Active Locations (51)
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1
Sage Investigational Site
Dothan, Alabama, United States, 36303
2
Sage Investigational Site
Phoenix, Arizona, United States, 85012
3
Sage Investigational Site
Anaheim, California, United States, 92805
4
Sage Investigational Site
Costa Mesa, California, United States, 92626