Status:
TERMINATED
A Study to Evaluate the Safety, Tolerability, and Efficacy of SAGE-217 Compared to Placebo in Adult Participants With Comorbid Major Depressive Disorder (MDD) and Insomnia
Lead Sponsor:
Biogen
Conditions:
Major Depressive Disorder
Insomnia
Eligibility:
All Genders
18-64 years
Phase:
PHASE3
Brief Summary
This study is a randomized, double-blind, placebo-controlled study of the safety, tolerability, and efficacy of SAGE-217 compared to placebo in adult participants with comorbid major depressive disord...
Detailed Description
This study was previously posted by Sage Therapeutics. In November 2023, sponsorship of the trial was transferred to Biogen.
Eligibility Criteria
Inclusion
- Participant had a 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.
- Participant had a diagnosis of Insomnia that is confirmed at screening based on the diagnostic and statistical manual of mental disorders, fifth edition (DSM-5) diagnostic criteria using the SCID-5-CT.
- Participant had an Insomnia Severity Index (ISI) score greater than or equal to (\>=) 15 (moderate to severe insomnia).
- Participant had a Montgomery-Åsberg Depression Rating Scale (MADRS) score of ≥28 prior to dosing and a Hamilton Rating Scale for Depression (HAM-D) total score of ≥20.
Exclusion
- Participant had attempted suicide associated within the current episode of MDD.
- Participant had onset of the current depressive episode during pregnancy or 4 weeks postpartum, or the participant had presented for screening during the 6-month postpartum period.
- Participant had a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.
- Participant had a medical history of seizures.
- Participant had active psychosis per Investigator assessment.
Key Trial Info
Start Date :
February 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 17 2020
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT03771664
Start Date
February 4 2019
End Date
January 17 2020
Last Update
November 29 2023
Active Locations (28)
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1
Sage Investigational Site
Little Rock, Arkansas, United States, 72211
2
Sage Investigational Site
Rogers, Arkansas, United States, 72758
3
Sage Investigational Site
Garden Grove, California, United States, 92845
4
Sage Investigational Site
Oceanside, California, United States, 92056