A Study to Evaluate the Efficacy of Sage-217 in the Treatment of Adult Participants With Major Depressive Disorder (MDD)

  • STATUS
    Recruiting
  • participants needed
    240
  • sponsor
    Sage Therapeutics
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Updated on 16 February 2024
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antidepressants
depressive disorder
psychotherapy
psychiatric disorder
scid
structured clinical interview
benzodiazepines
depression
major depressive disorder
anxiolytics

Summary

The purpose of this study to evaluate the efficacy of SAGE-217 in the treatment of participants with MDD.

Details
Condition Major depression
Age 18years - 64years
Treatment Placebo, SAGE-217
Clinical Study IdentifierNCT04442490
SponsorSage Therapeutics
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Participant with diagnosis of MDD as diagnosed by Structured Clinical Interview for Diagnostic and Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Clinical Trial Version [SCID-5-CT], with symptoms that have been present for at least a 4-week period
Participant has a Hamilton Rating Scale for Depression (HAM-D) total score 24 at screening and Day 1 (prior to dosing)
Participants taking antidepressants must have been taking these medications at the same dose for at least 60 days prior to Day 1. Participants who have stopped taking antidepressants within 60 days must have stopped for longer than 5 half-lives of the antidepressant prior to Day 1. Participants receiving psychotherapy must have been receiving therapy on a regular schedule for at least 60 days prior to Day 1
Participant is willing to delay start of other antidepressant or antianxiety medications and any new pharmacotherapy regimens, including as-needed benzodiazepine anxiolytics and sleep aids, until after completion of the Day 42 visit

Exclusion Criteria

Participant is currently at significant risk of suicide, as judged by the Investigator, or has attempted suicide associated with the current episode of MDD
Participant has 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 a body mass index (BMI) 18 or 45 kg/m^2 at Screening, which is subject to a broader evaluation of medical comorbidities
Participant has treatment-resistant depression, defined as persistent depressive symptoms despite treatment with adequate doses of antidepressants within the current major depressive episode (excluding antipsychotics) from two different classes for at least 4 weeks of treatment
Participant has a medical history of seizures, bipolar disorder, schizophrenia, and/or schizoaffective disorder
Participant has a history of mild, moderate, or severe substance use disorder (including benzodiazepines) diagnosed using DSM-5 criteria in the 12 months prior to screening
Participant is taking psychostimulants (eg, methylphenidate, amphetamine) or opioids, regularly or as-needed, at Day -28
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antidepressants
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anxiolytics

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