TerminatedPhase 3

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

Stopped: internal company decision

United States87 participantsStarted 2019-02-04

Plain-language 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 disorder (MDD) and insomnia.

Who can participate

Age range18 Years – 64 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

Average Change From Baseline in Sleep Efficiency (SE) as Assessed by Polysomnogram (PSG) at Days 13 and 14

Timeframe: Baseline and Days 13, 14

Trial details

NCT IDNCT03771664

SponsorBiogen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-12-20

Results submitted2022-08-31

View on ClinicalTrials.gov More Major Depressive Disorder trials