A Study of Seltorexant Compared to Quetiapine XR as Adjunctive Therapy to Antidepressants in Adult and Elderly Participants With Major Depressive Disorder With Insomnia Symptoms Who Have Responded Inadequately to Antidepressant Therapy
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Janssen Research & Development, LLC
- Study ID
- NCT04513912
- Phase
- PHASE3
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 74 Years
- Healthy Volunteers
- Not accepted
Interventions
- Seltorexant — DRUGParticipants will receive seltorexant over-encapsulated tablet orally.
- Matching placebo to Seltorexant — DRUGParticipants will receive placebo over-encapsulated tablet matching to seltorexant orally.
- Quetiapine XR — DRUGParticipants will receive quetiapine XR capsule orally.
- Matching placebo to Quetiapine XR — DRUGParticipants will receive placebo capsule matching to quetiapine XR orally.
Study Details
The purpose of this study is to assess the efficacy of seltorexant compared with quetiapine extended-release (XR) as adjunctive therapy to an antidepressant drug in treatment response in participants with major depressive disorder with insomnia symptoms (MDDIS) who have had an inadequate response to current antidepressant therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI).
Key Dates
- Start date
- Sep 15, 2020
- Status verified
- Aug 2025
- Primary completion
- Oct 3, 2023
- Completion
- Oct 3, 2023
Study Design
- Enrollment
- 757 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: SeltorexantAdult participants will receive seltorexant once daily from Day 1-7 and together with matching placebo from Day 8 till Day 182. Elderly participants will receive seltorexant once daily from Day 1-3 and together with matching placebo from Day 4 till Day 182.
- Active Comparator: Quetiapine Extended-Release (XR)Adult participants will receive quetiapine XR once daily from Day 1-2, followed by an increase in dose from Day 3-7, and from Day 8-14 together with matching placebo. After Day 14, quetiapine XR twice daily from Day 14 till Day 182. Elderly participants will receive quetiapine XR once daily from Day 1-3 and twice from Day 4-7, followed by an increase in dose once daily from Day 8-14 together with matching placebo. After Day 14 till Day 182, quetiapine XR will be adjusted by investigator based on the participant's clinical response and tolerability.
Primary Outcome Measure
Percentage of Participants with Response (>=50 Percent improvement in MADRS total score from baseline) at Week 26 [ Time Frame: Week 26 ]
Locations (75)
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