Phase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major Depressive Disorder and Insomnia Symptoms
Purpose
The purpose of this study is to know how well seltorexant works, and also to evaluate safety and maintenance effect of seltorexant compared with placebo as an adjunctive therapy to an antidepressant in improving depressive symptoms 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).
Condition
- Depressive Disorder, Major
Eligibility
- Eligible Ages
- Between 18 Years and 74 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
Participants in part 1 and direct enrollers to part 2: - Meet DSM-5 MDD, without psychotic features based upon clinical assessment and confirmed by the structured clinical interview for DSM-5 Axis I disorders-clinical trials version (SCID-CT) diagnosed with first depressive episode prior to age 60 - Have had an inadequate response to at least 1 but no more than 2 antidepressants, administered at an adequate dose and duration in the current episode of depression. An inadequate response is defined as less than (<) 50% reduction but with some improvement (that is, improvement greater than [>] 0%) in depressive symptom severity with residual symptoms other than insomnia present, and overall good tolerability, as assessed by the MGH-ATRQ, and this must include the participant's current antidepressant treatment - Is receiving and tolerating well any one of the following SSRI or SNRI for depressive symptoms at screening, in any formulation and available in the participating country: citalopram, duloxetine, escitalopram, fluvoxamine, fluoxetine, milnacipran, levomilnacipran, paroxetine, sertraline, venlafaxine, desvenlafaxine, vilazodone, or vortioxetine at a stable dose (at therapeutic dose level) for at least 6 weeks - Having a major depressive episode of at least moderate severity, as assessed with 17-item Hamilton Depression Rating Scale, implemented through the Structured Interview Guide (SIGH-D) in a blinded manner at screening and must not demonstrate a clinically significant improvement from the beginning to end of screening. Participants entering after completing part 1: - Must have completed Part 1 DB treatment phase - Can consistently tolerate study drug (at the end of Part 1), and there is no additional safety risk for the participant if they proceed to Part 2 - Was able to consistently follow the study procedures in Part 1 as judged by the investigator. - Must be medically stable based on clinical laboratory tests
Exclusion Criteria
- Has a recent (last 3 months) history of, or current signs and symptoms of, severe renal insufficiency clinically significant or unstable cardiovascular, respiratory, gastrointestinal, neurologic, hematologic, rheumatologic, immunologic or endocrine disorders and uncontrolled Type 1 or Type 2 diabetes mellitus - Has a history of narcolepsy and seizures - Has current signs/symptoms of hypothyroidism or hyperthyroidism - Participants taking thyroid supplementation for antidepressant purposes - Has Cushing's disease, Addison's disease, primary amenorrhea, or other evidence of significant medical disorders of the HPA axis
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Part 1: Seltorexant |
Participants will receive seltorexant orally once daily for 6 weeks during the double-blind (DB) treatment phase in Part 1 of the study. Participants who do not proceed to Part 2 of the study will undergo a post-treatment follow-up phase, after the DB treatment phase in Part 1 and will continue to take their single baseline selective serotonin reuptake inhibitor (SSRI)/serotonin-norepinephrine reuptake inhibitor (SNRI) antidepressant throughout the study. |
|
|
Placebo Comparator Part 1: Placebo |
Participants will receive matching placebo orally once daily for 6 weeks during the DB treatment phase in Part 1 of the study. Participants who do not proceed to Part 2 of the study will undergo a post-treatment follow-up phase, after the DB treatment phase in Part 1 and will continue to take their single baseline SSRI/SNRI antidepressant throughout the study. |
|
|
Experimental Part 2: Open Label (OL) Seltorexant |
All participants who complete Part 1, and who meet eligibility criteria for Part 2, as well as direct entry participants, will enter Part 2 of the study. In Part 2 open-label phases (induction and stabilization) all participants (newly enrolled direct entry participants and Part 1 roll-over participants) will receive seltorexant orally in addition to their background SSRI/SNRI treatment. |
|
|
Experimental Part 2: DB Seltorexant |
All participants who complete Part 1, and who meet eligibility criteria for Part 2, as well as direct entry participants, will enter Part 2 of the study. Participants who achieve a stable response during the open-label phase will receive treatment with seltorexant orally once daily during DB Maintenance Phase in Part 2 of the study. Participants will continue to take their single baseline SSRI/SNRI antidepressant throughout the study. |
|
|
Placebo Comparator Part 2: DB Placebo |
All participants who complete Part 1, and who meet eligibility criteria for Part 2, as well as direct entry participants, will enter Part 2 of the study. Participants who achieve a stable response during the open-label phases will receive treatment with matching placebo orally once daily during DB Maintenance Phase in Part 2 of the study. Participants will continue to take their single baseline SSRI/SNRI antidepressant throughout the study. |
|
Recruiting Locations
Birmingham, Alabama 35294
Tucson, Arizona 85724
Bryant, Arkansas 72022
Anaheim, California 92801
Colton, California 92324
Oceanside, California 92056
Redlands, California 92374
San Jose, California 95124
Denver, Colorado 80209
Farmington, Connecticut 06030
Brandon, Florida 33511
Hialeah, Florida 33012
Hialeah, Florida 33012
Homestead, Florida 33033
Jacksonville, Florida 32256
Miami, Florida 33126
Miami, Florida 33176
Miami, Florida 33186
North Bay Village, Florida 33141
Orlando, Florida 32803
Tampa, Florida 33614
Tampa, Florida 33629
West Palm Beach, Florida 33407
Atlanta, Georgia 30318
Decatur, Georgia 30030
Snellville, Georgia 30078
Chicago, Illinois 60611
Chicago, Illinois 60637
Naperville, Illinois 60563
Watertown, Massachusetts 02472
Mankato, Minnesota 56001
Brooklyn, New York 11229
Brooklyn, New York 11235
Mount Kisco, New York 10549
New York, New York 10017
Cincinnati, Ohio 45215
Cincinnati, Ohio 45219
Columbus, Ohio 43210
Edmond, Oklahoma 73013
Philadelphia, Pennsylvania 19104
Charleston, South Carolina 29406
Bellaire, Texas 77401
Fort Worth, Texas 76104
Houston, Texas 77030
Houston, Texas 77081
Stafford, Texas 77477
Everett, Washington 98201
More Details
- Status
- Recruiting
- Sponsor
- Janssen Research & Development, LLC