Phase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major

Phase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major Depressive Disorder and Insomnia Symptoms

Last Updated February 19, 2025

Want to learn how to participate in this trial?

42847922MDD3003

OVERVIEW

Sexes Eligible for Study
all
Age
18+ years
Phase
phase 3

3
Sites
13 Sites
Status

Recruiting

SUMMARY

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).

CONDITIONS

Depressive Disorder, Major

ELIGIBILITY

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

Inclusion Criteria:

Participants in part 1 and direct enrollers to part 2:

More...

DETAILS

LOCATIONS

Locations in:

United States

Country (1)	City or Province (13)	Status
United States	Little Rock Preferred Research Partners	RECRUITING
United States	Oceanside Excell Research Inc	RECRUITING
United States	Rancho Cucamonga Prospective Research Innovations Inc	RECRUITING
United States	Redlands Anderson Clinical Research	RECRUITING
United States	Sherman Oaks California Neuroscience Research	RECRUITING
United States	Denver Mountain View Clinical Research	RECRUITING
United States	Homestead Advanced Research Institute of Miami	RECRUITING
United States	Naperville Baber Research Group	RECRUITING
United States	Brooklyn SPRI Clinical Trials, LLC	RECRUITING
United States	Avon Lake Haidar Almhana Nieding	RECRUITING
United States	Austin BioBehavioral Research of Austin PC	RECRUITING
United States	Houston DM Clinical Research	RECRUITING
United States	Wichita Falls Grayline Research Center	RECRUITING

Geo Locations

34.74648, -92.28959

33.19587, -117.37948

34.1064, -117.59311

34.05557, -117.18254

34.15112, -118.44925

39.73915, -104.9847

25.46872, -80.47756

41.78586, -88.14729

40.6501, -73.94958

41.50532, -82.0282

30.26715, -97.74306

29.76328, -95.36327

33.91371, -98.49339

Indicates 50+ sites in this region: click to zoom in.

Indicates 10+ sites in this region: click to zoom in.

Indicates < 10 sites in this region: click to zoom in.

Corresponds to individual site.

Our Stories List