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 March 29, 2025

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42847922MDD3003

OVERVIEW

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

3
Sites
79 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, Argentina, Brazil, Türkiye

Country (4)	City or Province (79)	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
United States	Birmingham University of Alabama at Birmingham	RECRUITING
United States	Chandler Chandler Clinical Trials	RECRUITING
United States	Bryant SanRo Clinical Research Group LLC WCG Clinical Network	RECRUITING
United States	Colton Axiom Research	RECRUITING
United States	Encino Elite Research Network	RECRUITING
United States	Los Alamitos WR PRI Los Alamitos	RECRUITING
United States	Santa Ana Syrentis Clinical Research	RECRUITING
United States	Farmington UConn Health Center	RECRUITING
United States	Brandon Clinical Research of Brandon	RECRUITING
United States	Hialeah AGA Clinical Trials	RECRUITING
United States	Hialeah Reliable Clinical Research	RECRUITING
United States	Jacksonville Clinical NeuroScience Solutions Inc	RECRUITING
United States	Lake City Multi Specialty Research Associates Inc	RECRUITING
United States	Largo Alcanza Clinical Research	RECRUITING
United States	Miami Pharmax Research Clinic Inc	RECRUITING
United States	Miami Miami Dade Medical Research Institute	RECRUITING
United States	Miami Nuovida Research Center	RECRUITING
United States	Naples Aqualane Clinical Research	RECRUITING
United States	North Bay Village Bravo Health Care Center	RECRUITING
United States	Orlando Nova Psychiatry INC	RECRUITING
United States	Saint Augustine Florida Center for TMS	RECRUITING
United States	Tampa Psych Me Medical Research Inc	RECRUITING
United States	West Palm Beach Health Synergy Clinical Research	RECRUITING
United States	Winter Park Conquest Research	RECRUITING
United States	Atlanta Advanced Discovery Research	RECRUITING
United States	Atlanta Agile Clinical Research Trials, LLC	RECRUITING
United States	Decatur iResearch Atlanta LLC	RECRUITING
United States	Dunwoody Peachford Hospital-Atlanta Behavorial Research	RECRUITING
United States	Peachtree Corners Accelerated Clinical Research Group LLC	RECRUITING
United States	Savannah iResearch Savannah	RECRUITING
United States	Snellville Renew Health Clinical Research	RECRUITING
United States	Elgin Revive Research Institute	RECRUITING
United States	Boston Boston Clinical Trials	RECRUITING
United States	Watertown Adams Clinical LLC	RECRUITING
United States	Mankato Mankato Clinic	RECRUITING
United States	Las Vegas Oasis Clinical Research LLC	RECRUITING
United States	Portsmouth ActivMed Practices and Research	RECRUITING
United States	Buffalo University at Buffalo Psychiatry	RECRUITING
United States	New York Hapworth Psychiatric Medical PLLC	RECRUITING
United States	Woodbury Lucian Miron Manu MD Psychiatry PC	RECRUITING
United States	Cincinnati University of Cincinnati College of Medicine	RECRUITING
United States	Middleburg Heights North Star Medical Research	RECRUITING
United States	Philadelphia University of Pennsylvania	RECRUITING
United States	Charleston Clinical Trials of South Carolina	RECRUITING
United States	Charleston Medical University of South Carolina	RECRUITING
United States	Bellaire Houston Clinical Trials LLC	RECRUITING
United States	Fort Worth North Texas Clinical Trials	RECRUITING
United States	Stafford R and H Clinical Research	RECRUITING
United States	Draper Cedar Clinical Research	RECRUITING
United States	Everett Core Clinical Research	RECRUITING
Argentina	Ciudad Autonoma de Buenos Aires Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales	RECRUITING
Argentina	Cordoba CEN Consultorios Especializados en Neurociencias	RECRUITING
Argentina	Cordoba Instituto Medico DAMIC	RECRUITING
Argentina	Cordoba Centro Medico Luquez	RECRUITING
Argentina	Cordoba Sanatorio Prof Leon S Morra S A	RECRUITING
Argentina	La Plata INSA Instituto de Neurociencias San Agustín	RECRUITING
Argentina	Rosario C I A P Centro de investigacion y Asistencia en Psiquiatria	RECRUITING
Argentina	Santiago del Estero Clinica El Jardin	RECRUITING
Brazil	Brasilia L2IP Instituto de Pesquisas Clinicas	RECRUITING
Brazil	Criciuma Sociedade Literaria e Caritativa Santo Agostinho Hospital Sao Jose	RECRUITING
Brazil	Natal Universidade Federal do Rio Grande do Norte Hospital Universitario Onofre Lopes	RECRUITING
Brazil	Porto Alegre Hospital De Clinicas De Porto Alegre	RECRUITING
Brazil	Rio de Janeiro Ruschel Medicina e Pesquisa Clínica Ltda	RECRUITING
Brazil	Sao Bernardo do Campo Centro Integrado Facili	RECRUITING
Brazil	Sao Paulo CPQuali Pesquisa Clinica LTDA ME	RECRUITING
Türkiye	Bursa Uludag Universitesi Tıp Fakultesi Hastanesi	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

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30.26715, -97.74306

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33.91371, -98.49339

33.52066, -86.80249

33.30616, -111.84125

34.59593, -92.48905

34.0739, -117.31365

34.15917, -118.50119

33.80307, -118.07256

33.74557, -117.86783

41.71982, -72.83204

27.9378, -82.28592

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47.97898, -122.20208

-34.61315, -58.37723

-31.4135, -64.18105

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40.19559, 29.06013

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.

OVERVIEW

Sexes Eligible for Study

Age

Phase

Sites

Status

SUMMARY

CONDITIONS

ELIGIBILITY

DETAILS

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

33.52066, -86.80249

33.30616, -111.84125

34.59593, -92.48905

34.0739, -117.31365

34.15917, -118.50119

33.80307, -118.07256

33.74557, -117.86783

41.71982, -72.83204

27.9378, -82.28592

25.8576, -80.27811

25.8576, -80.27811

30.33218, -81.65565

30.18968, -82.63929

27.90979, -82.78842

25.77427, -80.19366

25.77427, -80.19366

25.77427, -80.19366

26.14234, -81.79596

25.84621, -80.15394

28.53834, -81.37924

29.89469, -81.31452

27.94752, -82.45843

26.71534, -80.05337

28.6, -81.33924

33.749, -84.38798

33.749, -84.38798

33.77483, -84.29631

33.94621, -84.33465

33.9701, -84.22159

32.08354, -81.09983

33.85733, -84.01991

42.03725, -88.28119

42.35843, -71.05977

42.37093, -71.18283

44.15906, -94.00915

36.17497, -115.13722

43.07176, -70.76255

42.88645, -78.87837

40.71427, -74.00597

41.36454, -74.10598

39.12713, -84.51435

41.36144, -81.81291

39.95233, -75.16379

32.77657, -79.93092

32.77657, -79.93092

29.70579, -95.45883

32.72541, -97.32085

29.61607, -95.55772

40.52467, -111.86382

47.97898, -122.20208

-34.61315, -58.37723

-31.4135, -64.18105

-31.4135, -64.18105

-31.4135, -64.18105

-31.4135, -64.18105

-34.92145, -57.95453