A Study to Evaluate the Efficacy and Safety of JNJ-42847922 as Adjunctive Therapy to Antidepressants in Adult Participants With Major Depressive Disorder Who Have Responded Inadequately to Antidepressant Therapy

NCT03227224 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: CR10828142847922MDD20012015-005282-22
• Study Type: interventional
• Target: 287
• Locations: 8 countries
• Sites: 101

Brief Summary

The purpose of this study is to assess the dose-response relationship of 2 doses of JNJ-42847922 before interim analysis, and potentially 3 doses based on interim analysis results, compared to placebo as adjunctive therapy to an antidepressant drug in improving depressive symptoms in participants with Major Depressive Disorder (MDD) who have had an inadequate response to current antidepressant therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI); and to assess the safety and tolerability of JNJ-42847922 compared to placebo as adjunctive therapy to an antidepressant in participants with MDD.

Conditions

Depressive Disorder, Major

Outcome Measures

Primary Outcomes (23)

• Change From Baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

  MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The MADRS evaluates the following 10 items: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score range of 0-60 which is calculated by adding the scores of all 10 items. Higher scores represent a more severe condition.

  Baseline to Week 6

• Percentage of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability

  An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between the initial administration of study drug and 2 days after the last administration of study drug.

  Up to Week 8

• Percentage of Participants With Clinically Significant Laboratory Abnormalities

  Percentage of participants with clinically significant laboratory abnormalities were reported which included Gamma-glutamyl transferase (GGT), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), Creatine Kinase (CK), Lactate Dehydrogenase (LDH), Albumin , bicarbonate, bilirubin, calcium, chloride, cholesterol, creatinine, direct bilirubin, glucose, high density lipoprotein (HDL) cholesterol, hemoglobin A1C, low density lipoprotein (LDL) cholesterol, phosphate, potassium, protein, sodium, triglycerides, urate, and urea nitrogen.

  Up to Week 8

• Change From Baseline in Vital Signs (Systolic Blood Pressure [SBP] and Diastolic Blood Pressure [DBP]) at Day 8

  Change from baseline in vital signs (SBP and DBP) at Day 8 was reported.

  Baseline and Day 8

• Change From Baseline in Vital Signs (SBP and DBP) at Day 22

  Change from baseline in vital signs (SBP and DBP) at Day 22 was reported.

  Baseline and Day 22

• Change From Baseline in Vital Signs (SBP and DBP) at Day 42

  Change from baseline in vital signs (SBP and DBP) at Day 42 was reported.

  Baseline and Day 42

• Change From Baseline in Vital Signs (SBP and DBP) at Endpoint (Week 6)

  Change from baseline in vital signs (SBP and DBP) at endpoint was reported.

  Baseline and Endpoint (Week 6)

• Change From Baseline in Vital Sign (Pulse Rate [PR]) at Day 8

  Change from baseline in vital sign (PR) at Day 8 was reported.

  Baseline and Day 8

• Change From Baseline in Vital Sign (PR) at Day 22

  Change from baseline in vital sign (PR) at Day 22 was reported.

  Baseline and Day 22

• Change From Baseline in Vital Sign (PR) at Day 42

  Change from baseline in vital sign (PR) at Day 42 was reported.

  Baseline and Day 42

• Change From Baseline in Vital Sign (PR) at Endpoint (Week 6)

  Change from baseline in vital sign (PR) at endpoint (Week 6) was reported.

  Baseline and Endpoint (Week 6)

• Change From Baseline in Vital Sign (Temperature) at Day 8

  Change from baseline in vital Sign (temperature) at Day 8 was reported.

  Baseline and Day 8

• Change From Baseline in Vital Sign (Temperature) at Day 22

  Change from baseline in vital Sign (temperature) at Day 22 was reported.

  Baseline and Day 22

• Change From Baseline in Vital Sign (Temperature) at Day 42

  Change from baseline in vital Sign (temperature) at Day 42 was reported.

  Baseline and Day 42

• Change From Baseline in Vital Sign (Temperature) at Endpoint (Week 6)

  Change from baseline in vital Sign (temperature) at endpoint (Week 6) was reported.

  Baseline and Endpoint (Week 6)

• Change From Baseline in Physical Examination (Waist Circumference) at Day 42

  Change from baseline in physical examination (waist circumference) was reported.

  Baseline and Day 42

• Change From Baseline in Physical Examination (Body Weight) at Day 42

  Change from baseline in physical examination (body weight) was reported.

  Baseline and Day 42

• Change From Baseline in Physical Examination (Body Mass Index [BMI]) at Day 42

  Change from baseline in physical examination (BMI) was reported.

  Baseline and Day 42

• Percentage of Participants With Treatment-emergent Abnormal Electrocardiogram (ECG) Values Outside Pre-defined Limits

  Percentage of participants with treatment-emergent abnormal ECG values (Heart rate less than or equal to \[\<=\] 50 or greater than or equal to \[\>=\] 100 beats per minute \[bpm\], PR interval \<=120 or \>=200 milliseconds \[msec\], QRS interval \<=60 or \>=120 msec, and QT interval \<=200 or \>=500 msec) outside pre-defined limits were reported.

  Up to Week 6

• Percentage of Participants With Most Severe Post-baseline Potentially Suicide-Related Category Using Columbia Suicide Severity Rating Scale (C-SSRS)

  C-SSRS is a clinician-rated instrument that reports severity of both suicidal ideation and behavior. Suicidal ideation was classified on a 5-item scale: 1 (wish to be dead), 2 (nonspecific active suicidal thoughts), 3 (active suicidal ideation with any methods \[not plan\] without intent to act), 4 (active suicidal ideation with some intent to act, without specific plan), and 5 (active suicidal ideation with specific plan and intent). Suicidal behavior is classified on a 5-item scale: 0 (no suicidal behavior), 1 (preparatory acts or behavior), 2 (aborted attempt), 3 (interrupted attempt), and 4 (actual attempt). More than 1 classification can be selected provided they represent separate episodes. Minimum total score 0, maximum total score 5; higher total scores indicate more suicidal ideation and/or suicidal behavior. If no events qualify for score of 1 to 10, score of 0 was assigned (0= "no event that can be assessed on the basis of C-SSRS"). Higher scores indicate greater severity.

  Up to Week 8

• Change From Baseline in Sexual Functioning as Measured by Arizona Sexual Experiences Scale (ASEX) Score at Day 42

  Effect on sexual functioning was assessed using the ASEX score. The ASEX is a five-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Each of the 5 items is rated on a 6-point scale, ranging from 1 to 6. The 5 items are summed to create a total score, ranging from 5 to 30, with the higher scores indicating more sexual dysfunction.

  Baseline and Day 42

• Physician Withdrawal Checklist-20 (PWC-20) Total Score at Day 43

  Intensity of discontinuation symptoms was assessed (for example: underlying depression; anxiety-nervousness; dysphoric mood/depression; difficulty concentrating; weakness; fatigue-lethargy-lack of energy; irritability), using the Physician Withdrawal Checklist (PWC-20) administered by a trained clinician/rater. Symptoms are rated on a scale 0 (No symptom present) and 3 (severe symptoms). Total scores range from 0 to 24 calculated by adding the scores of following 8 items: Nausea-Vomiting, Diarrhea, Poor Coordination, Diaphoresis, Tremor-Tremulousness, Dizziness-Lightheadedness, Increased Acuity Sound Smell Touch, Paresthesias. Higher scores indicating more severe symptoms.

  Day 43

• Physician Withdrawal Checklist-20 (PWC-20) Total Score From Day 49 to Day 56

  Intensity of discontinuation symptoms was assessed (for example: underlying depression; anxiety-nervousness; dysphoric mood/depression; difficulty concentrating; weakness; fatigue-lethargy-lack of energy; irritability), using the Physician Withdrawal Checklist (PWC-20) administered by a trained clinician/rater. Symptoms are rated on a scale 0 (No symptom present) and 3 (severe symptoms). Total scores range from 0 to 24 calculated by adding the scores of following 8 items: Nausea-Vomiting, Diarrhea, Poor Coordination, Diaphoresis, Tremor-Tremulousness, Dizziness-Lightheadedness, Increased Acuity Sound Smell Touch, Paresthesias. Higher scores indicating more severe symptoms.

  Day 49 to Day 56

Secondary Outcomes (19)

• Change From Baseline in the MADRS Total Score by Baseline Insomnia Severity Index (ISI) Score at Day 42

  Baseline and Day 42

• Change From Baseline in ISI Total Score at DB Endpoint (Up to Week 6)

  Baseline and DB Endpoint (Up to Week 6)

• Percentage of Participants With Response on Depressive Symptoms Scale Based on MADRS Total Score

  Day 42

• Percentage of Participants With Remission of Depressive Symptoms Based on MADRS Total Score

  Day 42

• Change From Baseline in Structured Interview Guide for the Hamilton Anxiety Rating Scale (HAM-A) Total Score at Day 42

  Baseline and Day 42

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Participants will receive 2 placebo capsules matching JNJ-42847922 once daily orally from Day 1 to Day 41 (Week 6).

Drug: Placebo

JNJ-42847922

EXPERIMENTAL

Participants will receive 2 capsules of JNJ-42847922 once daily orally from Day 1 to Day 41 (Week 6).

Drug: JNJ-42847922

Interventions

Placebo DRUG

Participants will receive 2 placebo capsules matching JNJ-42847922 once daily orally from Day 1 to Day 41 (Week 6).

Placebo

JNJ-42847922 DRUG

Participants will receive 2 capsules of JNJ-42847922 once daily orally from Day 1 to Day 41 (Week 6).

Also known as: MIN-202;, Seltorexant

JNJ-42847922

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women of non-childbearing potential (WONCBP), aged 18 to 70 years (inclusive). A WONCBP is defined as: a).Postmenopausal: A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. b). Permanently sterile: Permanent sterilization methods include hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures, and bilateral oophorectomy. c). If reproductive status is questionable, additional evaluation should be considered
• Meet Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-5) diagnostic criteria for major depressive disorder (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). In addition their major depressive episode must be deemed "valid" using the SCID Screening Questionnaire (SSQ) interview administered by remote, independent raters. The length of the current depressive episode must be less than or equal to (\<=) 18 months
• Have had an inadequate response to at least 1 but no more than 3 antidepressants, administered at an adequate dose and duration in the current episode of depression, as measured by the Massachusetts General Hospital-Antidepressant Treatment Response Questionnaire (MGH-ATRQ). An inadequate response is defined as less than (\<)50 percent (%) reduction in depressive symptom severity, as assessed by the MGH-ATRQ. An adequate trial is defined as an antidepressant treatment for at least 4 weeks at or above the minimum therapeutic dose specified in the MGH-ATRQ, for any particular antidepressant. The inadequate response must include the participant's current antidepressant treatment
• Participants receiving monotherapy treatment for depressive symptoms with one of the following selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) antidepressants, in any formulation: citalopram, duloxetine, escitalopram, fluvoxamine, fluoxetine, milnacipran, levomilnacipran, paroxetine, sertraline, venlafaxine, desvenlafaxine, vilazodone, or vortioxetine at a stable dose (at or above the minimum therapeutic dose level) for at least 4 weeks, and for no greater than 12 months, at screening. Modification of an effective preexisting therapy should not be made for the explicit purpose of entering a subject into the study
• Have a Montgomery-Asberg Depression Rating Scale (MADRS) total score greater than or equal to (\>=)25 (performed by independent, centralized remote raters) at screening and must not demonstrate a clinically significant improvement (that is, an improvement of greater than \[\>\]20% on their MADRS total score) from the screening to baseline visit
• Must be otherwise healthy on the basis of physical examination, medical history, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests performed at screening. If the results of the clinical laboratory tests are outside the normal reference ranges, the participant could be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator

You may not qualify if:

• Has a history of, or current signs and symptoms of, severe renal insufficiency (creatinine clearance \<30 milliliter per minute \[mL/min\]); moderate to severe hepatic insufficiency (Child-Pugh Score 7-9), significant or unstable cardiovascular, respiratory, gastrointestinal, neurologic (including narcolepsy), hematologic, rheumatologic, immunologic or endocrine disorders (including uncontrolled hypo- or hyperthyroidism or diabetes, or insulin-dependent diabetes mellitus). Participants with non-insulin dependent diabetes mellitus who are well-controlled (hemoglobin A1C \[HbA1C\] \<=7.5% and fasting glucose \<126 milligram per deciliter \[mg/dL\] at screening) could be eligible to participate if otherwise medically healthy, and if on a stable regimen of glucose-lowering medications for at least 2 months prior to screening
• Has signs and symptoms of Cushing's Disease, Addison's Disease, primary amenorrhea, or other evidence of significant medical disorders of the hypothalamic-pituitary-adrenal (HPA) axis
• Has a history of lack of response to 3 or more adequate antidepressant treatments, as indicated by no or minimal (\<= 25% improvement in symptoms) when treated with an antidepressant of adequate dose (per MGH-ATRQ) and duration (at least 4 weeks)
• Has history or current diagnosis of a psychotic disorder, bipolar disorder, mental retardation, autism spectrum disorder, or borderline personality disorder, somatoform disorders, chronic fatigue syndrome or fibromyalgia
• Has any significant primary sleep disorder, including but not limited to obstructive sleep apnea, restless leg syndrome, or parasomnias

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (101)

California Pharmaceutical Research Institute, Inc.

Anaheim, California, 92804, United States

Location

Catalina Research Institute

Chino, California, 91710, United States

Location

Synergy Clinical Research Center Of Escondido

Lemon Grove, California, 91945, United States

Location

Asclepes Research

Panorama City, California, 91402, United States

Location

Sharp Mesa Vista Hospital

San Diego, California, 92123, United States

Location

SF-Care, Inc

San Rafael, California, 94901, United States

Location

Collaborative NeuroScience Network

Torrance, California, 90502, United States

Location

Elite Clinical Trials

Wildomar, California, 92595-7007, United States

Location

Sarkis Clinical Trials

Gainesville, Florida, 32607, United States

Location

Velocity Clinical Research, Hallandale Beach

Hallandale, Florida, 33009, United States

Location

Clinical NeuroScience Solutions Inc

Jacksonville, Florida, 32256, United States

Location

Innovative Clinical Research Inc

Lauderhill, Florida, 33319, United States

Location

Qps-Mra, Llc

Miami, Florida, 33143, United States

Location

Galiz Research

Miami Springs, Florida, 33166, United States

Location

Behavioral Clinical Research , Inc

North Miami, Florida, 33162, United States

Location

Clinical NeuroScience Solutions Inc

Orlando, Florida, 32801, United States

Location

Compass Research LLC

Orlando, Florida, 32806, United States

Location

Emory University

Atlanta, Georgia, 30022, United States

Location

Radiant Research, Inc.

Atlanta, Georgia, 30328, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

Location

NeuroTrials Research, Inc.

Atlanta, Georgia, 30342, United States

Location

Chicago Research Center

Chicago, Illinois, 60634, United States

Location

Great Lakes Clinical Trials

Chicago, Illinois, 60640, United States

Location

Joliet Center for Clinical Research

Joliet, Illinois, 60435, United States

Location

Clinilabs

New York, New York, 10019, United States

Location

Richmond Behavioral Associates

Staten Island, New York, 10312, United States

Location

Clinical Trials of America

Winston-Salem, North Carolina, 27103, United States

Location

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Neuro Behavioral Clinical Research

Canton, Ohio, 44708, United States

Location

Midwest Clinical Research Center

Dayton, Ohio, 45417, United States

Location

Suburban Research Associates

Media, Pennsylvania, 19063, United States

Location

Family Psychiatry of The Woodlands

The Woodlands, Texas, 77381, United States

Location

Core Clinical Research

Everett, Washington, 98201, United States

Location

Mental Health Center Prof. Dr. Ivan Temkov

Burgas, 8000, Bulgaria

Location

State Psychiatric Hospital Kardzhali

Kardzhali, 6600, Bulgaria

Location

State Psychiatric Hospital - Lovech

Lovech, 5500, Bulgaria

Location

UMHAT 'Dr. Georgi Stranski', EAD

Pleven, 5800, Bulgaria

Location

MC 'Hipokrat - N', EOOD

Plovdiv, 4002, Bulgaria

Location

Mental Health Center - Rousse

Rousse, 7003, Bulgaria

Location

MHC - Sofia, EOOD

Sofia, 1202, Bulgaria

Location

University Multiprofile Hospital for Active Treatment - UMHAT Alexandrovska EAD

Sofia, 1431, Bulgaria

Location

Medical Center 'Doverie'

Sofia, 1632, Bulgaria

Location

Medical Center Intermedica, OOD

Sofia, 1680, Bulgaria

Location

MHAT-Targovishte, AD

Targovishte, 7700, Bulgaria

Location

State Psychiatric Hospital - Tzarev Brod

Tzarev Brod, 9747, Bulgaria

Location

Diagnostic Consulting Center Mladost - M Varna

Varna, 9020, Bulgaria

Location

Mental Health Center - Veliko Tarnovo EOOD

Veliko Tarnovo, 5000, Bulgaria

Location

Mederon Oy

Helsinki, 00100, Finland

Location

Savon Psykiatripalvelu

Kuopio, 70110, Finland

Location

Oulu Mentalcare Oy

Oulu, 90100, Finland

Location

Satakunnan Psykiatripalvelu

Rauma, 26100, Finland

Location

CHU Clermont-Ferrand - Hopital Gabriel Montpied

Clermont-Ferrand, 63000, France

Location

Cabinet Medical des Drs Prizac-Desbonnet Scottez

Douai, 59500, France

Location

CHU Nimes Hopital Caremeau

Nîmes, 30029, France

Location

Hopital Sainte Anne

Paris, 75674, France

Location

Centre Hospitalier Guillaume Regnier

Rennes, 35011, France

Location

Neurologische Praxis Dr. Schoell & Kollegen

Bad Homburg, 61348, Germany

Location

Klinikum Chemnitz gGmbH

Chemnitz, 09131, Germany

Location

Universitatsklinikum Carl Gustav Carcus Dresden

Dresden, 01307, Germany

Location

Somni Bene GmbH

Schwerin, 19053, Germany

Location

Hongo Todaimae Mental Clinic

Bunkyō City, 113-0033, Japan

Location

Kuramitsu Hospital

Fukuoka, 819-0037, Japan

Location

National Center for Global Health and Medicine Kohnodai hospital

Ichikawa-shi, 272-8516, Japan

Location

National Hospital Organization Hizen Psychiatric Center

Kanzaki-gun, 842-0192, Japan

Location

Nara Medical University Hospital

Kashihara-shi, 634-8522, Japan

Location

Senzoku Mental Clinic

Meguro-ku, 152-0012, Japan

Location

Heart Care Ginga Clinic

Nakano, 164-0012, Japan

Location

Shiranui Hospital

Omuta-shi, 836-0004, Japan

Location

Seiwakai Yutaka Clinic

Sagamihara-shi, 252-0303, Japan

Location

Sangenjaya Nakamura Mental Clinic

Setagaya-ku, 154-0004, Japan

Location

Yoyogi Mental Clinic

Shibuya-ku, 151-0051, Japan

Location

Etoh Mental Clinic

Shinagawa-ku, 141-0021, Japan

Location

Nishi-Shinjuku Concieria Clinic

Shinjuku-ku, 160-0023, Japan

Location

Tamaki Clinic

Shinjuku-ku, 160-0023, Japan

Location

Shinjuku Research Park Clinic

Shinjuku-ku, 169-0073, Japan

Location

Ohwa Mental Clinic

Toshima-ku, 170-0002, Japan

Location

Sekino Hospital

Toshima-ku, 171-0014, Japan

Location

Jisenkai Hozumi Himorogi Clinic

Toshima-ku, 171-0022, Japan

Location

SHI Arkhangelsk Regional Clinical Psychiatric Hospital

Arkhangelsk, 163530, Russia

Location

City Clinical Psychiatric Hopsital 3

Moscow, 107076, Russia

Location

FSI Moscow SRI of Psychiatry of Minzdravsocrazvitia

Moscow, 107076, Russia

Location

Closed corporation 'Scientific Center of Personalized Psychiatry'

Moscow, 119180, Russia

Location

First Moscow State Medical University n.a. I.M. Sechenov

Moscow, 119991, Russia

Location

Clinical Psychiatry Hospital n.a. N.N. Solodovnikov

Omsk, 644070, Russia

Location

Medical and Rehabilitation Research Center Phoenix

Rostov-on-Don, 344010, Russia

Location

City Psychiatric Hospital of St. Nikolay Chudotvorets

Saint Petersburg, 190121, Russia

Location

St-Petersburg Bekhterev Psychoneurological Research Institute

Saint Petersburg, 192019, Russia

Location

SHI 'Saratov City Clinical Hospital 2 n.a V.I. Razumovsky

Saratov, 410028, Russia

Location

Engels psychiatric hospital

Saratov Region, 413124, Russia

Location

Research Institute of Mental Health

Tomsk, 634014, Russia

Location

Sverdlov Regional Psychiatric Clinical Hospital

Yekaterinburg, 620030, Russia

Location

CNCE'Precarpathian Regional Clinical Mental Health Center Ivano-Frankivsk RC'

Ivano-Frankivsk, 76014, Ukraine

Location

Mnpe of Kharkiv Regional Council 'Regional Clinical Psychiatric Hospital #3'

Kharkiv, 61068, Ukraine

Location

Cnce 'Kyiv City Psychoneurological Hospital #2' of Executive Body of Kyiv City Council (Kcsa)

Kyiv, 2660, Ukraine

Location

CNCE of the Lviv Regional Council 'Lviv Regional Clinical Psychiatric Hospital'

Lviv, 79021, Ukraine

Location

CI Odesa Regional Medical Center of Mental Health

Odesa, 65006, Ukraine

Location

CNCE Odesa regional psychiatric hospital #2 Odesa regional council

Oleksandrivka, 67513, Ukraine

Location

Poltava O.F. Maltsev RC Psychiatric Hospital Dept #9 (Ad-P Dept) HSEIU Ukrainian MSA

Poltava, 36006, Ukraine

Location

Ternopil RCCPH Depts of Psychiatry #2 (m) & Psychiatry #4 (f) Ternopil I.Ya. Gorbachevskyi SMU

Ternopil, 46020, Ukraine

Location

CI O.I. Yuschenko VRPsH Depts #7 & #10 M.I. Pyrogov VNMU

Vinnytsia, 21005, Ukraine

Location

CNCE 'Vinnytsya RC Psychoneurological Hospital n.a. O.I. Yushchenko Vinnytsya RC'

Vinnytsia, 21005, Ukraine

Location

Related Publications (1)

• Savitz A, Wajs E, Zhang Y, Xu H, Etropolski M, Thase ME, Drevets WC. Efficacy and Safety of Seltorexant as Adjunctive Therapy in Major Depressive Disorder: A Phase 2b, Randomized, Placebo-Controlled, Adaptive Dose-Finding Study. Int J Neuropsychopharmacol. 2021 Dec 8;24(12):965-976. doi: 10.1093/ijnp/pyab050.

  PMID: 34324636 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

seltorexant

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: SENIOR DIRECTOR
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2017
• First Posted: July 24, 2017
• Study Start: August 16, 2017
• Primary Completion: January 12, 2019
• Study Completion: January 19, 2019
• Last Updated: April 29, 2025
• Results First Posted: February 7, 2022

Record last verified: 2025-04

Locations

US (33); RU (13); FR (5); DE (4); UA (10); JP (18); BU (14); FI (4)