A Study to Compare the Efficacy, Safety, and Tolerability of JNJ-42847922 Versus Quetiapine Extended-Release as Adjunctive Therapy to Antidepressants in Adult Participants With Major Depressive Disorder Who Have Responded Inadequately to Antidepressant Therapy

NCT03321526 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: CR10839442847922MDD2002
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 50

Brief Summary

The purpose of this study is to assess the efficacy of flexibly dosed JNJ-42847922 (20 milligram \[mg\] or 40 mg) compared to flexibly dosed quetiapine extended-release (XR) (150 mg or 300 mg) as adjunctive therapy to an antidepressant drug in delaying time to all-cause discontinuation of study drug over a 6-months (24 weeks) treatment period, 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).

Conditions

Depressive Disorder, Major

Outcome Measures

Primary Outcomes (1)

• Time to All-Cause Discontinuation of Study Drug

  Time to all-cause discontinuation of study drug is defined as the number of days from the first dose of study drug to the last dose of study drug. Participants who completed double-blind treatment were not considered to have discontinued.

  Up to Week 24

Secondary Outcomes (37)

• Percentage of Participants With Sustained Remission up to Week 24

  Up to Week 24

• Percentage of Participants With Sustained Response up to Week 24

  Up to Week 24

• Change From Baseline in MADRS Total Score in Participants With Significant Insomnia (Baseline Insomnia Severity Index [ISI] Score >=15) Versus Those Without Significant Insomnia (Baseline ISI Score Less Than [<] 15) at Week 12

  Baseline and Week 12

• Change From Baseline in MADRS Total Score in Participants With Significant Insomnia (Baseline ISI Score >=15) Versus Those Without Significant Insomnia (Baseline ISI Score <15) at Week 18

  Baseline and Week 18

• Change From Baseline in MADRS Total Score in Participants With Significant Insomnia (Baseline ISIscore >=15) Versus Those Without Significant Insomnia (Baseline ISI Score 15) at Week 24

  Baseline and Week 24

Study Arms (2)

JNJ-42847922

EXPERIMENTAL

Participants will receive 20 mg of JNJ-42847922 as a starting dose and matching placebo (1 capsule of 20 mg JNJ-42847922 and 1 capsule of matching placebo) once daily for 14 days. After Day 14, if needed, JNJ-42847922 dose can be increased to 40 mg (2\*20 mg capsules) and flexible dose of JNJ-42847922 (20 or 40 mg) will be taken once daily until Day 167. Dose of JNJ-42847922 (20 or 40 mg) will be adjusted by investigator based on the participant's clinical response and tolerability. Participants will continue to take their baseline selective serotonin reuptake inhibitor (SSRI)/serotonin-norepinephrine reuptake inhibitor (SNRI) antidepressant as a part of background therapy (at the same dose, without change, every day and at approximately the same time as prior to entering the study) throughout the screening, double-blind, and follow-up phases.

Drug: JNJ-42847922; Drug: Placebo Matching to JNJ-42847922; Drug: Selective Serotonin Reuptake Inhibitor (SSRI); Drug: Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)

Quetiapine Extended-Release (XR)

ACTIVE COMPARATOR

Participants will receive 1 capsule of quetiapine XR 50 mg along with 1 capsule of matching placebo once daily for 2 days, followed by 1 capsule of quetiapine XR 150 mg along with 1 capsule of matching placebo once daily from Day 3 to Day 14. After Day 14, if needed, quetiapine XR dose can be increased to 300 mg (2\*150 mg capsules) and flexible dose of quetiapine (150 or 300 mg) will be taken once daily until Day 167. Dose of quetiapine XR (150 or 300 mg) will be adjusted by investigator based on the participant's clinical response and tolerability. Participants will continue to take their baseline SSRI/SNRI antidepressant as a part of background therapy (at the same dose, without change, every day and at approximately the same time as prior to entering the study) throughout the screening, double-blind, and follow-up phases.

Drug: Quetiapine XR; Drug: Placebo Matching to Quetiapine XR; Drug: Selective Serotonin Reuptake Inhibitor (SSRI); Drug: Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)

Interventions

JNJ-42847922 DRUG

Participants will receive JNJ-42847922 capsule orally.

Also known as: MIN-202;, Seltorexant

JNJ-42847922

Placebo Matching to JNJ-42847922 DRUG

Participants will receive placebo capsule matching to JNJ-42847922 orally.

JNJ-42847922

Quetiapine XR DRUG

Participants will receive quetiapine XR capsule orally.

Quetiapine Extended-Release (XR)

Placebo Matching to Quetiapine XR DRUG

Participants will receive placebo capsule matching to quetiapine XR orally.

Quetiapine Extended-Release (XR)

Selective Serotonin Reuptake Inhibitor (SSRI) DRUG

Participants will receive SSRI antidepressant (such as, citalopram, escitalopram, fluvoxamine, fluoxetine, paroxetine, sertraline, vilazodone or vortioxetine) as a part of background therapy (at the same dose, without change, every day and at approximately the same time as prior to entering the study) throughout the screening, double-blind, and follow-up phases (approximately up to Week 26).

JNJ-42847922; Quetiapine Extended-Release (XR)

Serotonin-Norepinephrine Reuptake Inhibitor (SNRI) DRUG

Participants will receive SNRI antidepressant (such as duloxetine, milnacipran, levomilnacipran, venlafaxine, desvenlafaxine) as a part of background therapy (at the same dose, without change, every day and at approximately the same time as prior to entering the study) throughout the screening, double-blind, and follow-up phases (approximately up to Week 26).

JNJ-42847922; Quetiapine Extended-Release (XR)

Eligibility Criteria

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

You may qualify if:

• Male or female of non-childbearing potential (WONCBP) outpatients, 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). 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 assessed 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, as specified in the MGH-ATRQ, for any particular antidepressant. The inadequate response must include the participant's current antidepressant treatment
• Be receiving monotherapy treatment for depressive symptoms with 1 of the following selective serotonin reuptake inhibitor (SSRI)/serotonin-norepinephrine reuptake inhibitor (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 participant 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
• Have a Body Mass Index (BMI) between 18 and 35 kilogram per meter square (kg/m\^2) inclusive (BMI equal to \[=\] weight/height\^2)
• 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 there are abnormalities, they must be consistent with the underlying illness in the study population. If the results of the clinical laboratory tests are outside the normal reference ranges, the participant may 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:

• Have Cushing's Disease, Addison's Disease, primary amenorrhea, or other evidence of significant medical disorders of the hypothalamic-pituitary-adrenal (HPA) axis
• Have a history of epilepsy, neuroleptic malignant syndrome (NMS) or Tardive Dyskinesia
• Have a history of previous non-response to an adequate trial of quetiapine as an adjunctive treatment for MDD (adequate trial defined as \>=150 mg for 4 weeks or more) and/or a history of lack of response to 3 or more adequate antidepressant treatments and/or a history or evidence of noncompliance with current antidepressant therapy
• Have taken a known moderate or strong inhibitor/inducer of cytochrome P450 (CYP)3A4 and CYP2C9 or a dual inhibitor/inducer of CYP3A4 and CYP2C9 within 14 days (or after washout that is, duration of 5 times the drug's half-life) before the first study drug administration on Day 1 until the follow-up visit. Fluvoxamine is a moderate CYP2C9 inhibitor and a mild CYP3A inhibitor, and will not be excluded from the study
• Have a history or current diagnosis of a psychotic disorder, bipolar disorder, intellectual disability, autism spectrum disorder, borderline personality disorder, somatoform disorders, or fibromyalgia

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (50)

NoesisPharma Research

Phoenix, Arizona, 85032, United States

Location

Clinical Research Consortium Arizona

Tempe, Arizona, 85283, United States

Location

Woodland Research Northwest

Rogers, Arkansas, 72758, United States

Location

Collaborative NeuroScience Network

Garden Grove, California, 92845, United States

Location

Pacific Institute of Medical Sciences

Los Angeles, California, 90024, United States

Location

National Research Institute

Los Angeles, California, 90057, United States

Location

Excell Research Inc

Oceanside, California, 92056, United States

Location

Desert Valley Research

Rancho Mirage, California, 92270, United States

Location

Anderson Clinical Research

Redlands, California, 92374, United States

Location

Artemis Institute for Clinical Research

San Diego, California, 92103, United States

Location

Syrentis Clinical Research

Santa Ana, California, 92705, United States

Location

Research Center for Clinical Studies, Inc.

Norwalk, Connecticut, 06851, United States

Location

Clinical Research of South Florida

Coral Gables, Florida, 33134, United States

Location

SIH Research

Kissimmee, Florida, 34759, United States

Location

Premier Clinical Research

Miami, Florida, 33122, United States

Location

Innova Clinical Trials

Miami, Florida, 33133, United States

Location

Arocha Research Center Inc

Miami, Florida, 33145, United States

Location

Suncoast Clinical Research

New Port Richey, Florida, 34652, United States

Location

Stedman Clinical Trials

Tampa, Florida, 33613, United States

Location

Northwest Behavioral Research Center

Marietta, Georgia, 30060, United States

Location

Suburban Clinical Research Group, Inc

Bolingbrook, Illinois, 60490, United States

Location

RxClinicals

Crystal Lake, Illinois, 60012, United States

Location

Alexian Brothers Health System

Hoffman Estates, Illinois, 60169, United States

Location

Psychiatric Medicine Associates LLC

Skokie, Illinois, 60076, United States

Location

American Research, LLC

Jeffersonville, Indiana, 47130, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Phoenix Medical Research, Inc.

Prairie Village, Kansas, 66208, United States

Location

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21218, United States

Location

BTC of New Bedford

New Bedford, Massachusetts, 02740, United States

Location

Boston Clinical Trials & Medical Research

Roslindale, Massachusetts, 02135, United States

Location

Rochester Center for Behavioral Medicine (RCBM)

Rochester Hills, Michigan, 48307, United States

Location

Midwest Research Group

Saint Charles, Missouri, 63304, United States

Location

PsychCare Consultants Research

St Louis, Missouri, 63128, United States

Location

Clinical Research Consortium

Las Vegas, Nevada, 89119-5190, United States

Location

SPRI Clinical Trials, LLC

Brooklyn, New York, 11235, United States

Location

CNS Research Science, Inc.

Jamaica, New York, 11432, United States

Location

Hapworth Psychiatric Medical PLLC

New York, New York, 10019, United States

Location

Carolina Partners c/o Tripha Life Sciences

Raleigh, North Carolina, 27606, United States

Location

Patient Priority Clinical Sites LLC

Cincinnati, Ohio, 45215, United States

Location

Intend Research

Norman, Oklahoma, 73069, United States

Location

IPS Research Company

Oklahoma City, Oklahoma, 73103, United States

Location

Sooner Clinical Research

Oklahoma City, Oklahoma, 73112, United States

Location

BTC Network

Lincoln, Rhode Island, 02865, United States

Location

Hawkins Psychiatry, PC

Arlington, Texas, 76013, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Houston Endoscopy and Research Center, Inc.

Houston, Texas, 77079, United States

Location

Texas Center for Drug Development Inc

Houston, Texas, 77081, United States

Location

Pillar Clinical Research, LLC

Richardson, Texas, 75080, United States

Location

Ericksen Research and Development

Clinton, Utah, 84015, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98004, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

seltorexant; Selective Serotonin Reuptake Inhibitors

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs

Limitations and Caveats

As this was a flexibly dosed study, participants were not randomized into dose groups. History of intolerance or nonresponse to previous trials of quetiapine was an exclusion criterion, potentially biasing the sample. A discontinuation analysis by dose was confounded by the fact that participants were on the low dose for at least the first 14 days. As a result, a participant's dose could not reach a high mode dose until approximately 29 days from the start of treatment.

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: October 23, 2017
• First Posted: October 25, 2017
• Study Start: December 12, 2017
• Primary Completion: June 13, 2019
• Study Completion: June 27, 2019
• Last Updated: April 29, 2025
• Results First Posted: August 16, 2022

Record last verified: 2025-04

Locations

US (50)