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
NCT ID: NCT03321526
Last Updated: 2025-04-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
107 participants
INTERVENTIONAL
2017-12-12
2019-06-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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JNJ-42847922
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.
JNJ-42847922
Participants will receive JNJ-42847922 capsule orally.
Placebo Matching to JNJ-42847922
Participants will receive placebo capsule matching to JNJ-42847922 orally.
Selective Serotonin Reuptake Inhibitor (SSRI)
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).
Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)
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).
Quetiapine Extended-Release (XR)
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.
Quetiapine XR
Participants will receive quetiapine XR capsule orally.
Placebo Matching to Quetiapine XR
Participants will receive placebo capsule matching to quetiapine XR orally.
Selective Serotonin Reuptake Inhibitor (SSRI)
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).
Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)
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).
Interventions
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JNJ-42847922
Participants will receive JNJ-42847922 capsule orally.
Placebo Matching to JNJ-42847922
Participants will receive placebo capsule matching to JNJ-42847922 orally.
Quetiapine XR
Participants will receive quetiapine XR capsule orally.
Placebo Matching to Quetiapine XR
Participants will receive placebo capsule matching to quetiapine XR orally.
Selective Serotonin Reuptake Inhibitor (SSRI)
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).
Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)
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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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NoesisPharma Research
Phoenix, Arizona, United States
Clinical Research Consortium Arizona
Tempe, Arizona, United States
Woodland Research Northwest
Rogers, Arkansas, United States
Collaborative NeuroScience Network
Garden Grove, California, United States
Pacific Institute of Medical Sciences
Los Angeles, California, United States
National Research Institute
Los Angeles, California, United States
Excell Research Inc
Oceanside, California, United States
Desert Valley Research
Rancho Mirage, California, United States
Anderson Clinical Research
Redlands, California, United States
Artemis Institute for Clinical Research
San Diego, California, United States
Syrentis Clinical Research
Santa Ana, California, United States
Research Center for Clinical Studies, Inc.
Norwalk, Connecticut, United States
Clinical Research of South Florida
Coral Gables, Florida, United States
SIH Research
Kissimmee, Florida, United States
Premier Clinical Research
Miami, Florida, United States
Innova Clinical Trials
Miami, Florida, United States
Arocha Research Center Inc
Miami, Florida, United States
Suncoast Clinical Research
New Port Richey, Florida, United States
Stedman Clinical Trials
Tampa, Florida, United States
Northwest Behavioral Research Center
Marietta, Georgia, United States
Suburban Clinical Research Group, Inc
Bolingbrook, Illinois, United States
RxClinicals
Crystal Lake, Illinois, United States
Alexian Brothers Health System
Hoffman Estates, Illinois, United States
Psychiatric Medicine Associates LLC
Skokie, Illinois, United States
American Research, LLC
Jeffersonville, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
Phoenix Medical Research, Inc.
Prairie Village, Kansas, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
BTC of New Bedford
New Bedford, Massachusetts, United States
Boston Clinical Trials & Medical Research
Roslindale, Massachusetts, United States
Rochester Center for Behavioral Medicine (RCBM)
Rochester Hills, Michigan, United States
Midwest Research Group
Saint Charles, Missouri, United States
PsychCare Consultants Research
St Louis, Missouri, United States
Clinical Research Consortium
Las Vegas, Nevada, United States
SPRI Clinical Trials, LLC
Brooklyn, New York, United States
CNS Research Science, Inc.
Jamaica, New York, United States
Hapworth Psychiatric Medical PLLC
New York, New York, United States
Carolina Partners c/o Tripha Life Sciences
Raleigh, North Carolina, United States
Patient Priority Clinical Sites LLC
Cincinnati, Ohio, United States
Intend Research
Norman, Oklahoma, United States
IPS Research Company
Oklahoma City, Oklahoma, United States
Sooner Clinical Research
Oklahoma City, Oklahoma, United States
BTC Network
Lincoln, Rhode Island, United States
Hawkins Psychiatry, PC
Arlington, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Houston Endoscopy and Research Center, Inc.
Houston, Texas, United States
Texas Center for Drug Development Inc
Houston, Texas, United States
Pillar Clinical Research, LLC
Richardson, Texas, United States
Ericksen Research and Development
Clinton, Utah, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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42847922MDD2002
Identifier Type: OTHER
Identifier Source: secondary_id
CR108394
Identifier Type: -
Identifier Source: org_study_id
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