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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

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ClinicalTrials.gov Identifier: NCT03321526
Recruitment Status : Recruiting
First Posted : October 25, 2017
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

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).

Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Drug: JNJ-42847922 Drug: Placebo Matching to JNJ-42847922 Drug: Quetiapine XR Drug: Placebo Matching to Quetiapine XR Drug: Selective Serotonin Reuptake Inhibitor (SSRI) Drug: Serotonin-Norepinephrine Reuptake Inhibitor (SNRI) Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A 6-Month, Multicenter, Double-Blind, Randomized, Flexible-Dose, Parallel-Group Study to Compare the Efficacy, Safety, and Tolerability of JNJ-42847922 Versus Quetiapine Extended-Release as Adjunctive Therapy to Antidepressants in Adult Subjects With Major Depressive Disorder Who Have Responded Inadequately to Antidepressant Therapy
Actual Study Start Date : December 12, 2017
Estimated Primary Completion Date : December 10, 2018
Estimated Study Completion Date : January 9, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants

Arm Intervention/treatment
Experimental: 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.
Drug: JNJ-42847922
Participants will receive JNJ-42847922 capsule orally.
Other Names:
  • MIN-202;
  • Seltorexant

Drug: Placebo Matching to JNJ-42847922
Participants will receive placebo capsule matching to JNJ-42847922 orally.

Drug: Selective Serotonin Reuptake Inhibitor (SSRI)
Participants will receive SSRI 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 (approximately up to Week 26).

Drug: Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)
Participants will receive 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 (approximately up to Week 26).

Active Comparator: 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.
Drug: Quetiapine XR
Participants will receive quetiapine XR capsule orally.

Drug: Placebo Matching to Quetiapine XR
Participants will receive placebo capsule matching to quetiapine XR orally.

Drug: Selective Serotonin Reuptake Inhibitor (SSRI)
Participants will receive SSRI 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 (approximately up to Week 26).

Drug: Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)
Participants will receive 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 (approximately up to Week 26).




Primary Outcome Measures :
  1. Time to All-Cause Discontinuation of Study Drug [ Time Frame: Up to 168 days ]
    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 for participants who discontinued study drug.


Secondary Outcome Measures :
  1. Percentage of Participants Achieving Remission at Week 12 and Sustaining Remission at Weeks 18 and 24 [ Time Frame: Weeks 12, 18 and 24 ]
    Percentage of participants achieving remission at Week 12 and sustaining remission at Weeks 18 and 24 will be reported. Remission is defined as Montgomery-Asberg Depression Rating Scale (MADRS) total score less than or equal to (<=)12. MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 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 of 60. Higher scores represent a more severe condition.

  2. Percentage of Participants Achieving Response at Week 12 and Sustaining Response at Weeks 18 and 24 [ Time Frame: Weeks 12, 18 and 24 ]
    Percentage of participants achieving response at Week 12 and sustaining response at Weeks 18 and 24 will be reported. Response is defined as greater than or equal to (>=)50 percent (%) improvement from baseline MADRS total score. MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 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 of 60. Higher scores represent a more severe condition.

  3. 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 <15) at Weeks 12, 18, and 24 [ Time Frame: Baseline, Weeks 12, 18, and 24 ]
    MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 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 of 60. Higher scores represent a more severe condition. The ISI is a commonly used, 7-item psychometrically validated measure used to rate insomnia with a score: 0-7=no clinically significant insomnia; score 8-14=sub-threshold insomnia; score 15-21=moderate insomnia, and score 22-28=clinically severe insomnia.

  4. Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A) Total Score at Weeks 12, 18, and 24 [ Time Frame: Baseline, Weeks 12, 18, and 24 ]
    HAM-A is a 14-item scale based on structured interview guide designed to measure anxiety in individuals. Each question reflects a symptom of anxiety and physical as well as mental symptoms are represented. The answers range from 0 (a complete lack of that symptom) to 4 (a very severe show of anxiety with that symptom). The total score is sum of 14 items and ranges from 0 to 56, where higher score indicates worsening.

  5. Percentage of Participants With Weight Gain >=7% of Baseline Body Weight at End-of-Study Assessment [ Time Frame: Baseline and end-of-study (at Week 26) ]
    Percentage of participants with weight gain >=7% of baseline body Weight will be analyzed at end-of-study.

  6. Percentage of Participants With Shifts in Triglycerides From Normal to High [ Time Frame: Baseline, Weeks 6, 12, and 24 ]
    Percentage of participants with shifts in triglycerides from normal to high (less than [<]150 milligram per deciliter [mg/dL] at baseline to >=200 mg/dL at Weeks 6, 12, and 24) will be assessed.

  7. Percentage of Participants With Shifts in Triglycerides From Borderline to High [ Time Frame: Baseline, Weeks 6, 12, and 24 ]
    Percentage of participants with shifts in triglycerides from borderline to high (>=150 and <200 mg/dL at baseline to >=200 mg/dL at Weeks 6, 12, and 24) will be assessed.

  8. Percentage of Participants With Shifts in Triglycerides From Normal to Very High [ Time Frame: Baseline, Weeks 6, 12, and 24 ]
    Percentage of participants with shifts in triglycerides from normal to very high (<150 mg/dL at baseline to >=500 mg/dL at Weeks 6, 12, and 24) will be assessed.

  9. Percentage of Participants With Shifts in Triglycerides From Borderline to Very High [ Time Frame: Baseline, Weeks 6, 12, and 24 ]
    Percentage of participants with shifts in triglycerides from borderline to very high (>=150 mg/dL and <200 mg/dL at baseline to >=500 mg/dL at Weeks 6, 12, and 24) will be assessed.

  10. Percentage of Participants With Shifts in Triglycerides From High to Very High [ Time Frame: Baseline, Weeks 6, 12, and 24 ]
    Percentage of participants with shifts in triglycerides from high to very high (>=200 mg/dL and <500 mg/dL at baseline to >=500 mg/dL at Weeks 6, 12, and 24) will be assessed.

  11. Percentage of Participants With Shifts in Fasting Blood Glucose From Normal to Borderline [ Time Frame: Baseline, Weeks 6, 12, and 24 ]
    Percentage of participants with shifts in fasting blood glucose from normal to borderline (<100 mg/dL at baseline to >=100 and <126 mg/dL at Weeks 6, 12, and 24) will be assessed.

  12. Percentage of Participants With Shifts in Fasting Blood Glucose From Borderline to High [ Time Frame: Baseline, Weeks 6, 12, and 24 ]
    Percentage of participants with shifts in fasting blood glucose from borderline to high (>=100 to <126 mg/dL at baseline to >=126 mg/dL at Weeks 6, 12, and 24) will be assessed.

  13. Percentage of Participants With Shifts in Fasting Blood Glucose From Normal to High [ Time Frame: Baseline, Weeks 6, 12, and 24 ]
    Percentage of participants with shifts in fasting blood glucose from normal to high (<100 mg/dL at baseline to >=126 mg/dL at Weeks 6, 12, and 24) will be assessed.

  14. Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Score at Weeks 12 and 24 [ Time Frame: Baseline, Weeks 12 and 24 ]
    The Clinical Global Impression Severity (CGI-S) rating scale measures the clinician's impression of the severity of illness exhibited by a participant that takes into account all available information, including knowledge of the participant's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the participant's ability to function. The CGI-S evaluates the severity of psychopathology on a scale of 1 to 7. Considering total clinical experience with the depression population, a participant is assessed on severity of illness at the time of rating according to: 1=normal (not at all ill); 2=borderline ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill participants. Higher scores indicate worsening.

  15. Change From Baseline in the Patient Global Impression Severity (PGI-S) Score at Weeks 12 and 24 [ Time Frame: Baseline, Weeks 12 and 24 ]
    The PGI-S is a self-report 4-point scale to measure severity of illness (1=none, 2=mild, 3=moderate, 4=severe). Considering all aspects of depression, participants will rate their severity on the PGI-S.

  16. Change From Baseline in Quality of Life in Depression Scale (QLDS) at Weeks 12 and 24 [ Time Frame: Baseline, Weeks 12 and 24 ]
    The QLDS is a disease specific scale designed to assess health related quality of life in participants with major depressive disorder (MDD). The instrument has a recall period of "at the moment", contains 34-items with "yes"/"no" response options and takes approximately 5 to 10 minutes to complete. The score range is from 0 (good quality of life) to 34 (very poor quality of life).

  17. Change From Baseline in Patient Reported Outcomes Measurement Information System-Sleep Disturbance (PROMIS-SD Short Form 8a) at Weeks 12 and 24 [ Time Frame: Baseline, Weeks 12 and 24 ]
    The PROMIS-Sleep Disturbance (PROMIS-SD) is used to asses self-reported perceptions of sleep quality, sleep depth and restoration associated with sleep. The full PROMIS-SD includes 27 items with each item based on a 7-day recall period and assessed on a 5 level Likert-type scale. The 8-item short form will be used in this study, in which responses are scored 1 to 5 for each item. A higher score on 5 of the 8 items reflects a worse outcome, whereas a higher score on 3 items reflects an improved outcome; therefore, the directionality of the 8 item scores are first synchronized prior to calculation of the total raw score. To find the total raw score for a short form with all questions answered, sum the values of the response to each question. For example, for the adult 8-item form, the lowest possible raw score is 8; the highest possible raw score is 40. Higher overall score indicates more sleep disturbance.

  18. Change From Baseline in Patient Reported Outcomes Measurement Information System-Sleep Related Impairment (PROMIS-SRI Short Form 8a) at Weeks 12 and 24 [ Time Frame: Baseline, Weeks 12 and 24 ]
    The Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Related Impairment bank is a 16 item computer adaptive test bank that focuses on perceptions of alertness, sleepiness, and tiredness during usual waking hours and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. The PROMIS-SRI Short Form subscale consists of a static 8 item questionnaire. Each item is based on a seven day recall period and assessed on a 5 score for with all questions answered, sum the values of the response to each question. For example, for the 8-item form, the lowest possible raw score is 8 and the highest possible raw score is 40. Higher score indicates more sleep impairment.

  19. Change From Baseline in Symptoms of Major Depressive Disorder Scale (SMDDS) at Weeks 12 and 24 [ Time Frame: Baseline, Weeks 12 and 24 ]
    The SMDDS assesses participant-reported symptoms associated with MDD. This 16-item instrument has a 7-day recall period, and participants respond to each question using a rating scale between 0 ("Not at all" or "Never") to 4 ("Extremely" or "Always"). The total score ranges from 0 to 60 with a higher score indicating more severe depressive symptomatology.

  20. Change From Baseline in Symbol Digit Modalities Test (SDMT) at Weeks 6, 12, and 24 [ Time Frame: Baseline, Weeks 6, 12, and 24 ]
    The SDMT is a widely used, paper-and-pencil assessment of complex scanning and visual tracking, requiring elements of attention, visuoperceptual processing, working memory, and cognitive/psychomotor speed. The test is viewed as a robust screening test for adult neuropsychological impairment and has been used to demonstrate worse cognitive functioning in participants with MDD. The test includes a coding key consisting of 9 abstract symbols, each paired with a number ranging from 1 to 9. Following the key, the participant is presented with randomly ordered symbols and is required to write the number corresponding to each symbol as fast as possible. The number of correct substitutions within 90 seconds is recorded by examiner-administered cognitive test battery. The score is the number of correctly coded items from 0-110 in 90 seconds.

  21. Change From Baseline in Trail Making Test - Part B (TMT-Part B) at Weeks 6, 12, and 24 [ Time Frame: Baseline, Weeks 6, 12, and 24 ]
    The TMT-B measures divided attention and executive function (tracking and sequencing). The participant is instructed to draw a line to connect a set of 25 consecutively numbered and lettered circles, alternating sequentially between numbers and letters (that is, 1-A-2-B). The participant is instructed to work as quickly as possible while still maintaining accuracy. The TMT-B has acceptable reliability; reliability coefficients have typically been reported as exceeding 0.65. The TMT-B is sensitive to cognitive decline associated with MDD.

  22. Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) at Weeks 6, 12, and 24 [ Time Frame: Baseline, Weeks 6, 12, and 24 ]
    The HVLT-R, a measure of verbal learning and memory, is a 12-item word list recall test. Administration includes 3 learning trials, a delayed recall (20-minute) trial, and a 24-word recognition list (including 12 target and 12 foil words). The test administrator reads instructions and word lists aloud, and records words recalled/recognized by the participant. Three learning trials are combined to calculate a total recall score learning, delayed recall, and recognition trials.

  23. Change From Baseline in Salivary Cortisol Levels as Measured at Home Upon Awakening and at Home During the Evening at Weeks 6 and 24 [ Time Frame: Baseline, Weeks 6 and 24 ]
    Change from baseline in salivary cortisol levels will be measured.

  24. Number of Participants With Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Up to 26 weeks ]
    An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

  25. Percentage of Participants With all Serious Adverse Events (SAEs) and Events of Special Interest [ Time Frame: Up to 26 weeks ]
    An SAE is any adverse event (AE) that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. All SAEs and events of special interest including cataplexy (sudden, transient episode of muscle weakness accompanied by conscious awareness), sleep paralysis (the experience of not being able to move, react, or speak when falling asleep/awakening), and complex, sleep-related behaviors/parasomnias such as confusional arousals, somnambulism (sleep walking), sleep terrors, bruxism (teeth grinding), sleep sex, sleep related eating disorder, sleep behavior disorder, and catathrenia (Rapid Eye Movement [REM]-associated end-inspiratory apnea/breath holding) will be reported.

  26. Number of Participants With Clinically Significant Vital Sign Findings as a Measure of Safety and Tolerability [ Time Frame: Up to 26 weeks ]
    Vital signs includes temperature, pulse/heart rate, respiratory rate and blood pressure.

  27. Number of Participants With Clinically Significant Physical Examination Findings as a Measure of Safety and Tolerability [ Time Frame: Up to 26 weeks ]
    Physical examination includes examination of height, body weight, and waist circumference.

  28. Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings as a Measure of Safety and Tolerability [ Time Frame: Up to 26 weeks ]
    A 12-lead ECG will be performed.

  29. Number of Participants With Clinically Significant Laboratory Findings as a Measure of Safety and Tolerability [ Time Frame: Up to 26 weeks ]
    Blood samples for serum chemistry, hematology, and urinalysis will be collected at predefined time points for clinical laboratory testing.

  30. Participant's Sexual Functioning Measured by the Arizona Sexual Experiences Scale (ASEX) [ Time Frame: Weeks 1, 12, and 24 ]
    The ASEX is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Possible total scores range from 5 to 30, with the higher scores indicating more sexual dysfunction.

  31. Participant's Extrapyramidal Symptoms Assessed by the Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) [ Time Frame: Weeks 2, 4, 6, 12, and 24 ]
    The ESRS-A is an abbreviated manualized version of the ESRS, a semi-structured interview that rates parkinsonian symptoms, dystonia, dyskinesias, and akathisia over the previous 7 days. The ratings include a motor examination for rigidity, tremor, reduced facial expression or speech, impaired gait/posture, postural instability, and bradykinesia/hypokinesia. Twenty-four individual items are rated on 6-point scale: 0=Absent, 1=Minimal, 2=Mild, 3=Moderate, 4=Severe, or 5=Extreme.

  32. Participant's Suicidality Ideation Assessed Using Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Up to 26 weeks ]
    C-SSRS is a clinician rated assessment of suicidal behavior and/or intent. Scale consists of 28 items in 4 sections: suicide behavior, actual attempts, suicidal ideation, and intensity of ideation. In this study, emergence of suicidal ideation will be assessed using the C-SSRS. Suicidal ideation consists of 5 'yes/no' items: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intention to act, active suicidal ideation with some intent to act without specific plan, active suicidal ideation with specific plan and intent. Only items with yes responses are listed. Worsening of suicidal ideation is an increase in severity of suicidal ideation from baseline.

  33. Participant's Potential Withdrawal Effects Assessed by the Physician Withdrawal Checklist (PWC) [ Time Frame: Week 26 ]
    Participant's potential withdrawal effects will be assessed by the 20-item PWC. The PWC is a simple and accurate method used to assess potential withdrawal symptoms following cessation of treatment. The PWC-20 is a reliable and sensitive instrument for the assessment of potential withdrawal symptoms following cessation of treatment. Each individual item score ranges from 0 (not present) to 3 (severe), where higher scores = more affected condition.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03321526


Contacts
Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

  Show 58 Study Locations
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

Additional Information:
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT03321526     History of Changes
Other Study ID Numbers: CR108394
42847922MDD2002 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: October 25, 2017    Key Record Dates
Last Update Posted: November 19, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Quetiapine Fumarate
Norepinephrine
Serotonin
Serotonin Uptake Inhibitors
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Uptake Inhibitors