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A Study to Explore the Efficacy of JNJ-67953964 in the Treatment of Depression

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ClinicalTrials.gov Identifier: NCT03559192
Recruitment Status : Recruiting
First Posted : June 18, 2018
Last Update Posted : July 1, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief Summary:
The purpose of this study is to evaluate the efficacy of JNJ-67953964 compared to placebo when administered as adjunctive treatment in participants with Major Depressive Disorder (MDD) partially responsive to selective serotonin reuptake inhibitor/ serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) treatment in terms of reduction of symptoms of depression, as assessed by the change from baseline on the Montgomery Asberg Depression Rating Scale (MADRS) in non-responders during the placebo lead-in period.

Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Drug: JNJ-67953964 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2a Randomized, Double-blind, Placebo-Controlled, Parallel-Group, Multi-center Study Investigating the Efficacy, Safety, Tolerability and Pharmacokinetics of JNJ-67953964 in Subjects With Major Depressive Disorder
Actual Study Start Date : July 16, 2018
Estimated Primary Completion Date : November 11, 2019
Estimated Study Completion Date : May 13, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Lead-in Period: Placebo
Participants will receive matching placebo for the entire duration of the lead-in period.
Drug: Placebo
Matching placebo will be administered as 2 capsules orally once daily.

Experimental: Treatment Period: JNJ-67953964 or Placebo
Participants who respond or do not respond (based on reduction from lead-in baseline in MADRS) in the placebo lead-in period will receive either matching placebo or 10 (2*5) milligram (mg) JNJ-67953964 capsules in a 1:1 ratio for 6 weeks.
Drug: JNJ-67953964
JNJ-67953964 10 mg will be administered as two 5-mg capsules orally once daily.

Drug: Placebo
Matching placebo will be administered as 2 capsules orally once daily.

Placebo Comparator: Withdrawal Period: Placebo
Participants who complete the double-blind treatment period prior to the end of Week 11 will receive matching placebo for the remaining time of the treatment phase of the study.
Drug: Placebo
Matching placebo will be administered as 2 capsules orally once daily.




Primary Outcome Measures :
  1. Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Score up to Treatment Week 6 [ Time Frame: Treatment Baseline up to Treatment Week 6 ]
    The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which 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.


Secondary Outcome Measures :
  1. Change From Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Score up to Treatment Week 6 [ Time Frame: Treatment Baseline up to Treatment Week 6 ]
    The SHAPS is a self-report 14-item, instrument, developed for the assessment of hedonic capacity. Participants score whether they experience pleasure in performing a list of activities or experiences. Participants can rate the answers as "definitely/strongly agree", "agree", "disagree" or "strongly disagree". "Definitely agree" will be rated 1, "Agree" will be rated 2, "Disagree" will be rated 3, and "Definitely disagree" will be rated 4. The participant's item responses are summed to provide a total score ranging from 14 to 56. A higher total SHAPS score indicates higher levels of current anhedonia.

  2. Change From Baseline in Clinical Global Impression - Severity (CGI-S) Scores up to Treatment Week 6 [ Time Frame: Treatment Baseline up to Treatment Week 6 ]
    The CGI-S evaluates the severity of psychopathology on a scale of 0 to 7. Considering total clinical experience, a participant is assessed on severity of mental illness at the time of rating according to: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. The CGI-S permits a global evaluation of the participant's condition at a given time.

  3. Change From Baseline in Symptoms of Major Depressive Disorder Scale (SMDDS) Total Scores up to Treatment Week 6 [ Time Frame: Treatment Baseline up to Treatment Week 6 ]
    The SMDDS is a 16-item patient reported outcome (PRO) measure. Each item will be rated by the participant according to a 5-point Likert scale. 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. The SMDDS uses a 7-day recall period and verbal rating scales.

  4. Change From Baseline in Self-Assessment of Treatment Experience (SATE) Score up to Treatment Week 6 [ Time Frame: Treatment Baseline up to Treatment Week 6 ]
    The SATE questionnaire is a 1- or 2-item self-report scale designed to provide additional information regarding the participant's subjective experience on depression since starting the study medication. This is a qualitative scale and the responses will be recorded as 'very much improved', 'much improved', 'improved', 'no change', 'worse', 'much worse', and 'very much worse'.

  5. Change From Baseline in Hamilton Anxiety Scale 6 (HAM-A6) Score up to Treatment Week 6 [ Time Frame: Treatment Baseline up to Treatment Week 6 ]
    The HAM-A scale assesses the severity of different anxiety-related symptoms with a score range of 0 to 52. Each of the 14 items is rated by the clinician on a 5-point scale ranging from 0 (not present) to 4 (maximum degree). The 6 item subscale from HAM-A (HAM-A6) is a uni-dimensional, 6-item subscale derived from the original HAM-A. The HAM-A6 comprises of five psychic anxiety symptoms: anxious mood, psychic tension, fears, intellectual disturbances, and anxious behaviour observed at the interview, as well as one somatic item, muscular tension, with a score range of 0 to 24. Higher scores represent more severe anxiety symptoms.

  6. Change From Baseline in Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) Score up to Treatment Week 6 [ Time Frame: Treatment Baseline up to Treatment Week 6 ]
    SIGH-A is a 14-item scale to measure severity of different anxiety-related symptoms in participants. Each of the 14 items is rated by the clinician on a 5-point scale ranging from 0 (not present) to 4 (maximum degree) with a total score range of 0 to 52 where higher score indicates worsening.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a Body Mass Index (BMI) between 18 and 35 kilogram per meter square (kg/m^2) inclusive (BMI = weight/height^2)
  • Participants must be medically stable based on clinical laboratory tests, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and baseline
  • Participants must have a primary Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) diagnosis of Major Depressive Disorder (MDD)

    1. The current episode should be less than 18 months
    2. Participants should be currently treated with an SSRI or SNRI at an adequate dose and for at least 6 weeks but no more than 12 months
    3. Have a Montgomery-Asberg Depression Rating Scale (MADRS) total score greater than or equal to (>=) 25 at screening
  • A woman of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test before the first dose

Exclusion Criteria:

  • History of documented gastric disease (including documented peptic ulcer disease, gastritis, upper gastrointestinal [GI] bleeding, esophagitis, or any GI precancerous condition), current clinically evident GI complaints
  • Chronic use of a proton pump inhibitors (PPIs). History of incidental use of PPIs is allowed but should have been stopped at least 4 weeks before screening. A history of chronic nonsteroidal anti-inflammatory drug (NSAID) or aspirin use. (Low dose aspirin for example in cardiovascular disease prevention is allowed)
  • Has a history of alcohol use disorder within the past year
  • Has failed (no more than 25 percent [%] response on Antidepressant Treatment History Questionnaire [ATRQ]) three or more antidepressant treatments including the current Selective serotonin reuptake inhibitor/ serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) during the current depressive episode despite an adequate dose (per ATRQ) and duration (at least 6 weeks)
  • Has signs or symptoms of Cushing's Disease, Addison's Disease, primary amenorrhea, or other evidence of significant medical disorders of the hypothalamus pituitary adrenal (HPA) axis
  • Participant has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 3 months before the planned first dose of study drug or has participated in any interventional clinical studies on MDD in the previous 1 year or is currently enrolled in an interventional study
  • Has one or more of the following diagnoses:

    1. A primary DSM (5th edition) diagnosis of generalized anxiety disorder (GAD), panic disorder, obsessive compulsive disorder (OCD), posttraumatic stress disorder (PTSD). Participants with comorbid GAD, social anxiety disorder (SAD), or panic disorder for whom MDD is considered the primary diagnosis are not excluded
    2. A current diagnosis or diagnosis in the past 1 year of psychotic disorder, MDD with psychosis, anorexia nervosa or bulimia nervosa, chronic fatigue syndrome, bipolar disorder (BD), mental retardation, antisocial or borderline personality disorder, autism spectrum disorder
  • Has a current or recent history of clinically significant suicidal ideation within the past 6 months, corresponding to a score of 4 (active suicidal ideation with some intent to act, without specific plan) or 5 (active suicidal ideation with specific plan and intent) for ideation on the Colombia suicide severity rating scale (C-SSRS), or a history of suicidal behavior within the past 1 year
  • Ongoing psychological treatments (example, Cognitive Behavior Therapy, Interpersonal Psychotherapy, Psychodynamic Psychotherapy, etcetera [etc.]), initiated within 1 month prior to the screening phase. A participant who has been receiving ongoing psychological treatment for a period of greater than 1 month from the screening visit is eligible, if the investigator deems the psychological treatment to be of stable duration and frequency
  • Participant has a history of substance use disorder according to DSM-5 criteria, except nicotine or caffeine, within 6 months before screening. Mild cases can be reviewed on a case by case basis. Participants who have completed a treatment for (alcohol) addiction more than 1 year prior to first dose administration, may be included if the risk of relapse is considered minimal, total duration of alcohol use disorder was less than a year, and no significant abnormalities are shown in clinical laboratory or other pre-dose safety assessments
  • Participant has used:

    1. Monoamine oxidase inhibitors (MAOIs) within 12 weeks before screening
    2. St. John's wort, ephedra, ginkgo, ginseng, or kava within 2 weeks before screening
    3. Antipsychotic drugs (D2-antagonists) within 2 weeks before screening. However, Seroquel (quetiapine) in a dose less than or equals to (<=)100 milligram (mg) is allowed when used in a stable dose for at least 8 weeks prior to screening. Quetiapine treatment should be continued unchanged during the study
    4. Opioids within 2 weeks before screening
    5. Psychostimulants such as methylphenidate or dextroamphetamine within 2 weeks before screening
    6. Psychotropics with antidepressant effects such as atomoxetine or thyroid supplementation, in addition to their SSRI or SNRI treatment within 2 weeks before screening
  • Participant is unable to stop the following medication from the baseline visit (Visit 2) and throughout the study (tapering during screening period allowed): Any hypnotics including but not limited to: i. Benzodiazepines when used only as needed (PRN) are not allowed ii. Sedating antihistamines, including chronic use of diphenhydramine iii. Continuous use of zolpidem, zoplicon, eszopiclone and ramelteon. Note: Nonbenzodiazepines sleep aids (including: zolpidem, zaleplon, and eszopliclone) are allowed on an as needed (PRN) basis during the study but NOT within 24 hours before being in the clinic and not more than 2 nights in a row iv. S-adenosyl methionine (SAMe) v. Melatonin, agomelatine
  • Has received any prior treatment with electroconvulsive therapy, vagal nerve stimulation, or a deep brain stimulation device or treatment with ketamine or esketamine for MDD

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): NCT03559192


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

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

Additional Information:
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT03559192     History of Changes
Other Study ID Numbers: CR108487
67953964MDD2001 ( Other Identifier: Janssen Research & Development, LLC )
2019-000695-41 ( EudraCT Number )
First Posted: June 18, 2018    Key Record Dates
Last Update Posted: July 1, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms