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A Study of JNJ-61393215 in the Treatment of Depression

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ClinicalTrials.gov Identifier: NCT04080752
Recruitment Status : Recruiting
First Posted : September 6, 2019
Last Update Posted : September 24, 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-61393215 as adjunctive treatment compared to adjunctive placebo, as assessed by the change from baseline to week 6 on a 17-item Hamilton Depression Rating Scale (HDRS-17) in participants with major depressive disorder (MDD) with anxious distress with a score greater than or equal to (>=) 2 on item 26 or 27 of the Inventory of Depressive Symptomatology, Clinician Rating -30 (IDS-C30), who have a suboptimal response to current treatment with a standard antidepressant.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder With Anxious Distress Drug: JNJ-61393215 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 218 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Double-Blind, Placebo-Controlled, Multi-Center Study Investigating the Efficacy, Safety, and Tolerability of JNJ-61393215 as Adjunctive Treatment in Adults With Major Depressive Disorder With Anxious Distress With Suboptimal Response to Standard Antidepressants
Actual Study Start Date : September 17, 2019
Estimated Primary Completion Date : May 24, 2021
Estimated Study Completion Date : July 23, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: JNJ-61393215 135 milligram (mg)
Participants will receive JNJ-61393215 135 mg (3*45 mg capsules) orally once daily for 6 weeks along with the prescribed standard oral antidepressants (without dose change) throughout the study.
Drug: JNJ-61393215
JNJ-61393215 will be administrated orally.
Other Name: Orexin-1

Placebo Comparator: Placebo
Participants will receive matching placebo for 6 weeks along with the prescribed standard oral antidepressants (without dose change) throughout the study.
Drug: Placebo
Matching placebo will be administered orally.




Primary Outcome Measures :
  1. Change From Baseline in Hamilton Depression Rating Scale-17 (HDRS-17) Total Score up to Week 6 [ Time Frame: Baseline up to Week 6 ]
    HDRS-17 is a Clinician-Administered rating scale designed to assess the severity of symptoms in participants diagnosed with depression with a total score range of 0 to 52 with higher scores indicting greater severity of depressive symptoms.


Secondary Outcome Measures :
  1. Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score up to Week 6 [ Time Frame: Baseline up to Week 6 ]
    HAM-A scale measures the severity of a participant's anxiety, based on 14 parameters, including anxious mood, tension, fears, insomnia, somatic complaints and behavior at the interview. Each of the 14 items is rated by the clinician on a 5-point scale ranging from 0 (not present) to 4 (severe). The total score ranges from 0 to 56, where higher score indicates worsening. In this study, the Structured Interview Guide version of the HAM-A (SIGH-A) will be used.

  2. Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score up to Weeks 2 and 4 [ Time Frame: Baseline up to Weeks 2 and 4 ]
    HAM-A scale measures the severity of a participant's anxiety, based on 14 parameters, including anxious mood, tension, fears, insomnia, somatic complaints and behavior at the interview. Each of the 14 items is rated by the clinician on a 5-point scale ranging from 0 (not present) to 4 (severe). The total score ranges from 0 to 56, where higher score indicates worsening. In this study, the SIGH-A will be used.

  3. Change from Baseline in HDRS-17 Total Score in Participants with a Baseline HAM-A Score Greater than or Equal to (>=) 20 up to Week 6 [ Time Frame: Baseline up to Week 6 ]
    HDRS-17 is a Clinician-Administered rating scale designed to assess the severity of symptoms in participants diagnosed with depression with a total score range of 0 to 52 with higher scores indicting greater severity of depressive symptoms.

  4. Change from Baseline in HAM-A Total Score in Participants with a Baseline HAM-A Score >=20 up to Week 6 [ Time Frame: Baseline up to Week 6 ]
    HAM-A scale measures the severity of a participant's anxiety, based on 14 parameters, including anxious mood, tension, fears, insomnia, somatic complaints and behavior at the interview. Each of the 14 items is rated by the clinician on a 5-point scale ranging from 0 (not present) to 4 (severe). The total score ranges from 0 to 56, where higher score indicates worsening. In this study, the SIGH-A will be used.

  5. Change from Baseline in Generalized Anxiety Disorder-7 (GAD-7) Total Score up to Week 6 [ Time Frame: Baseline up to Week 6 ]
    GAD-7 is a self-administrated test to assess generalized anxiety disorder. GAD-7 has 7 items, which measure severity of various signs of GAD according to reported response categories with each item is rated on a 4-point scale (0=not at all; 1=several days; 2=more than half the days; 3=nearly every day). Item responses are summed to yield a total score (range of 0 to 21), with higher scores indicating more anxiety.

  6. Change from Baseline in Patient Health Questionnaire (PHQ-9) Total Score up to Weeks 2, 4 and 6 [ Time Frame: Baseline up to Weeks 2, 4 and 6 ]
    PHQ-9 will be used as a participant-reported measure of depressive symptomatology. The PHQ-9 is a 9-item scale, where each item is rated on a 4-point scale (0=not at all, 1=several Days, 2=more than half the days, and 3=nearly every day), with a total score range of 0 to 27. The recall period is 2 weeks.

  7. Change from Baseline in HDRS-17 Total Score up to Weeks 2 and 4 [ Time Frame: Baseline up to Weeks 2 and 4 ]
    HDRS-17 is a Clinician-Administered rating scale designed to assess the severity of symptoms in participants diagnosed with depression with a total score range of 0 to 52 with higher scores indicting greater severity of depressive symptoms.

  8. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Up to Week 12 ]
    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.

  9. Area Under the Plasma Concentration-time Curve (AUC) of JNJ-61393215 [ Time Frame: Day 1 (Baseline), Days 15, 29 and 43 ]
    AUC is the area under the plasma concentration-time curve observed during a dosing interval.

  10. Trough Plasma Concentration (Ctrough) of JNJ-61393215 [ Time Frame: Day 1 (Baseline), Days 15, 29 and 43 ]
    Ctrough is defined as the observed plasma concentration before dosing or at the end of the dosing interval.

  11. Maximum Observed Plasma Concentration (Cmax) of JNJ-61393215 [ Time Frame: Day 1 (Baseline), Days 15, 29 and 43 ]
    Cmax is the maximum observed plasma concentration.

  12. Plasma Protein Binding (PPB) of JNJ-61393215 [ Time Frame: Week 6 (Day 43) ]
    Plasma protein binding (PPB) of JNJ-61393215 will be determined by using a liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS) method.



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.


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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:

  • Participants must have a body mass index (BMI) between 18 and 36 kilogram per meter square (kg/m^2)
  • Participants must have a primary diagnostic and statistical manual of mental disorders, 5th edition (DSM-5) diagnosis of major depressive disorder (MDD) with anxious distress, as assessed by the mini international neuropsychiatric inventory 7.0. Plus (MINI). Participants with a diagnosis of comorbid generalized anxiety disorder (GAD), post-traumatic stress disorder, persistent depressive disorder, attention deficit hyperactivity disorder (ADHD), social anxiety disorder or nicotine/caffeine dependence may be included, if MDD is primary diagnosis
  • Participants must have an inventory of depressive symptomatology, clinician rating-30 (IDS-C30) total score greater than or equal to (>=) 35 (moderate to severe depression)
  • Participant must not have received more than 3 failed antidepressant treatments (of adequate dose and duration), including their current treatment, in the current episode of depression, as documented by the massachusetts general hospital antidepressant treatment history questionnaire (MGH-ATRQ)
  • Participant must be currently receiving 1 of the following antidepressants for at least 6 weeks duration at screening, at an adequate therapeutic dose, as determined by the MGH-ATRQ and should remain on a stable dose throughout the study: bupropion, citalopram, escitalopram, sertraline, paroxetine, venlafaxine, desvenlafaxine, duloxetine, fluoxetine, vilazodone, vortioxetine, mirtazapine, agomelatine, nortriptyline, imipramine, amitriptyline and levomilnacipran
  • Participants must have a suboptimal response (improvement <50%) to the antidepressant used as their current treatment, as measured by the MGH-ATRQ
  • 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:

  • Participant has any other psychiatric condition including but not limited to: MDD with current psychotic features, bipolar disorder (including lifetime diagnosis), obsessive-compulsive disorder, borderline personality disorder, eating disorder (example: bulimia, anorexia nervosa), or schizophrenia (lifetime)
  • Age of onset of depression is after 55 years of age
  • Participant has a history of alcohol or substance use disorder (abuse/dependence) within 6 months prior to screening (nicotine and caffeine dependence are not exclusionary)
  • Participant has a current or recent (within the past year) history of clinically significant suicidal ideation (corresponding to a score of >= 3 for ideation) or any suicidal behavior within the past year, as validated on the Colombia suicide severity rating scale (C-SSRS) at screening or baseline
  • Length of current major depressive episode >60 months
  • Participant has organic brain disease or dementia or has known or suspected intellectual development disorder
  • Participant has been treated with at least one of the following treatments: (a) electroconvulsive therapy in the current episode; (b) deep brain stimulation (lifetime); (c) repetitive transcranial magnetic stimulation within 4 weeks prior to baseline visit
  • Participant has any clinically relevant medical condition that could potentially alter the absorption, metabolism, or excretion of the study intervention, such as liver disease or renal disease
  • Participant has a relevant history of any significant and/or unstable cardiovascular, respiratory, neurological (including seizures - uncomplicated childhood febrile seizures with no sequelae are not exclusionary) or significant cerebrovascular, renal, hepatic, dermatologic, hematologic, gastrointestinal or endocrine diseases
  • Participant has a clinically significant abnormal physical examination, vital signs or 12-lead electrocardiogram (ECG) at screening or baseline
  • Participant has a history of known demyelinating diseases such as multiple sclerosis or optic neuritis

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): NCT04080752


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: NCT04080752     History of Changes
Other Study ID Numbers: CR108655
2019-001683-29 ( EudraCT Number )
61393215MDD2001 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: September 6, 2019    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.

As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

URL: https://www.janssen.com/clinical-trials/transparency

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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
Antidepressive Agents
Psychotropic Drugs