Clinical trial NCT04080752: A Study of JNJ-61393215 in the Treatment of Depression
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder With Anxious Distress
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2019-09-06
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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. Hospitalization for cardiovascular event (myocardial infarction, unstable angina, stroke, transient ischemic attack) within 3 months prior to the first administration of study drug is exclusionary. Diabetes mellitus be allowed when the participant is stable (HbA1c less than 7.5% or 58 mmol/mol)
* Participant has a clinically significant abnormal physical examination, vital signs or 12-lead electrocardiogram (ECG) at screening or baseline Minor deviations in ECG, which are not considered to be of clinical significance to the investigator, are acceptable.If at screening visit QTcB or QTcF interval \>=450 ms for males or \>=470 ms for females, or \>480 ms if bundle branch block and prolongation of the QTc interval are present;participant is excluded
* Participant has a history of known demyelinating diseases such as multiple sclerosis or optic neuritis

Primary outcomes:
measure: Change From Baseline in Hamilton Depression Rating Scale-17 (HDRS-17) Total Score at Week 6
timeFrame: Baseline and Week 6
Secondary outcomes:
measure: Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at Week 6
timeFrame: Baseline and Week 6
measure: Change From Baseline in HAM-A Total Score at Weeks 2 and 4
timeFrame: Baseline, Week 2, and Week 4
measure: Change From Baseline in HDRS-17 Total Score in Participants With a Baseline HAM-A Score >=20 at Week 6
timeFrame: Baseline and Week 6
measure: Change From Baseline in HAM-A Total Score in Participants With a Baseline HAM-A Score >=20 at Week 6
timeFrame: Baseline and Week 6
measure: Change From Baseline in Generalized Anxiety Disorder-7 (GAD-7) Total Score at Week 6
timeFrame: Baseline and Week 6
measure: Change From Baseline in Patient Health Questionnaire (PHQ-9) Total Score at Weeks 2 and 4
timeFrame: Baseline, Week 2, and Week 4
measure: Change From Baseline in HDRS-17 Total Score at Weeks 2 and 4
timeFrame: Baseline, Week 2, and Week 4
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability
timeFrame: Up to 8 weeks
measure: Total Plasma Concentration of JNJ-61393215
timeFrame: 1-4 hours postdose on Day 1; Predose and 1-4 hours post dose on Days 15, 29, and 43
measure: Plasma Protein Binding (PPB): Percentage of JNJ-61393215 Unbound
timeFrame: Predose and 1-4 hours post dose on Day 43
Other outcomes:
Locations:
city: Garden Grove
country: United States
facility: Collaborative NeuroScience Network
state: California
city: Alpharetta
country: United States
facility: Atlanta Institute
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: New York
country: United States
facility: The Medical Research Network, LLC
state: New York
city: Staten Island
country: United States
facility: Richmond Behavioural Associates
state: New York
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research Company
state: Oklahoma
city: Media
country: United States
facility: Suburban Research Associates
state: Pennsylvania
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Chisinau
country: Moldova, Republic of
facility: ARENSIA
city: Moscow
country: Russian Federation
facility: City Clinical Psychiatric Hopsital 3
city: Nizny Novgorod
country: Russian Federation
facility: Nizny Novgorod clinical psychiatric hospital 1
city: Orenburg
country: Russian Federation
facility: Orenburg Regional Clinical Psychiatric Hospital #1
city: Rostov-on-Don
country: Russian Federation
facility: Medical and Rehabilitation Research Center Phoenix
city: Saratov Region
country: Russian Federation
facility: Engels psychiatric hospital
city: Saratov
country: Russian Federation
facility: SHI 'Saratov City Clinical Hospital 2 n.a V.I. Razumovsky
city: Saratov
country: Russian Federation
facility: Saratov Regional Psychiatric hospital named after St. Sofia
city: St-Petersburg
country: Russian Federation
facility: Psychoneurological dispensary 10
city: St-Petersburg
country: Russian Federation
facility: City Psychiatric hospital 7 named after I.P.Pavlov
city: St-Petersburg
country: Russian Federation
facility: Psychoneurological dispensary 1
city: St.Peterburg
country: Russian Federation
facility: Psychoneurological Dispensary #4
city: Stavropol
country: Russian Federation
facility: Stavropol Region Psychiatric Hospital #2
city: Tomsk
country: Russian Federation
facility: Research Institute of Mental Health
city: Glevakha
country: Ukraine
facility: MNCE of Kyiv RC Regional Psychiatric and Narcological Medical Association
city: Ivano-Frankivsk
country: Ukraine
facility: CNCE'Precarpathian Regional Clinical Mental Health Center Ivano-Frankivsk RC'
city: Kharkiv
country: Ukraine
facility: Mnpe of Kharkiv Regional Council 'Regional Clinical Psychiatric Hospital #3'
city: Kherson
country: Ukraine
facility: CNPE'Kherson Regional Institution of Mental Care'of Kherson Regional Council
city: Kyiv
country: Ukraine
facility: Kyiv Railway Station Clinical Hospital #2
city: Nove
country: Ukraine
facility: Mnpe 'Regional Clinical Psychiatric Hospital of Kirovohrad Regional Council'
city: Smila
country: Ukraine
facility: CNCE 'Cherkasy Regional Psychiatric Hospital of Cherkasy Regional Council'
city: Vinnytsia
country: Ukraine
facility: CNCE 'Vinnytsya RC Psychoneurological Hospital n.a. O.I. Yushchenko Vinnytsya RC'
city: Barnsley
country: United Kingdom
facility: MAC Clinical Research
city: Liverpool
country: United Kingdom
facility: MAC Clinical Research
city: London
country: United Kingdom
facility: Kings College London
city: Manchester
country: United Kingdom
facility: MAC Clinical Research
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: