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

INTERVENTION: Product Name: JNJ‐61393215, 45‐mg Pharmaceutical Form: Capsule, hard INN or Proposed INN: N/A CAS Number: 1637681‐55‐0 Other descriptive name: JNJ‐61393215‐AAA Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 45‐ Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use CONDITION: Adjunctive Treatment in Adults with Major Depressive Disorder with Anxious Distress with Suboptimal Response to Standard Antidepressants ; MedDRA version: 21.1 Level: LLT Classification code 10025453 Term: Major depressive disorder NOS System Organ Class: 100000004873 Therapeutic area: Psychiatry and Psychology [F] ‐ Mental Disorders [F03] PRIMARY OUTCOME: Main Objective: The primary objective 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 (HDRS17) in participants with MDD with anxious distress with a score = 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. Primary end point(s): The change from baseline to week 6 on a 17‐item Hamilton Depression Rating Scale (HDRS17) Secondary Objective: The key secondary objective is to evaluate the impact of adjunctive treatment with JNJ‐61393215 compared to adjunctive placebo on the severity of anxiety as measured by the change in the Hamilton Anxiety Rating scale (HAM‐A) from baseline to Week 6.; ; Timepoint(s) of evaluation of this end point: HDRS17 at baseline and week 6. SECONDARY OUTCOME: Secondary end point(s): 1. change in Hamilton anxiety scale (HAM‐A) from baseline to weeks 2 and 4. ; 2. the change from baseline to Week 6 on the HDRS17 in participants with a baseline HAM‐A score =20. ; 3. the change from baseline to Week 6 on the HAM‐A in participants with a baseline HAM‐A score =20 ; 4. the change in the General Anxiety Disorder‐7 scale (GAD‐7) from baseline to Week 6. ; 5. the change in the Patient Health Questionnaire (PHQ‐9) from baseline to weeks 2, 4 and 6. ; 6. the change in HDRS17 from baseline to weeks 2 and 4. ; 7. safety and tolerability of adjunctive treatment with JNJ‐61393215 ; 8. plasma concentration of JNJ‐61393215 ; Timepoint(s) of evaluation of this end point: 1. Baseline, week 2 and 4 ; 2. Baseline and week 6 ; 3. Baseline and week 6 ; 4. Baseline and week 6 ; 5. Baseline, week 2, week 4 and week 6 ; 6. Baseline, week 2 and week 4 ; 7. All visits ; 8. baseline, 2, 4 and 6 weeks ; INCLUSION CRITERIA: 1. Male and female participants between 18 and 64 years of age, inclusive. 2. Participants must have a primary DSM‐5 diagnosis of MDD with anxious distress, as assessed by the MINI 7.0. Plus (with module for MDD with anxious distress). 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 the investigator considers MDD to be the primary diagnosis. Participants with Panic Disorder with or without agoraphobia may be included if the Panic Disorder diagnosis is primary. 3. Participants must have an IDS‐C30 total score =35 (moderate to severe depression) at screening, as confirmed by the SAFER independent rater. 4. Participant must have an IDS‐C30 score for item 26 or 27 (symptoms of somatic anxiety) =2 at screening, as confirmed by the SAFER ind