An Efficacy, Safety and Tolerability Study of JNJ-42165279 in Participants With Major Depressive Disorder With Anxious Distress
Condition: Depressive Disorder; Anxiety
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: JNJ-42165279; Placebo
Intervention description: JNJ-42165279 will be administered orally at a dose of 25 milligrams (mg) tablet once daily for 6 weeks.; Matching Placebo will be administered orally.
Intervention MeSH terms: JNJ-42165279
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 161.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Major Depressive Disorder; Depression; Anxiety symptoms; JNJ-42165279

Summary:

      The purpose of this study is to evaluate the efficacy and safety and tolerability of
      JNJ-42165279 in participants with major depressive disorder (MDD) with anxiety symptoms who
      have had inadequate response to treatment with a selective serotonin reuptake inhibitor
      (SSRI) or serotonergic/noradrenergic reuptake inhibitor (SNRI).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant must meet the Diagnostic and Statistical Manual of Mental Disorders-IV
             (DSM-IV) or 5 diagnostic criteria for major depressive disorder (MDD) with Anxious
             Distress

          -  Participants with a diagnosis of comorbid Generalized Anxiety Disorder, Social Anxiety
             Disorder, or Panic Disorder may be included, if the investigator considers MDD with
             Anxious Distress to be the primary diagnosis (confirmed by an independent central
             rater at screening)

          -  Participants must have been treated with an approved SSRI/SNRI antidepressants for at
             least 6 continuous weeks, validated by an independent central rater contracted by the
             sponsor

          -  A 17-item Hamilton Depression Rating Scale (HDRS17) total score greater than or equal
             to (>=)18 and a HDRS17 anxiety/somatization factor score >=7 at screening, assessed by
             a site rater and reviewed by an independent central rater on Day 1

          -  Participant must be willing and able to adhere to the prohibitions and restrictions

          -  Participant Body mass index (BMI = weight/height2) must be between 18 and 35 kilogram
             per square meter (kg/m^2) inclusive

        Exclusion Criteria:

          -  Has other psychiatric condition, including, but not limited to, MDD with psychotic
             features, bipolar disorder, obsessive-compulsive disorder, post-traumatic stress
             disorder, borderline personality disorder, eating disorder, or schizophrenia

          -  Has a length of current Major Depressive Episode (MDE) greater than (>) 6 months

          -  Has more than 1 failed antidepressant treatment of adequate dose and duration in the
             current MDE, Not including the inadequate response to the current selective serotonin
             reuptake inhibitor (SSRI) or serotonergic/noradrenergic reuptake inhibitor (SNRI)
             antidepressant

          -  Has initiated psychotherapy specific for MDD (such as cognitive behavioral,
             behavioral, or interpersonal therapy) for the current episode of depression within 6
             weeks prior to Screening

          -  Has a current or recent history of clinically significant suicidal ideation within the
             past 6 months, or a history of suicidal behavior within the past year