An Efficacy, Safety and Tolerability Study of JNJ-42165279 in Participants with Major Depressive Disorder with Anxious Distress

Phase 1

• Conditions: Major Depressive Disorder Anxiety; MedDRA version: 18.0 Level: LLT Classification code 10025453 Term: Major depressive disorder NOS System Organ Class: 100000004873; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2015-002007-29-ES
• Lead Sponsor: Janssen-Cilag International NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-05
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 140

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 antidepressant for at least 6 continuous weeks, validated by and independant 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/m2)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 140
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified