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

• Register: ClinicalTrials.gov
• Last refreshed on: 21 November 2022
• Main ID: NCT02498392
• Date of registration: 13/07/2015
• Prospective Registration: Yes
• Primary sponsor: Janssen Research & Development, LLC
• Public title: An Efficacy, Safety and Tolerability Study of JNJ-42165279 in Participants With Major Depressive Disorder With Anxious Distress
• Scientific title: A Phase 2a Randomized, Double-blind, Placebo-Controlled, Parallel-Group, Multi-center Study Investigating the Efficacy, Safety, and Tolerability of JNJ-42165279 in Subjects With Major Depressive Disorder With Anxious Distress
• Date of first enrolment: October 7, 2015
• Target sample size: 161
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02498392
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Moldova, Republic of, Romania, Russian Federation, Spain, Ukraine, United Kingdom, United States

Contacts

• Name: Janssen Research & Development, LLC Clinical Trial
• Affiliation: Janssen Research & Development, LLC

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 64 Years
Gender: All

Health Condition(s) or Problem(s) studied

Anxiety

Depressive Disorder

Intervention(s)

Other: Placebo

Drug: JNJ-42165279

Primary Outcome(s)

Double-blind Treatment Period: Change From Baseline in HDRS17 Total Score at Week 6 (fITT Population) [Time Frame: Baseline and Week 6]

Double-blind Treatment Period: Change From Baseline in Hamilton Depression Rating Scale (HDRS17) Total Score at Week 6 (eITT Population) [Time Frame: Baseline and Week 6]

Secondary Outcome(s)

Double-blind Treatment Period: Change From Baseline in Structured Interview Guide of the Hamilton Anxiety Scale (SIGH-A) Total Score at Week 6 (eITT Population) [Time Frame: Baseline and Week 6]

Double-blind Treatment Period: Percentage of Participants With Greater Than or Equal to (>=) 30 Percent (%) Improvement on the HDRS17 Total Score at Week 6 (eITT Population) [Time Frame: Week 6]

Double-blind Treatment Period: Change From Baseline in the HDRS17 Anxiety/Somatization Factor Total Score at Week 6 (eITT Population) [Time Frame: Baseline and Week 6]

Double-blind Treatment Period: Change From Baseline in Hamilton Anxiety Rating Subscale (HAM-A6) Score at Week 6 (eITT Population) [Time Frame: Baseline and Week 6]

Double-blind Treatment Period: Percentage of Participants With a Clinical Global Impression Improvement (CGI-I) Score of Very Much Improved or Much Improved at Week 6 (fITT Population) [Time Frame: Week 6]

Double-blind Treatment Period: Percentage of Participants With >= 30% Improvement on SIGH-A Total Score at Week 6 (fITT Population) [Time Frame: Week 6]

Double-blind Treatment Period: Percentage of Participants With >= 50% Improvement in the HDRS17 Total Score at Week 6 (eITT Population) [Time Frame: Week 6]

Double-blind Treatment Period: Change From Baseline in the HDRS17 Anxiety/Somatization Factor Total Score at Week 6 (fITT Population) [Time Frame: Baseline and Week 6]

Double-blind Treatment Period: Percentage of Participants With Remission as Assessed by HDRS17 Total Score Less Than or Equal to (<=) 7 at Week 6 (eITT Population) [Time Frame: Week 6]

Double-blind Treatment Period: Change From Baseline in SIGH-A Total Score at Week 6 (fITT Population [Time Frame: Baseline and Week 6]

Double-blind Treatment Period: Percentage of Participants With >= 50% Improvement in the HDRS17 Total Score at Week 6 (fITT Population) [Time Frame: Week 6]

Double-blind Treatment Period: Percentage of Participants With Remission as Assessed by HDRS17 Total Score <= 7 at Week 6 (fITT Population) [Time Frame: Week 6]

Time to Reach the Maximum Plasma Concentration (Tmax) of JNJ-42165279 [Time Frame: Pre-dose, 2 to 4 hours post-dose on Days 14, 35, 63, and 77]

Double-blind Treatment Period: Change From Baseline in HAM-A6 Score at Week 6 (fITT Population) [Time Frame: Baseline and Week 6]

Double-blind Treatment Period: Change From Baseline in HAM-D6 Score at Week 6 (fITT Population) [Time Frame: Baseline and Week 6]

Double-blind Treatment Period: Change From Baseline in Hamilton Depression Rating Subscale (HAM-D6) Score at Week 6 (eITT Population) [Time Frame: Baseline and Week 6]

Double-blind Treatment Period: Percentage of Participants With >= 50% Improvement on SIGH-A Total Score at Week 6 (fITT Population) [Time Frame: Week 6]

Double-blind Treatment Period: Percentage of Participants With >= 30% Improvement on SIGH-A Total Score at Week 6 (eITT Population) [Time Frame: Week 6]

Area Under the Plasma Concentration-time Curve From Zero to Dosing Intervals (AUC[0-tau]) of JNJ-42165279 [Time Frame: Pre-dose, 2 to 4 hours post-dose on Days 14, 35, 63, and 77]

Double-blind Treatment Period: Percentage of Participants With >= 50% Improvement on SIGH-A Total Score at Week 6 (eITT Population) [Time Frame: Week 6]

Double-blind Treatment Period: Percentage of Participants With >= 30 % Improvement on the HDRS17 Total Score at Week 6 (fITT Population) [Time Frame: Week 6]

Double-blind Treatment Period: Percentage of Participants With a Clinical Global Impression Improvement (CGI-I) Score of Very Much Improved or Much Improved at Week 6 (eITT Population) [Time Frame: Week 6]

Maximum Plasma Concentration (Cmax) of JNJ-42165279 [Time Frame: Pre-dose, 2 to 4 hours post-dose on Days 14, 35, 63, and 77]

Secondary ID(s)

42165279MDD2001

2015-002007-29

CR107733

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 07/04/2022
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02498392