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

• Register: EUCTR
• Last refreshed on: 28 February 2019
• Main ID: EUCTR2015-002007-29-ES
• Date of registration: 05/10/2015
• Prospective Registration: Yes
• Primary sponsor: Janssen-Cilag International NV
• 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: 24/11/2015
• Target sample size: 140
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-002007-29
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 4
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

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

Contacts

• Name: Clinical Registry Group
• Affiliation: Janssen-Cilag International NV

• Name: Clinical Registry Group
• Affiliation: Janssen-Cilag International NV

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 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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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]

Intervention(s)

Product Name: JNJ42165279-AAA - tablet - 25 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: Not assigned
CAS Number: Not assigned
Other descriptive name: JNJ-42165279-AAA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Secondary Objective: ? To assess the efficacy of JNJ-42165279 on core symptoms of anxiety (HAM-A6).
? To assess the efficacy of JNJ-42165279 using dimensional analyses of both anxiety and depression (HDRS17 and SIGH-A).
? To assess the efficacy of JNJ-42165279 on the response and remission of depressive and anxiety symptoms (derived from HDRS17 and SIGH-A).
? To assess the plasma pharmacokinetic (PK) profile of JNJ-42165279 administered as once daily (qd) in male and female subjects with MDD with anxious distress using a population PK approach and explore its relationship with efficacy and safety parameters.

Primary end point(s): Change from Baseline to Endpoint on the Hamilton Depression Rating Scale (HDRS17) Total Score

Timepoint(s) of evaluation of this end point: Baseline and Week 6

Main Objective: The primary objective of this study is to evaluate the efficacy in terms of reduction of symptoms of depression and anxiety, as assessed by the change from baseline on a 17-item Hamilton Depression Rating Scale (HDRS17), and overall safety and tolerability of treatment with adjunctive JNJ-42165279 compared to placebo in subjects with MDD with anxiety symptoms who have had inadequate response to treatment with a selective serotonin reuptake inhibitor (SSRI) or serotonergic/noradrenergic reuptake inhibitor (SNRI).

Secondary Outcome(s)

Secondary end point(s): El cambio con respecto a la situación basal de la puntuación en la escala 1) Change from Baseline to Endpoint on the Hamilton Anxiety Rating scale (HAM-A6) Score
2) Change from Baseline to Endpoint on the SIGH-A (Structured Interview Guide of the Hamilton Anxiety Scale 14-item HAM-A) Total Score
3) Change from Baseline to Endpoint on the Hamilton Anxiety Rating scale (HAM-D6) Score
4) Change from Baseline to Endpoint in the Hamilton Depression Rating Scale (HDRS17) Anxiety/Somatization Factor Total Score
5) Number of Participants with a Hamilton Depression Rating Scale (HDRS17) Anxiety/Somatization Factor Score Greater than or equal to 7 at Week 6
6) Maximum Plasma Concentration (Cmax) of JNJ-42165279
7) Time to Reach the Maximum Plasma Concentration (Tmax) of JNJ-42165279
8) Area Under the Plasma Concentration-time Curve From Time Zero to Dosing Interval [AUC(0-t)]

Timepoint(s) of evaluation of this end point: 1) Baseline and Week 6
2) Baseline and Week 6
3) Baseline and Week 6
4) Baseline and Week 6
5) Week 6
6) Pre-dose and 2 to 4 hours post-dose on Day 14, 35, 63 and 77
7) Pre-dose and 2 to 4 hours post-dose on Day 14, 35, 63 and 77
8) Pre-dose and 2 to 4 hours post-dose on Day 14, 35, 63 and 77

Secondary ID(s)

42165279MDD2001

Source(s) of Monetary Support

Janssen Research & Development LLC

Ethics review

Status: Approved
Approval date:
Contact: