Efficacy & Safety of JNJ-42165279 in Subjects with MDD & Anxiety
Research type
Research Study
Full 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
IRAS ID
235567
Contact name
Aliya Asher
Contact email
Sponsor organisation
Janssen
Eudract number
2015-002007-29
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 4 months, 10 days
Research summary
This research study is being carried out by a Sponsor company called "Janssen Research & Development". The drug that is being studied is called JNJ-42165279. JNJ-42165279 is a new drug which inhibits (prevents the action of) an enzyme (type of protein) called 'FAAH' which normally is responsible for the breakdown of another protein called FAA. The drug may be useful for the treatment of mood disorders, such as Major Depressive Disorder (MDD) and anxiety. Sufferers of MDD suffer low mood that is present in a range of different situations and sufferers often experience low self-esteem and loss of interest in activities.
The purpose of this research study is to find out how well JNJ-42165279 works in reducing symptoms of depression and anxiety in subjects who have not responded well to other antidepressant treatments called selective serotonin reuptake inhibitors (SSRIs) and Serotonergic/noradrenergic reuptake inhibitor (SNRIs). The treatment will be taken for a period of 6 weeks and will be taken in addition to the subject’s regular permitted anti-depressant. In addition, this study aims to find out how safe the drug is (by looking at side effects) and how it is absorbed and processed by the body.
The length of participation in this study is approximately 14 to 18 weeks and it will involve a total of 11 study visits. As part of this study, participants will undergo, physical and neurological assessments, blood and urine sampling for laboratory analysis, ECGs and on-site assessments completed by a qualified clinician in the form of rating scales and questions relating to their condition. Some of these assessments at the beginning of the study will determine if a subject is eligible to participate. Patients will be asked to will be asked to complete a variety of self-assessment questionnaires at multiple visits throughout the study.
REC name
Wales REC 2
REC reference
17/WA/0365
Date of REC Opinion
23 Nov 2017
REC opinion
Unfavourable Opinion