The Effects of JNJ-42165279 on the Neural Basis of Anxiety Disorders in Healthy Male Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: JNJ-42165279 (100 mg); Drug: Placebo

• Registration Number: NCT01826786
• Lead Sponsor: Janssen Research & Development, LLC

Brief Summary

The purpose of this study is to evaluate the potential efficacy of JNJ-42165279 in treating anxiety disorders through evaluation of brain activation patterns using imaging technology in healthy volunteers.

Detailed Description

This is a single site, double-blind (neither investigator nor the participant knows the treatment that the participant receives) study. The study will consist of a screening phase (1-2 visits), a treatment phase (4 visits), and a post treatment phase (follow-up safety visit, 7 to 14 days after the last dose of the study drug). During the screening phase, participants will be evaluated to determine if they meet the study eligibility criteria, which will include collection of blood and urine samples. During the treatment phase, eligible participants will be assigned by chance (like a toss of a coin) to receive either JNJ-42165279 100 mg or placebo once daily during 4 consecutive visits to the clinic. Placebo is an inactive substance that is compared with a drug to test whether the drug has a real effect. The potential of the drug to treat anxiety will be assessed on Day 4 of the treatment phase. The primary assessment, Blood Oxygen Level Dependent Functional Magnetic Resonance Imaging (BOLD-fMRI), will measure brain activity patterns while participants complete 3 emotionally-provoking tasks. Additionally, participants' startle responses (eye blinks) will be evaluated in two emotionally-provoking behavioral tasks outside of the scanner. Questionnaires will be completed to evaluate participants' mood, and blood samples will be collected to measure concentrations of JNJ-42165279 and biomarkers of drug activity.

Safety will be monitored throughout the study, including adverse events, vital signs (blood pressure and heart rate), 12-lead ECGs, physical examinations, clinical safety laboratories, evaluation of suicidal risk, and a Walk and Turn test. The total study duration will be approximately 46 days.

Study Timeline

• Study First Submitted: 2013-04-04
• Study First Submitted QC: 2013-04-04
• Study First Posted: 2013-04-09
• Study Start: 2013-08
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-14
• Last Update Posted: 2014-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 43

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
JNJ-42165279 (100 mg)	JNJ-42165279 (100 mg)	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Brain activity patterns in the amygdala (almond-shaped part of the brain associated with motivation and emotional behavior)	Day 4	BOLD-fMRI percent signal changes during an Emotional Face Processing task.

Secondary Outcome Measures

Name	Time	Method
Brain activity patterns in multiple areas of the emotional brain neurocircuitry	Day 4	BOLD-fMRI percent signal changes during emotionally-provoking tasks (pictures of emotional faces, periods of breathing restriction, presentations of a loud noise).
Startle response	Day 4	Eye blink responses to a loud noise during 2 emotionally-provoking tasks outside of the MRI scanner.
The number of volunteers who experience adverse events as a measure of safety and tolerability.	Day -28 to Day 18