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- | JNJ-42165279 / J&J
Phase classification: A Safety and Efficacy Study of JNJ-42165279 in Participants With Social Anxiety Disorder (clinicaltrials.gov) - Feb 12, 2025
P2, N=150, Completed, Sponsor: Janssen Research & Development, LLC
Phase classification: P2a --> P2
- | JNJ-42165279 / J&J
Phase classification: An Efficacy, Safety and Tolerability Study of JNJ-42165279 in Participants With Major Depressive Disorder With Anxious Distress (clinicaltrials.gov) - Feb 4, 2025
P2, N=161, Completed, Sponsor: Janssen Research & Development, LLC
Phase classification: P2a --> P2 Phase classification: P2a --> P2
- || JNJ-42165279 / J&J
Clinical, P2 data, Journal: Efficacy and safety of JNJ-42165279, a fatty acid amide hydrolase inhibitor, in adolescents and adults with autism spectrum disorder: a randomized, phase 2, placebo-controlled study. (Pubmed Central) - Dec 10, 2024
P2
JNJ-42165279 demonstrated an acceptable safety profile. Although primary endpoints were not met, JNJ-42165279 may have a therapeutic effect on certain aspects of core ASD symptoms.
- JNJ-42165279 / J&J
Effect of Pharmacological Elevation of Anandamide on Neural Functional Connectivity and Emotional Regulation in Patients with Post-Traumatic Stress Disorder (Griffin Hall) - Apr 14, 2024 - Abstract #SOBP2024SOBP_816;
Within the treatment group, there was a significant 3-way interaction between blood drug level, facial emotion, and congruence of trial in the vmPFC and parahippocampal gyrus. There were no significant differences in vmPFC-amygdala functional connectivity between the treatment and placebo groups.
- ||| JNJ-42165279 / J&J
Trial completion: Envision: A Study to Investigate the Efficacy, Safety, and Tolerability of JNJ-42165279 in Adolescent and Adult Participants With Autism Spectrum Disorder (clinicaltrials.gov) - Dec 8, 2022
P2, N=78, Completed, Sponsor: Janssen Research & Development, LLC
There were no significant differences in vmPFC-amygdala functional connectivity between the treatment and placebo groups. Active, not recruiting --> Completed
- || JNJ-42165279 / J&J
Enrollment closed: Envision: A Study to Investigate the Efficacy, Safety, and Tolerability of JNJ-42165279 in Adolescent and Adult Participants With Autism Spectrum Disorder (clinicaltrials.gov) - Sep 15, 2022
P2, N=78, Active, not recruiting, Sponsor: Janssen Research & Development, LLC
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- || JNJ-42165279 / J&J
Trial completion date, Trial primary completion date: Envision: A Study to Investigate the Efficacy, Safety, and Tolerability of JNJ-42165279 in Adolescent and Adult Participants With Autism Spectrum Disorder (clinicaltrials.gov) - Apr 28, 2022
P2, N=80, Recruiting, Sponsor: Janssen Research & Development, LLC
Recruiting --> Active, not recruiting Trial completion date: Jul 2022 --> Oct 2022 | Trial primary completion date: Mar 2022 --> Oct 2022
- | JNJ-42165279 / J&J
Preclinical, Journal: Exacerbation of Background Nuclear Cataracts in Sprague-Dawley Rats in Embryo-Fetal Development Studies With JNJ-42165279, a Fatty Acid Amide Hydrolase Inhibitor. (Pubmed Central) - Oct 1, 2021
No histologic correlates for these cataracts were identified. We conclude that fetal primary lens fiber hypertrophy and nuclear cataracts at ophthalmology, are common background changes in this rat strain that are exacerbated by in utero exposure to the FAAH inhibitor JNJ-42165279.
- || JNJ-42165279 / J&J
Clinical, Journal: The effects of inhibition of fatty acid amide hydrolase (FAAH) by JNJ-42165279 in social anxiety disorder: a double-blind, randomized, placebo-controlled proof-of-concept study. (Pubmed Central) - Jun 24, 2021
P2a
JNJ-42165279 appears to elicit an anxiolytic effect in subjects with SAD although trough concentrations with 25 mg once daily appeared to be insufficient to completely inhibit FAAH activity which may have led to suboptimal efficacy. ClinicalTrials.gov Identifier: NCT02432703.
- || JNJ-42165279 / J&J
Clinical, Journal: The effects of FAAH inhibition on the neural basis of anxiety-related processing in healthy male subjects: a randomized clinical trial. (Pubmed Central) - Jun 24, 2021
JNJ-42165279 did not affect fear conditioning or within-session extinction learning as evidenced by a lack of differences on a subjective and neural circuit level. Taken together, these results support the hypothesis that JNJ-42165279 at this dose shares some effects with existing anxiolytic agents in dampening response to emotional stimuli but not responses to conditioned fear.
- | BIA 10 2474 / Eisai
Preclinical, Journal: Preclinical pharmacological evaluation of the fatty acid amide hydrolase inhibitor BIA 10-2474. (Pubmed Central) - Jun 22, 2021
BIA 10-2474 potently inhibits FAAH in vivo, similarly to PF-04457845, but also interacts with a number of lipid processing enzymes, some previously identified in human cells as off-targets particularly at high levels of exposure. These interactions occurred at doses used in toxicology studies, but the implication of these off-targets in the clinical trial accident remains unclear.
- | JNJ-42165279 / J&J
Trial completion date: Envision: A Study to Investigate the Efficacy, Safety, and Tolerability of JNJ-42165279 in Adolescent and Adult Participants With Autism Spectrum Disorder (clinicaltrials.gov) - May 28, 2021
P2, N=80, Recruiting, Sponsor: Janssen Research & Development, LLC
These interactions occurred at doses used in toxicology studies, but the implication of these off-targets in the clinical trial accident remains unclear. Trial completion date: Nov 2022 --> Jun 2022
- | JNJ-42165279 / J&J
Trial completion date: Envision: A Study to Investigate the Efficacy, Safety, and Tolerability of JNJ-42165279 in Adolescent and Adult Participants With Autism Spectrum Disorder (clinicaltrials.gov) - Dec 14, 2020
P2, N=80, Recruiting, Sponsor: Janssen Research & Development, LLC
Trial completion date: Nov 2022 --> Jun 2022 Trial completion date: May 2022 --> Sep 2022
- | JNJ-42165279 / J&J
Enrollment change, Trial primary completion date: Envision: A Study to Investigate the Efficacy, Safety, and Tolerability of JNJ-42165279 in Adolescent and Adult Participants With Autism Spectrum Disorder (clinicaltrials.gov) - May 6, 2020
P2, N=80, Recruiting, Sponsor: Janssen Research & Development, LLC
Trial completion date: May 2022 --> Sep 2022 N=60 --> 80 | Trial primary completion date: Aug 2021 --> Mar 2022
- | JNJ-42165279 / J&J
Trial completion date: Envision: A Study to Investigate the Efficacy, Safety, and Tolerability of JNJ-42165279 in Adolescent and Adult Participants With Autism Spectrum Disorder (clinicaltrials.gov) - Feb 10, 2020
P2, N=60, Recruiting, Sponsor: Janssen Research & Development, LLC
N=60 --> 80 | Trial primary completion date: Aug 2021 --> Mar 2022 Trial completion date: Oct 2021 --> Mar 2022
- | JNJ-42165279 / J&J
Trial primary completion date: Envision: A Study to Investigate the Efficacy, Safety, and Tolerability of JNJ-42165279 in Adolescent and Adult Participants With Autism Spectrum Disorder (clinicaltrials.gov) - Nov 20, 2019
P2, N=60, Recruiting, Sponsor: Janssen Research & Development, LLC
Trial completion date: Oct 2021 --> Mar 2022 Trial primary completion date: Feb 2021 --> Aug 2021
- JNJ-42165279 / J&J
A Phase 2a Randomized, Double-Blind, Placebo-Controlled Study Investigating the Efficacy, Safety, and Tolerability of the Fatty Acid Amide Hydrolase (FAAH) Inhibitor JNJ-42165279 in Subjects With Social Anxiety Disorder (Floridian Ballroom) - Oct 17, 2019 - Abstract #ACNP2019ACNP_644;
This was substantially less and later than the effect reported for SSRIs and venlafaxine. The strong relationship between plasma AEA levels and trough concentrations of JNJ-42165279 suggest that escape from full FAAH inhibition occurred in subjects with lower trough concentrations.
- JNJ-42165279 / J&J
A Phase 2a Randomized, Double-Blind, Placebo-Controlled Study Investigating the Efficacy and Safety of Adjunct Treatment With the FAAH Inhibitor JNJ-42165279 in Subjects With Major Depressive Disorder With Anxious Distress (Floridian Ballroom) - Oct 17, 2019 - Abstract #ACNP2019ACNP_277;
These subjects may have had a strong expectation bias on the value of an experimental treatment, were responding to their standard treatments in the context of frequent clinic visits, or were recovering from their MDD episode. We did not identify significant therapeutic effects of 25 mg JNJ-42165279 per day for 6 weeks as an adjunct treatment for MDD with anxious distress.
- | JNJ-42165279 / J&J
Trial completion date: Envision: A Study to Investigate the Efficacy, Safety, and Tolerability of JNJ-42165279 in Adolescent and Adult Participants With Autism Spectrum Disorder (clinicaltrials.gov) - Sep 22, 2019
P2, N=60, Recruiting, Sponsor: Janssen Research & Development, LLC
We did not identify significant therapeutic effects of 25 mg JNJ-42165279 per day for 6 weeks as an adjunct treatment for MDD with anxious distress. Trial completion date: Mar 2021 --> Aug 2021
- | JNJ-42165279 / J&J
Clinical, Journal: Fatty Acid Amide Hydrolase Inhibition by JNJ-42165279: A Multiple-Ascending Dose and a Positron Emission Tomography Study in Healthy Volunteers. (Pubmed Central) - Jul 17, 2019
Saturation of brain FAAH occupancy occurred with doses ≥10 mg of JNJ-42165279. No safety concerns were identified.
- | JNJ-42165279 / J&J
Trial completion: An Efficacy, Safety and Tolerability Study of JNJ-42165279 in Participants With Major Depressive Disorder With Anxious Distress (clinicaltrials.gov) - Mar 5, 2019
P2a, N=161, Completed, Sponsor: Janssen Research & Development, LLC
No safety concerns were identified. Active, not recruiting --> Completed
- | JNJ-42165279 / J&J
Enrollment closed: An Efficacy, Safety and Tolerability Study of JNJ-42165279 in Participants With Major Depressive Disorder With Anxious Distress (clinicaltrials.gov) - Nov 20, 2018
P2a, N=161, Active, not recruiting, Sponsor: Janssen Research & Development, LLC
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- | JNJ-42165279 / J&J
Enrollment open: Envision: A Study to Investigate the Efficacy, Safety, and Tolerability of JNJ-42165279 in Adolescent and Adult Participants With Autism Spectrum Disorder (clinicaltrials.gov) - Nov 20, 2018
P2, N=60, Recruiting, Sponsor: Janssen Research & Development, LLC
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- | JNJ-42165279 / J&J
Trial completion date, Trial primary completion date: An Efficacy, Safety and Tolerability Study of JNJ-42165279 in Participants With Major Depressive Disorder With Anxious Distress (clinicaltrials.gov) - Oct 23, 2018
P2a, N=143, Recruiting, Sponsor: Janssen Research & Development, LLC
Not yet recruiting --> Recruiting Trial completion date: Jun 2019 --> Mar 2019 | Trial primary completion date: Aug 2018 --> Feb 2019
- | JNJ-42165279 / J&J
Trial completion: A Single and Multiple Dose Study to Investigate Safety, Tolerability and Pharmacokinetics of JNJ-42165279 in Healthy Japanese Male Participants (clinicaltrials.gov) - Oct 9, 2018
P1, N=12, Completed, Sponsor: Janssen Research & Development, LLC
Trial completion date: Jun 2019 --> Mar 2019 | Trial primary completion date: Aug 2018 --> Feb 2019 Recruiting --> Completed
- | JNJ-42165279 / J&J
Trial completion: A Safety and Efficacy Study of JNJ-42165279 in Participants With Social Anxiety Disorder (clinicaltrials.gov) - Sep 24, 2018
P2a, N=150, Completed, Sponsor: Janssen Research & Development, LLC
Recruiting --> Completed Active, not recruiting --> Completed
- | JNJ-42165279 / J&J
New P2 trial: Envision: A Study to Investigate the Efficacy, Safety, and Tolerability of JNJ-42165279 in Adolescent and Adult Participants With Autism Spectrum Disorder (clinicaltrials.gov) - Sep 9, 2018
P2, N=60, Not yet recruiting, Sponsor: Janssen Research & Development, LLC
- | JNJ-42165279 / J&J
Enrollment closed: A Safety and Efficacy Study of JNJ-42165279 in Participants With Social Anxiety Disorder (clinicaltrials.gov) - Jul 30, 2018
P2a, N=150, Active, not recruiting, Sponsor: Janssen Research & Development, LLC
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- || JNJ-42165279 / J&J
Enrollment open: A Single and Multiple Dose Study to Investigate Safety, Tolerability and Pharmacokinetics of JNJ-42165279 in Healthy Japanese Male Participants (clinicaltrials.gov) - Jul 2, 2018
P1, N=12, Recruiting, Sponsor: Janssen Research & Development, LLC
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- || JNJ-42165279 / J&J
New P1 trial: A Single and Multiple Dose Study to Investigate Safety, Tolerability and Pharmacokinetics of JNJ-42165279 in Healthy Japanese Male Participants (clinicaltrials.gov) - Jun 19, 2018
P1, N=12, Not yet recruiting, Sponsor: Janssen Research & Development, LLC
- || JNJ-42165279 / J&J
Trial completion date: An Efficacy, Safety and Tolerability Study of JNJ-42165279 in Participants With Major Depressive Disorder With Anxious Distress (clinicaltrials.gov) - Mar 3, 2018
P2a, N=140, Recruiting, Sponsor: Janssen Research & Development, LLC
Not yet recruiting --> Recruiting Trial completion date: Apr 2019 --> Jun 2019
- |||| JNJ-42165279 / J&J
Enrollment open: An Efficacy, Safety and Tolerability Study of JNJ-42165279 in Participants With Major Depressive Disorder With Anxious Distress (clinicaltrials.gov) - Nov 13, 2017
P2a, N=140, Recruiting, Sponsor: Janssen Research & Development, LLC
Trial completion date: Apr 2019 --> Jun 2019 Suspended --> Recruiting
- || JNJ-42165279 / J&J
Trial primary completion date: A Safety and Efficacy Study of JNJ-42165279 in Participants With Social Anxiety Disorder (clinicaltrials.gov) - Jun 4, 2017
P2a, N=122, Recruiting, Sponsor: Janssen Research & Development, LLC
Suspended --> Recruiting Trial primary completion date: Apr 2018 --> Jul 2018
- |||| JNJ-42165279 / J&J
Enrollment open: A Safety and Efficacy Study of JNJ-42165279 in Participants With Social Anxiety Disorder (clinicaltrials.gov) - Feb 9, 2017
P2a, N=122, Recruiting, Sponsor: Janssen Research & Development, LLC
Trial primary completion date: Apr 2018 --> Jul 2018 Not yet recruiting --> Recruiting
- JNJ-42165279 / J&J
Trial primary completion date: An Efficacy, Safety and Tolerability Study of JNJ-42165279 in Participants With Major Depressive Disorder With Anxious Distress (clinicaltrials.gov) - Nov 1, 2016
P2a, N=140, Suspended, Sponsor: Janssen Research & Development, LLC
Not yet recruiting --> Recruiting Trial primary completion date: Jun 2017 --> Aug 2018
- JNJ-42165279 / J&J
Trial primary completion date: A Safety and Efficacy Study of JNJ-42165279 in Participants With Social Anxiety Disorder (clinicaltrials.gov) - Oct 31, 2016
P2a, N=122, Suspended, Sponsor: Janssen Research & Development, LLC
Trial primary completion date: Jun 2017 --> Aug 2018 Trial primary completion date: Feb 2017 --> Apr 2018
- JNJ-42165279 / J&J
Phase classification: An Efficacy, Safety and Tolerability Study of JNJ-42165279 in Participants With Major Depressive Disorder With Anxious Distress (clinicaltrials.gov) - Sep 20, 2016
P2a, N=140, Suspended, Sponsor: Janssen Research & Development, LLC
Trial primary completion date: Feb 2017 --> Apr 2018 Phase classification: P2 --> P2a
- JNJ-42165279 / J&J
Phase classification: A Safety and Efficacy Study of JNJ-42165279 in Participants With Social Anxiety Disorder (clinicaltrials.gov) - Sep 20, 2016
P2a, N=122, Suspended, Sponsor: Janssen Research & Development, LLC
Phase classification: P2 --> P2a Phase classification: P2 --> P2a
- | JNJ-42165279 / J&J
Trial suspension: An Efficacy, Safety and Tolerability Study of JNJ-42165279 in Participants With Major Depressive Disorder With Anxious Distress (clinicaltrials.gov) - Jan 25, 2016
P2, N=140, Suspended, Sponsor: Janssen Research & Development, LLC
Phase classification: P2 --> P2a Recruiting --> Suspended
- | JNJ-42165279 / J&J
Trial suspension: A Safety and Efficacy Study of JNJ-42165279 in Participants With Social Anxiety Disorder (clinicaltrials.gov) - Jan 25, 2016
P2, N=122, Suspended, Sponsor: Janssen Research & Development, LLC
Recruiting --> Suspended Recruiting --> Suspended
- |||| JNJ-42165279 / J&J
Enrollment open: An Efficacy, Safety and Tolerability Study of JNJ-42165279 in Participants With Major Depressive Disorder With Anxious Distress (clinicaltrials.gov) - Nov 17, 2015
P2, N=140, Recruiting, Sponsor: Janssen Research & Development, LLC
Recruiting --> Suspended Not yet recruiting --> Recruiting
- | JNJ-42165279 / J&J
New P2 trial: An Efficacy, Safety and Tolerability Study of JNJ-42165279 in Participants With Major Depressive Disorder With Anxious Distress (clinicaltrials.gov) - Jul 15, 2015
P2, N=140, Not yet recruiting, Sponsor: Janssen Research & Development, LLC
- JNJ-42165279 / J&J
Enrollment open: A Safety and Efficacy Study of JNJ-42165279 in Participants With Social Anxiety Disorder (clinicaltrials.gov) - Jul 6, 2015
P2, N=122, Recruiting, Sponsor: Janssen Research & Development, LLC
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- ||||| JNJ-42165279 / J&J
New P2 trial: A Safety and Efficacy Study of JNJ-42165279 in Participants With Social Anxiety Disorder (clinicaltrials.gov) - May 4, 2015
P2, N=122, Not yet recruiting, Sponsor: Janssen Research & Development, LLC
- | JNJ-42165279 / J&J
Trial completion, Enrollment change: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-42165279 in Healthy Young and Elderly Participants (clinicaltrials.gov) - Dec 5, 2014
P1, N=40, Completed, Sponsor: Janssen Research & Development, LLC
Not yet recruiting --> Recruiting Recruiting --> Completed | N=32 --> 40
- | JNJ-42165279 / J&J
Trial completion: The Effects of JNJ-42165279 on the Neural Basis of Anxiety Disorders in Healthy Male Volunteers (clinicaltrials.gov) - Oct 17, 2014
P1, N=43, Completed, Sponsor: Janssen Research & Development, LLC
Recruiting --> Completed | N=32 --> 40 Recruiting --> Completed
- | JNJ-42165279 / J&J
Trial completion, Enrollment change: A Study to Investigate the Regional Brain Kinetics of the Positron Emission Tomography Ligand 11C-MK-3168 and the Blocking of the Retention of the Ligand in the Human Brain by JNJ-42165279 (clinicaltrials.gov) - Sep 28, 2014
P1, N=15, Completed, Sponsor: Janssen Research & Development, LLC
Recruiting --> Completed Recruiting --> Completed | N=25 --> 15
- JNJ-42165279 / J&J
Enrollment open, Trial primary completion date: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-42165279 in Healthy Young and Elderly Participants (clinicaltrials.gov) - Aug 29, 2014
P1, N=32, Recruiting, Sponsor: Janssen Research & Development, LLC
Recruiting --> Completed | N=25 --> 15 Completed --> Recruiting | Trial primary completion date: Feb 2014 --> Oct 2014
- | JNJ-42165279 / J&J
New P1 trial: A Study to Investigate the Regional Brain Kinetics of the Positron Emission Tomography Ligand 11C-MK-3168 and the Blocking of the Retention of the Ligand in the Human Brain by JNJ-42165279 (clinicaltrials.gov) - Jun 24, 2014
P1, N=25, Recruiting, Sponsor: Janssen Research & Development, LLC
- JNJ-42165279 / J&J
Trial primary completion date: The Effects of JNJ-42165279 on the Neural Basis of Anxiety Disorders in Healthy Male Volunteers (clinicaltrials.gov) - Jun 22, 2014
P1, N=40, Recruiting, Sponsor: Janssen Research & Development, LLC
Completed --> Recruiting | Trial primary completion date: Feb 2014 --> Oct 2014 Trial primary completion date: May 2014 --> Aug 2014