1– 4 Advances in research provide unprecedented opportunities to meet this pressing need. This study supports proceeding with assessment of the clinical impact of target engagement and serves as a model for implementing “Fast-Fail”.Ĭlinical trials document the limited effectiveness of currently available medications for mood and anxiety spectrum disorders and speak to the need for new treatments. JNJ-67953964, generally well-tolerated, was not associated with any serious adverse events. JNJ-67953964 significantly increased fMRI ventral striatum activation during reward anticipation (primary outcome) compared with placebo (Baseline-Adjusted Means: JNJ-67953964 0.72 Placebo 0.33, F(1,86)=5.58 p<0.01 Effect-Size=0.58).
#Primefiles avg trial#
This 8-week, double-blind, placebo-controlled, randomized (selective KOR antagonist and placebo ), parallel-group trial including patients with anhedonia and a mood/anxiety disorder was carried out in 6 academic centers.
This first comprehensive application of “Fast-Fail” evaluated the potential of kappa opioid receptor (KOR) antagonism for treating anhedonia with a POM study determining if robust target engagement favorably impacts brain circuitry hypothesized to mediate clinical effects. The NIMH “Fast-Fail” approach seeks to improve too-often misleading early phase drug development methods by incorporating biomarker-based “Proof-of-Mechanism” (POM) testing in Phase-IIa. RSEK contributed to designing the study, provided data quality oversight, and contributed to writing the manuscript.ĭI, SS, GH and KG participated in recruiting subjects, completing all protocol-specified study procedures including data collection with the subjects and contributed to writing the manuscript. HY served as statistician for the study, contributing to study design, carrying out data analysis, and contributing to writing the manuscript. RDW and JNJJr provided oversight for a study site where they led efforts in training and managing study personnel, recruiting subjects, completing all protocol-specified study procedures including data collection with the subjects and contributed to writing the manuscript.ĪS and MS provided oversight for collection and analysis of the MRI data and contributed to writing the manuscript.
SJM, SHL, JRC, GS, and WG contributed to designing the study, provided oversight for a study site where they led efforts in training and managing study personnel, recruiting subjects, completing all protocol-specified study procedures including data collection with the subjects and contributed to writing the manuscript. WZP provided critical intellectual input for designing the study and contributed to writing the manuscript.ĭAP provided critical intellectual input for designing the study, provided training, oversight and data analysis for the aspects of the study related to the behavioral tests and co-wrote the manuscript.ĪEW provided training, oversight, and data analysis for the aspects of the study related to the behavioral tests AUTHOR CONTRIBUTIONSADK designed the study, provided oversight for all aspects of the study, analyzed the data, and wrote the manuscript.
0 kommentar(er)
