CLICK THERAPEUTICS, INC. — Department of Health and Human Services SBIR Phase I: 104

Description

PROJECT SUMMARY Major Depressive DisorderMDDis a serioushighly prevalent illness in youthaffecting more thanof adolescents in the United StatesDespite important advances in the treatment of depressionthe majority of adolescents remain untreatedinadequately treated or cannot tolerate an adequate course of treatmentAs MDD continues to pose a significant public health problemwell tolerated new interventions are necessaryThe main objective of this Phase I research program is to develop a smartphone applicationCTathat is effective in treating adolescent depression and addresses many of the current barriers to effective treatmentincluding lack of qualified mental health practitionersperceived stigmapharmacological side effectsand concerns about costaccessibilityand confidentialityCTa builds upon Click TherapeuticsCTa new class of digital therapeutic interventions which focus on neural models of psychological dysfunctionCTcombines a cognitive emotional training interventionEmotional Faces Memory TaskEFMTand psychotherapeutic text messagingdelivered as a mobile application on Click s clinically validated Neurobehavioral Intervention PlatformThe Emotional Face Memory Task targets an imbalance in activity in specific regions of the brainthe limbic systemamygdalainvolved in emotion processingand PFC regionsDLPFC and VLPFCinvolved in cognitive control and cognitive reappraisal of emotionEFMT utilizes working memory and facial affect identification tasks to modulate amygdalaprefrontal cortex connectivityenhancing control of emotional processing informationand in adult clinical trials has shown the potential to rebalance functioning between these neural nodes and reduce MDD symptomsThe proposed project will adapt this highly innovative therapeutic intervention for use with adolescentsThis will require development and testing of adolescent appropriate content to complete a CTa prototypeUpon successful completion of this projectwe will seek rigorous clinical evidence for efficacy and safety in Phase IInecessary for successful commercialization in the digital therapeutics marketCTa s innovative delivery through a smartphone has the potential to significantly expand access to treatmentoffering adolescentsthe vast majority of whom have smartphone accessa low costconfidentialevidence based therapeutic intervention with a very favorable safety profile that can be prescribed across clinical settingswhere early signs of depression are often identified PROJECT NARRATIVE Developing well tolerated new treatment interventions are of critical importance for the three million adolescents diagnosed with MDDin the United Statesthe majority of whom remain untreated due to a lack of qualified mental health practitionersmedication intoleranceperceived stigma and concerns about costaccessibility and confidentialityamong othersGiven clinical trials of the CTdigital therapeutic for adult MDD have proven effective in rebalancing activation patterns of key brain regions involved in MDD and reducing depressive symptomsthe proposed research seeks to develop an adolescent version of CTCTa