{"id":4166,"date":"2025-06-01T01:00:00","date_gmt":"2025-06-01T06:00:00","guid":{"rendered":"https:\/\/rhochistj.org\/RhoChiPost\/?p=4166"},"modified":"2025-09-29T06:10:42","modified_gmt":"2025-09-29T11:10:42","slug":"efficacy-of-a-novel-digital-therapeutic-targeting-negative-symptoms-in-schizophrenia","status":"publish","type":"post","link":"https:\/\/rhochistj.org\/RhoChiPost\/efficacy-of-a-novel-digital-therapeutic-targeting-negative-symptoms-in-schizophrenia\/","title":{"rendered":"Efficacy of a Novel Digital Therapeutic Targeting Negative Symptoms in Schizophrenia"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">By: Michelle Flores, PharmD Candidate c\/o 2027<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/strong>Schizophrenia impacts an estimated 24 million individuals globally, with roughly 60% of those affected experiencing negative symptoms. These symptoms, which are a cornerstone of the condition alongside positive symptoms and cognitive impairment, are divided into two categories: experiential and expressive. Experiential symptoms manifest as a lack of motivation (avolition), social withdrawal (asociality), and a reduced capacity for experiencing pleasure (anhedonia). In contrast, expressive symptoms are characterized by a decrease in emotional expression (blunted affect) and a reduction in speech (alogia). While medications are widely used to manage the broader symptoms of schizophrenia, no single treatment has yet been specifically approved by the U.S. regulatory authority for the exclusive indication of negative symptoms.<sup>1<\/sup><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Prescription digital therapeutics (PDTs) are increasingly being integrated into schizophrenia care, with clinicians prescribing them for use on smartphones to support patients in managing the behavioral challenges of their illness. Built to be intuitive and widely accessible, these technologies help overcome common barriers to mental health treatment, such as limited provider availability and financial constraints.<sup>3<\/sup> Because they can be tailored to individual needs, PDTs offer flexibility in how patients engage with them to maximize benefit. One such example, CT-155, is an investigational digital therapeutic designed to target the negative symptoms of schizophrenia when used alongside conventional pharmacological treatment.<sup>3<\/sup><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The CONVOKE trial (NCT05838625) was a phase III, multicenter, randomized, double-blind study conducted over 16 weeks. The trial evaluated the safety and efficacy of CT-155 against a digital control application, with both administered alongside standard antipsychotic treatment in patients with negative symptoms of schizophrenia.<sup>4<\/sup> The trial enrolled adults and older adolescents who were stable on their current antipsychotic regimen.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The primary endpoint measured changes in experiential negative symptoms from baseline to week 16, using the Motivation and Pleasure subscale of the Clinical Assessment Interview for Negative Symptoms (CAINS-MAP). Secondary outcomes included changes in CAINS-MAP scores at week 8, emotional expressivity assessed by the CAINS-EXP at weeks 8 and 16, and positive symptom severity measured with the Positive and Negative Syndrome Scale (PANSS) at both time points.<sup>4<\/sup> Additional assessments examined social functioning through the Personal and Social Performance Scale (PSP) and overall patient-reported improvement using the Patient Global Impression of Improvement (PGI-I) scale at weeks 8 and 16.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">According to Shaheen Lakhan, MD, PhD, FAAN, chief medical and scientific officer at Click Therapeutics, the CONVOKE trial delivers the first phase 3 evidence that a prescription digital therapeutic can enhance standard antipsychotic treatment by targeting one of schizophrenia\u2019s most challenging core features. He emphasized that the improvements in experiential negative symptoms- achieved without introducing new safety concerns- represent an important step forward in addressing a long-standing gap in care for patients living with schizophrenia.<sup>2<\/sup><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Pharmacists occupy a pivotal position in the integration of prescription digital therapeutics (PDTs) into the management of schizophrenia and other psychiatric disorders. Their responsibilities extend beyond facilitating patient access to these technologies; pharmacists play a critical role in monitoring adherence to both PDTs and concomitant antipsychotic therapy. In addition, pharmacists are well suited to evaluate potential safety concerns, including the possibility that digital interventions may exacerbate existing symptoms, thereby ensuring that PDT use remains clinically appropriate.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">As novel agents such as CT-155 progress through clinical development, it is essential that pharmacists and mental health professionals remain informed regarding their therapeutic potential and limitations. Notably, CT-155 was granted breakthrough device designation by the U.S. Food and Drug Administration in 2024, reflecting its potential to address a significant unmet need in schizophrenia care. Pending regulatory approval supported by the phase 3 CONVOKE trial, CT-155 could represent a meaningful advancement in adjunctive treatment, highlighting the expanding role of pharmacists in optimizing outcomes with emerging digital health technologies.<sup>3<\/sup><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">REFERENCES<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li>Boehringer and Click Therapeutics\u2019 investigational prescription digital therapeutic CT-155 meets primary endpoint in CONVOKE study for negative symptoms in schizophrenia. Boehringer. (2025, July 8). <a href=\"https:\/\/www.boehringer-ingelheim.com\/human-health\/mental-health\/schizophrenia\/phase-iii-convoke-study-meets-primary-endpoint\" target=\"new\" class=\"external external_icon\">https:\/\/www.boehringer-ingelheim.com\/human-health\/mental-health\/schizophrenia\/phase-iii-convoke-study-meets-primary-endpoint<\/a><\/li>\n\n\n\n<li>Ernst, D. (2025, August 15). Prescription digital therapeutic CT-155 promising for negative symptoms of schizophrenia. Neurology Advisor. <a href=\"https:\/\/www.neurologyadvisor.com\/news\/prescription-digital-therapeutic-ct-155-promising-for-negative-symptoms-of-schizophrenia\/\" target=\"new\" class=\"external external_icon\">https:\/\/www.neurologyadvisor.com\/news\/prescription-digital-therapeutic-ct-155-promising-for-negative-symptoms-of-schizophrenia\/<\/a><\/li>\n\n\n\n<li>Halpern, L. (2025, August 20). Novel prescription digital therapeutic improves negative symptoms of schizophrenia. Pharmacy Times. <a href=\"https:\/\/www.pharmacytimes.com\/view\/novel-prescription-digital-therapeutic-improves-negative-symptoms-of-schizophrenia\" target=\"new\" class=\"external external_icon\">https:\/\/www.pharmacytimes.com\/view\/novel-prescription-digital-therapeutic-improves-negative-symptoms-of-schizophrenia<\/a>\u00a0<\/li>\n\n\n\n<li>Kuntz, L. (2025, August 12). Investigational prescription digital therapeutic CT-155 for negative symptoms of schizophrenia meets primary study end point. Psychiatric Times. <a href=\"https:\/\/www.psychiatrictimes.com\/view\/investigational-prescription-digital-therapeutic-ct-155-for-negative-symptoms-of-schizophrenia-meets-primary-study-endpoint\" target=\"new\" class=\"external external_icon\">https:\/\/www.psychiatrictimes.com\/view\/investigational-prescription-digital-therapeutic-ct-155-for-negative-symptoms-of-schizophrenia-meets-primary-study-endpoint<\/a><\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"<p>By: Michelle Flores, PharmD Candidate c\/o 2027 &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Schizophrenia impacts an estimated 24 million individuals globally, with roughly 60% of those affected experiencing negative symptoms. These symptoms, which are a cornerstone of the condition alongside positive symptoms and cognitive impairment, are divided into two categories: experiential and expressive. Experiential symptoms manifest as a lack of&hellip;<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[5],"tags":[],"class_list":["post-4166","post","type-post","status-publish","format-standard","hentry","category-news-politics"],"views":55,"_links":{"self":[{"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/posts\/4166","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/comments?post=4166"}],"version-history":[{"count":1,"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/posts\/4166\/revisions"}],"predecessor-version":[{"id":4167,"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/posts\/4166\/revisions\/4167"}],"wp:attachment":[{"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/media?parent=4166"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/categories?post=4166"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/tags?post=4166"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}