An investigational prescription digital therapeutic demonstrated in a phase 3 trial that it could reduce the negative symptoms of schizophrenia.
In the trial, CT-155, which is being developed by Boehringer Ingelheim and Click Therapeutics, is being used as an adjunct to standard-of-care antipsychotic therapy in people diagnosed and living with schizophrenia experiencing negative symptoms.
An estimated 24 million worldwide have schizophrenia, according to the World Health Organization. People with schizophrenia have persistent delusions and hallucinations. Up to 60% of people with schizophrenia have negative symptoms, which include an inability to feel pleasure, having a flat affect or other speech problems and often lacking motivation.
Current medications, however, are not approved to treat the negative symptoms, which lead to impairment in day-to-day functioning. CT-155 is a smartphone app developed by Click Therapeutics that aims to address the behavioral dimensions of conditions such as schizophrenia. It uses AI-based technology to engage patients and help them manage their symptoms. CT-155 was granted breakthrough device designation in January 2024.
Emmanuelle Clerisme-Beaty, M.D.
“Although treatments are being used to help manage negative symptoms, there are no U.S. regulatory authority-approved treatments indicated for the negative symptoms of schizophrenia to date. This is one of the largest unmet needs for these patients and those who care for them,” Emmanuelle Clerisme-Beaty, M.D., medical director of US and senior vice president of medicine at Boehringer Ingelheim Pharmaceuticals, said in a news release.
In the CONVOKE study, CT-155 along with standard of care was compared with a digital control app as an adjunct to standard of care antipsychotic therapy to assess safety and efficacy. The trial enrolled 464 patients who were stable on antipsychotic medications.
CT-155 was well tolerated and demonstrated a favorable safety profile consistent with past studies. It met the primary endpoint of change in experiential negative symptoms from baseline to week 16 as measured by the Clinical Assessment Interview for Negative Symptoms, Motivation and Pleasure Scale. This scale is a semi-structured interview given by clinicians to assess motivation and pleasure in patients with schizophrenia. It has been demonstrated to be a reliable and valid rating scale for assessing negative symptoms.
Detailed results will be presented during the Novel Therapeutics Symposium on Monday, Oct. 13, 2025, at the 38th Annual European College of Neuropsychopharmacology (ECNP) Congress being held in Amsterdam, The Netherlands.
Click and Boehringer Ingelheim have worked together since 2020, when they first announced a worldwide collaboration around a potential therapy for schizophrenia. In late 2022, the companies announced an expansion of the partnership, agreeing to collaborate on a second schizophrenia therapy.
Click Therapeutics has received marketing authorization for several other prescription digital products.Earlier this year, Click received marketing authorization and has launched Rejoyn (formerly CT-152), used as an adjunct to the use of antidepressants, for patients with major depressive disorder. Rejoyn, available by prescription, is a six-week treatment program designed to help enhance cognitive control of emotion through cognitive emotional training exercises for the brain and brief therapeutic lessons. Rejoyn costs $200 for the full six weeks.
The company has also received marketing authorization for CT-132, the first digital therapeutic for the preventive treatment of episodic migraine in the United States, alongsideacute and/or other preventive treatments. The company has received marketing authorization for AspyreRx, which aims to aid behavioral change in patients with Type 2 diabetes. However, both these products have not yet launched.