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Click Therapeutics Receives 510(k) Clearance for Motivista to Treat Negative Schizophrenia Symptoms

Shots:

  • FDA granted 510(k) clearance to Motivista (CT-155), a prescription digital therapeutic for treating negative symptoms of schizophrenia as an adjunct to clinician-managed outpatient care, incl. antipsychotic therapy, in pts (≥18yrs.) with clinically stable positive symptoms
  • Clearance was supported by the P-III (CONVOKE) trial assessing CT-155 vs a digital control app in pts (≥18yrs.) with experiential negative symptoms of schizophrenia
  • Trial showed a 6.8 vs 4.2-point improvement in negative symptom severity on the CAINS-MAP at 16wks., representing a 62% relative improvement & achieving a Cohen’s D of -0.36; data were published in JAMA Network Open. Plus, 70.4% vs 76.5% pts also maintained strong adherence through Wk. 15

Ref: Globenewswire  |   Image: Click Therapeutics   |  Press Release

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