Overview
- Click Therapeutics received FDA 510(k) clearance for Motivista (CT-155), a prescription digital therapeutic for negative symptoms of schizophrenia in adults aged ≥18 years.
- Motivista is the first FDA-authorized treatment specifically indicated for negative symptoms of schizophrenia, including low motivation, anhedonia, and social withdrawal.
- In the Phase III CONVOKE study, Motivista demonstrated a 62% relative improvement in negative symptom severity versus digital control at 16 weeks.
The News
Click Therapeutics has received FDA 510(k) clearance for Motivista (CT-155), a smartphone-based prescription digital therapeutic indicated for treating negative symptoms of schizophrenia as an adjunct to clinician-managed outpatient care, including antipsychotic therapy. The treatment is intended for adults ≥18 years with clinically stable positive symptoms.
In the Phase III CONVOKE study, Motivista produced a 6.8-point improvement in CAINS-MAP scores at 16 weeks versus 4.2 points with digital control, representing a 62% relative improvement (Cohen’s D: -0.36; p=0.0003). No serious treatment-related adverse events were reported.
Industry Perspective
Negative symptoms such as avolition, anhedonia, and asociality affect many people with schizophrenia and often persist despite control of positive symptoms. With limited treatment options specifically targeting these symptoms, Motivista introduces a digital approach that combines evidence-based psychosocial interventions with smartphone-based delivery.
Strategic Impact
The FDA clearance establishes a new digital treatment category for negative symptoms of schizophrenia and expands Click Therapeutics’ role in prescription digital therapeutics. With commercial availability being prepared, the company’s focus will shift toward payer, provider, and patient-advocacy partnerships to support broader access to Motivista.
Source: Globenewswire
