Study of Two Digital Therapeutics for the Treatment of Experiential Negative Symptoms of Schizophrenia

Phase 3

Recruiting

• Conditions: Schizophrenia
• Interventions: Device: Digital Therapeutic

• Registration Number: NCT05838625
• Lead Sponsor: Click Therapeutics, Inc.

Brief Summary

This study evaluates the efficacy of two prescription digital therapeutics (PDT) in addition to standard of care (SOC) therapy for the treatment of experiential negative symptoms of schizophrenia in late adolescents and adults.

Detailed Description

The purpose of the proposed study is to evaluate the efficacy and safety of two prescription digital therapeutics as an adjunct treatment to SOC in participants 18 years of age or older diagnosed with experiential negative symptoms of schizophrenia.

Study Timeline

• Study Start: 2023-03-31
• Study First Submitted: 2023-04-20
• Study First Submitted QC: 2023-04-20
• Study First Posted: 2023-05-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-17
• Last Update Posted: 2024-12-20
• Primary Completion: 2025-06-18
• Study Completion: 2025-07-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 432

Inclusion Criteria

A participant will be eligible for entry into the study if all of the following criteria are met:

1. Has a primary diagnosis of schizophrenia.
2. Is on a stable dose of antipsychotic medication(s).
3. Has obtained an average score of ≥2 (moderate to severe) in at least two of the three CAINS-MAP domains (Social, Work, or Recreational).

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Exclusion Criteria

A participant will not be eligible for study entry if any of the following criteria are met:

1. Is currently treated with more than two antipsychotic medications (including more than two dosage forms).
2. Meets DSM-5, for diagnoses not under investigation.
3. Has participated in a CT-155 clinical study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Digital Therapeutic B	Digital Therapeutic	Evaluate the efficacy and safety of digital therapeutic B as an adjunct treatment to SOC in participants with experiential negative symptoms of schizophrenia.
Digital Therapeutic A	Digital Therapeutic	Evaluate the efficacy and safety of digital therapeutic A as an adjunct treatment to SOC in participants with experiential negative symptoms of schizophrenia.

Primary Outcome Measures

Name	Time	Method
Experiential negative symptoms	Baseline to Week 16	Change from baseline to Week 16 in experiential negative symptoms, as assessed by Clinical Assessment Interview for Negative Symptoms, Motivation and Pleasure Scale (CAINS-MAP)

Secondary Outcome Measures

Name	Time	Method
Motivation and pleasure symptoms	Baseline to Week 8	Change from baseline in motivation and pleasure symptoms at Week 8, as assessed by CAINS-MAP
Expressive negative symptoms	Baseline to Weeks 8 and 16	Change from baseline in expressive negative symptoms at Weeks 8 and 16, as assessed by the Clinical Assessment Interview for Negative Symptoms, Expressivity Scale (CAINS-EXP)
Self-reported defeatist beliefs	Baseline to Weeks 8 and 16	Change from baseline in self-reported defeatist beliefs at Weeks 8 and 16, as assessed by the Defeatist Beliefs Subscale of the Dysfunctional Attitudes Scale (DAS)
Social functioning	Baseline to Weeks 8 and 16	Change from baseline in social functioning at Weeks 8 and 16, as assessed by the Personal and Social Performance Scale (PSP)
Positive symptoms	Baseline to Weeks 8 and 16	Change from baseline in positive symptoms at Weeks 8 and 16, as assessed by the Positive and Negative Syndrome Scale (PANSS)
Patient global impression of improvement	Weeks 8 and 16	Patient Global Impression of Improvement Scale (PGI-I) at Weeks 8 and 16

Trial Locations

Locations (2)

Investigational center; 🇺🇸 Salt Lake City, Utah, United States

Click Therapeutics; 🇺🇸 New York, New York, United States