A Randomized, Multicenter, 16-week Study to Evaluate the Efficacy and Safety of Two Prescription Digital Therapeutics as an Adjunct to Standard-of-Care Antipsychotic Therapy in Adult and Late Adolescent Participants With Experiential Negative Symptoms of Schizophrenia

  • NCT05838625
  • PHASE3
  • INTERVENTIONAL

Last updated: 2024-05-13

Purpose of  Trial

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.


This study is for people with

Schizophrenia


Interventions being studied

Digital Therapeutic

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).

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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ELIGIBILITY

Gender: ALL

Age: 18+

Healthy Volunteers: No

Location
New York

Click Therapeutics


New York, 10013, United States
Primary Contact(s)

Boehringer Ingelheim

Data obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Learn more at ClinicalTrials.gov

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