An Exploratory, Double-arm, 8-week Study to Explore the Feasibility and Acceptability of Abbreviated Treatment with CT-156 in People with Schizophrenia.

A Multicenter, Exploratory, Randomized, Double-Arm, 8-week Study to Evaluate the Feasibility and Acceptability of an Abbreviated Treatment with CT-156 in People with Schizophrenia

An exploratory, double-arm, 8-week study to explore the feasibility and acceptability of abbreviated treatment with CT-156 for people with Schizophrenia.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Device: CT-156

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10013
      • Click Therapeutics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Willing and able to provide written informed consent to participate in the study, attend study visits, and comply with study-related requirements and assessments.
• Is at least 18 years of age at the time of informed consent.
• Fluent in written and spoken English, confirmed by ability to read and understand the informed consent form.
• Lives in the United States.
• Meets diagnostic criteria for a primary diagnosis of schizophrenia as defined in the ICD-11 or DSM-5 for at least 6 months prior to screening.
• Has outpatient treatment status at the time of screening, with no psychiatric inpatient hospitalization within 13 weeks (3 months) prior to screening.
• Is currently prescribed at least one typical and/or atypical antipsychotic medication and has been on the same antipsychotic medication(s) for at least 13 weeks (3 months) prior to enrollment (Day 1). Dose adjustments are permitted during the study as outlined in the respective package insert(s).
• Has an average domain score ≥2 in at least 2 domains of Understanding and Communicating, Getting Along with People, Life Activities - Household, or Participation in Society on the WHO-DAS 2.0.
• Participant is the only user of an iPhone with iPhone operating system (iOS) version 15 or later or a smartphone with an Android operating system (OS) version 12 or later and agrees to download and use the digital mobile application as required by the protocol.
• Is willing and able to receive short message service (SMS) text messages and push messages on their smartphone.
• Is the owner of or has regular access to an email address.
• Has regular access to the internet via cellular data plan and/or WiFi.
• Has stable housing and has remained at the same residence for at least 13 weeks (3 months) prior to screening and does not anticipate any housing changes for the duration of the study.
• Understands the use of Study App during the Screening Period and at the Baseline Visit, per investigator judgment.

Exclusion Criteria:

• Has positive symptoms of schizophrenia that, in the opinion of the investigator, would preclude effective engagement in the treatment to improve functional impairment.
• Is currently receiving or has received concomitant therapy, defined as individual or group-based structured treatment (e.g., Cognitive Behavioral Therapy, Social Skills Training, Motivational Interviewing, or Vocational/Occupational Therapy), within 3 months (13 weeks) prior to screening per investigator assessment.
• Is currently treated with more than 2 antipsychotic medications (including more than 2 dosage forms).
• Meets ICD-11 or DSM-5 criteria for diagnoses not under investigation that will impact compliance to the protocol, including schizophreniform, schizoaffective, or psychosis non-specific disorders (post-traumatic stress disorder [PTSD], bipolar disorder, major depressive disorder, developmental disorders).
• Meets ICD-11 or DSM-5 criteria for a current episode of depression, mania or hypomania.
• Meets ICD-11 or DSM-5 criteria for a current substance or alcohol use disorder (excluding caffeine and nicotine) that would interfere with compliance to the protocol, per investigator judgment. Diagnoses classified as in sustained remission are permitted.
• In the investigator's opinion, currently needs or will likely require prohibited concomitant medications and/or therapy during the study.

• Is at moderate to high risk for suicide, defined by any of the following:

  1. A "yes" response to either item 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation Items within the last 13 weeks (3 months) prior to screening or at Baseline (Day 1)
  2. A "yes" response on the C-SSRS Suicidal Behavior Items within the last 26 weeks (6 months) prior to screening or at Baseline (Day 1)
  3. In the opinion of the investigator, presents a serious risk of suicide
• Has participated in another clinical study (interventional or observational) in the last 13 weeks (3 months).
• Has previously participated in any of the following studies: CT-155-C-001, CT-155-C-002, CT-155-C-003, CT-155-P-00x, CT-155-A-001, CT-155-R- 001, CT-156-D-001, CT-156-C-001, CT-156-P-00x.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CT-156 + UXR; Study app investigational treatment for adult patients diagnosed with schizophrenia with up to five in-patient visits with three interviews for UXR (user experience research) arm.	Device: CT-156; CT-156 is a digital therapeutic (DTx) under development to treat patients 18 years of age and older with a diagnosis of schizophrenia under standard of care therapy who are on antipsychotic medication and not currently experiencing acute hallucinations or delusions.
Active Comparator: CT-156; Study App investigational treatment for adult patients diagnosed with Schizophrenia.	Device: CT-156; CT-156 is a digital therapeutic (DTx) under development to treat patients 18 years of age and older with a diagnosis of schizophrenia under standard of care therapy who are on antipsychotic medication and not currently experiencing acute hallucinations or delusions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Days Used	Number of days the Study App is opened out of total days of treatment	Day 0 to Week 8
Number of Times Study App is Opened	Number of times the Study App is opened during the treatment period	Day 0 to Week 8
Number of Medication Check-ins Completed	Number of medication check-ins completed during the treatment period out of total assigned	Day 0 to Week 8
Number of Assigned Tasks Completed	Number of assigned tasks completed during the treatment period	Day 0 to Week 8
Average Duration of Use	Average duration of each App-use session	Day 0 to Week 8

Collaborators and Investigators

• Sponsor: Click Therapeutics, Inc.
• Collaborators: Boehringer Ingelheim
• Investigators: Study Director: Shaheen Lakhan, Click Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2024
• Primary Completion (Actual): August 9, 2024
• Study Completion (Actual): August 9, 2024

Study Registration Dates

• First Submitted: June 27, 2024
• First Submitted That Met QC Criteria: July 2, 2024
• First Posted (Actual): July 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 8, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Schizophrenia; Smartphone app; Software as a Medical Device (SaMD)
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Schizophrenia
• Other Study ID Numbers: CT-156-C-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No