An Extension Study of a Second Course of a Digital Therapeutic for the Treatment of Experiential Negative Symptoms of Schizophrenia
NCT ID: NCT06067984
Last Updated: 2025-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
73 participants
INTERVENTIONAL
2023-09-12
2025-08-22
Brief Summary
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Detailed Description
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The purpose of the proposed OLE study is to evaluate the maintained efficacy and safety of a second consecutive course of Click Therapeutics Study App as an adjunct treatment to standard of care (SOC) in participants who were on the Study App and have recently completed the Click Therapeutics Randomized Clinical Trial.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm A
Evaluate the efficacy and safety of a digital therapeutic as an adjunct treatment to SOC in participants with experiential negative symptoms of schizophrenia.
Study App
An investigational prescription digital therapeutic in the form of a smartphone app.
Interventions
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Study App
An investigational prescription digital therapeutic in the form of a smartphone app.
Eligibility Criteria
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Inclusion Criteria
* Completed participation in NCT05838625 study within 7 days of the extension study Baseline Visit (Day 1).
* Is the sole user of an iPhone with an iPhone operating system (iOS) 14 or greater or a smartphone with an Android operating system (OS) 10 or greater and is willing to download and use the specified Study App required by the protocol.
* Is willing and able to receive SMS text messages and push messages on their smartphone.
* It is the owner of, and has regular access to, an email address.
* Has regular access to the Internet via cellular data plan and/or wi-fi.
* Had stable housing during NCT05838625, with no anticipated housing changes during the duration of this study.
Exclusion Criteria
* Has not completed the Week 16 Visit (Day 112) in the NCT05838625 study.
* Has a positive urine drug screening or participant self-reports use of synthetic cathinones (bath salts), synthetic cannabinoids (K2, Spice), inhalants, amphetamines (including MDMA/ecstasy), phencyclidine (PCP), cocaine, opiates, benzodiazepines, barbiturates, hallucinogens, or parenteral drugs. Participants with a positive urine drug test and/or recreational use of THC will not be excluded from the study at the discretion of the investigator. Participants with a positive urine drug screen (UDS) or self-report who have a valid prescription for barbiturates, benzodiazepines, or opiates will not be excluded from the study at the discretion of the investigator.
* Has suicidal ideation or behavior, as assessed by the C-SSRS:
1. Participants with a "yes" response to either Items 4 or 5 on the C-SSRS Suicidal Ideation Item during the NCT05838625 study.
2. Participants with a "yes" response on the C-SSRS Suicidal Behavior Items within the last 6 months (26 weeks) prior to or at the Baseline Visit
* Participants who, in the opinion of the investigator, present a serious risk of suicide.
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Click Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Viveca Livezey, MD
Role: STUDY_DIRECTOR
Click Therapeutics
Locations
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Click Therapeutics
New York, New York, United States
Countries
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Other Identifiers
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CT-155-E-001
Identifier Type: -
Identifier Source: org_study_id
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