NCT06067984CompletedPhase 3
An Extension Study of a Second Course of a Digital Therapeutic for the Treatment of Experiential Negative Symptoms of Schizophrenia
A Single-Arm, Open Label, 16-week Extension Study to Evaluate the Efficacy and Safety of a Second Course of a Digital Therapeutic as an Adjunct to Standard of Care Antipsychotic Therapy in Adult and Late Adolescent Participants With Experiential Negative Symptoms of Schizophrenia
Source: ClinicalTrials.gov · Last updated 5 Jun 2026
Brief summary (registry, in English)
The purpose of the proposed an open label extension (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 NCT05838625.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 73 (actual)
- First submitted
- 28 Sept 2023
- Start date
- 12 Sept 2023
- Primary completion date
- 13 Jun 2025
- Lead sponsor
- Click Therapeutics, Inc.
- Diseases
- Schizophrenia
- NCT number
- NCT06067984
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 73
- From 12 Sept 2023 to the primary completion date, 13 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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:
- Participants with a "yes" response to either Items 4 or 5 on the C-SSRS Suicidal Ideation Item during the NCT05838625 study.
- 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
Other
- A participant will not be eligible for study entry if any of the following criteria are met:
- Has not completed the Week 16 Visit (Day 112) in the NCT05838625 study.
- Participants who, in the opinion of the investigator, present a serious risk of suicide.
Who the study is looking for
- A participant will be eligible for entry into the study if all the following criteria are met:
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Click Therapeutics Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.