Clinical trial NCT06067984: An Extension Study of a Second Course of a Digital Therapeutic for the Treatment of Experiential Negative Symptoms of Schizophrenia
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Schizophrenia
Negative Symptoms in Schizophrenia
Keywords: Prescription digital therapeutic (PDT)
Software as a Medical Device (SaMD)
Smartphone app
Schizophrenia
Negative Symptoms
Lead sponsor: Click Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Boehringer Ingelheim
First posted: 2023-10-05
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study evaluates the efficacy of a prescription digital therapeutic (PDT) in addition to standard of care (SOC) therapy for the treatment of experiential negative symptoms of schizophrenia in late adolescents and adults.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Click Therapeutics Study App is an interactive, software-based intervention for experiential negative symptoms of schizophrenia.

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.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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.
* 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.

Primary outcomes:
measure: Change in Experiential Negative Symptoms
timeFrame: Baseline to Week 16
Secondary outcomes:
measure: Change in Experiential Negative Symptoms
timeFrame: Baseline to Week 8
measure: Change in Expressive Negative Symptoms
timeFrame: Baseline to Weeks 8 and 16
measure: Change in Positive Symptoms
timeFrame: Baseline to Week 16
measure: Change in Social Functioning
timeFrame: Baseline to Week 16
measure: Change in Defeatist Beliefs
timeFrame: Baseline to Week 16
measure: Impression of Improvement
timeFrame: Week 16
Other outcomes:
Locations:
city: New York
country: United States
facility: Click Therapeutics
state: New York
Study officials:
affiliation: Click Therapeutics
name: Shaheen Lakhan, MD, PhD, FAAN
role: STUDY_DIRECTOR
References: