Back to resultsAn Extension Study of a Second Course of a Digital Therapeutic for the Treatment of Experiential Negative Symptoms of Schizophrenia
Primary Purpose
Schizophrenia, Negative Symptoms in Schizophrenia
Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Study App
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Prescription digital therapeutic (PDT), Software as a Medical Device (SaMD), Smartphone app, Schizophrenia, Negative Symptoms
Eligibility Criteria
Inclusion Criteria: A participant will be eligible for entry into the study if all the following criteria are met: Completed participation in NCT05853900 (Week 20) 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 NCT05853900, 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 NCT05853900 study. Has a positive urine drug screening at Baseline Visit for amphetamines (including MDMA/ecstasy), phencyclidine (PCP), cocaine, opiates, benzodiazepines, or barbiturates. Participants with a positive urine drug test and/or recreational use of THC may be recruited 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 NCT05853900 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 Participants who, in the opinion of the investigator, present a serious risk of suicide.
Sites / Locations
- Click TherapeuticsRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm A
Arm Description
Evaluate the efficacy and safety of a digital therapeutic as an adjunct treatment to SOC in participants with experiential negative symptoms of schizophrenia.
Outcomes
Primary Outcome Measures
Change in Experiential Negative Symptoms
Change from baseline to Week 16 in the Clinical Assessment Interview for Negative Symptoms, Motivation and Pleasure Scale (CAINS-MAP)
Secondary Outcome Measures
Change in Experiential Negative Symptoms
Change from baseline to Week 8 in the CAINS-MAP
Change in Expressive Negative Symptoms
Change from baseline to Week 8 and to Week 16 in expressive negative symptoms, as assessed by the CAINS-EXP
Change in Positive Symptoms
Change from baseline to Week 16 in positive symptoms, as assessed by the Positive and Negative Syndrome Scale (PANSS)
Change in Social Functioning
Change from baseline to Week 16 in social functioning, as assessed by the Personal and Social Performance Scale (PSP)
Change in Defeatist Beliefs
Change from baseline to Week 16 in self-reported defeatist beliefs, as assessed by the Defeatist Beliefs Subscale of the Dysfunctional Attitude Scale (DAS)
Impression of Improvement
Patient Global Impression of Improvement Scale (PGI-I) at Week 16
Full Information
NCT ID
NCT06067984
First Posted
September 28, 2023
Last Updated
September 28, 2023
Sponsor
Click Therapeutics, Inc.
Collaborators
Boehringer Ingelheim
1. Study Identification
Unique Protocol Identification Number
NCT06067984
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 12, 2023 (Actual)
Primary Completion Date
September 24, 2024 (Anticipated)
Study Completion Date
October 24, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Click Therapeutics, Inc.
Collaborators
Boehringer Ingelheim
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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 NCT05853900.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Negative Symptoms in Schizophrenia
Keywords
Prescription digital therapeutic (PDT), Software as a Medical Device (SaMD), Smartphone app, Schizophrenia, Negative Symptoms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
216 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm A
Arm Type
Experimental
Arm Description
Evaluate the efficacy and safety of a digital therapeutic as an adjunct treatment to SOC in participants with experiential negative symptoms of schizophrenia.
Intervention Type
Device
Intervention Name(s)
Study App
Intervention Description
An investigational prescription digital therapeutic in the form of a smartphone app.
Primary Outcome Measure Information:
Title
Change in Experiential Negative Symptoms
Description
Change from baseline to Week 16 in the Clinical Assessment Interview for Negative Symptoms, Motivation and Pleasure Scale (CAINS-MAP)
Time Frame
Baseline to Week 16
Secondary Outcome Measure Information:
Title
Change in Experiential Negative Symptoms
Description
Change from baseline to Week 8 in the CAINS-MAP
Time Frame
Baseline to Week 8
Title
Change in Expressive Negative Symptoms
Description
Change from baseline to Week 8 and to Week 16 in expressive negative symptoms, as assessed by the CAINS-EXP
Time Frame
Baseline to Weeks 8 and 16
Title
Change in Positive Symptoms
Description
Change from baseline to Week 16 in positive symptoms, as assessed by the Positive and Negative Syndrome Scale (PANSS)
Time Frame
Baseline to Week 16
Title
Change in Social Functioning
Description
Change from baseline to Week 16 in social functioning, as assessed by the Personal and Social Performance Scale (PSP)
Time Frame
Baseline to Week 16
Title
Change in Defeatist Beliefs
Description
Change from baseline to Week 16 in self-reported defeatist beliefs, as assessed by the Defeatist Beliefs Subscale of the Dysfunctional Attitude Scale (DAS)
Time Frame
Baseline to Week 16
Title
Impression of Improvement
Description
Patient Global Impression of Improvement Scale (PGI-I) at Week 16
Time Frame
Week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A participant will be eligible for entry into the study if all the following criteria are met:
Completed participation in NCT05853900 (Week 20) 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 NCT05853900, 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 NCT05853900 study.
Has a positive urine drug screening at Baseline Visit for amphetamines (including MDMA/ecstasy), phencyclidine (PCP), cocaine, opiates, benzodiazepines, or barbiturates. Participants with a positive urine drug test and/or recreational use of THC may be recruited 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 NCT05853900 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
Participants who, in the opinion of the investigator, present a serious risk of suicide.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Research Coordinator
Phone
877-352-5425
Email
researchcoordinator@clicktherapeutics.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaheen Lakhan, MD, PhD, FAAN
Organizational Affiliation
Click Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Click Therapeutics
City
New York
State/Province
New York
ZIP/Postal Code
10013
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
877-352-5425
12. IPD Sharing Statement
Learn more about this trial
An Extension Study of a Second Course of a Digital Therapeutic for the Treatment of Experiential Negative Symptoms of Schizophrenia
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