Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-31 @ 12:38 PM
Study NCT ID:
NCT05438160
Status:
COMPLETED
Last Update Posted:
2025-07-17
First Post:
2022-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploratory Study of a Digital Therapeutics in People With Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2022-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-14', 'studyFirstSubmitDate': '2022-05-18', 'studyFirstSubmitQcDate': '2022-06-24', 'lastUpdatePostDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To explore feasibility and acceptability of the medication tracking and educational components of a clinical learning study version of the CT-155 app', 'timeFrame': 'Day 49 at the end of treatment period', 'description': 'Degree of participant engagement with the study app as measured by participant app use data captured in-app'}], 'secondaryOutcomes': [{'measure': 'Change from Week 3 of the Mobile Agnew Relationships Measure', 'timeFrame': 'Change from Week 3 to Week 7 of the Mobile Agnew Relationships Measure', 'description': 'To explore the establishment of a digital working alliance over the course of the Study as assessed by the change from Week 3 to Week 7 of the Mobile Agnew Relationships Measure.\n\nThe Mobile Agnew Relationships Measures is on a 7-item scale that ranges from "Strongly Disagree" as scale 1 to "Strongly Agree" as scale 7.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Prescription digital therapeutics', 'Smartphone app', 'Schizophrenia'], 'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': 'CT-155 is a novel prescription digital therapeutic (PDT) being developed by Click Therapeutics, Inc. (Click) and Boehringer Ingelheim (BI) using an interactive, software-based intervention to treat schizophrenia', 'detailedDescription': 'CT-155 is a novel prescription digital therapeutic (PDT) being developed by Click Therapeutics, Inc. (Click) and Boehringer Ingelheim (BI). CT-155 delivers an interactive, software-based intervention for schizophrenia.\n\nThis is a multi-center, exploratory, single-arm study to evaluate the feasibility and acceptability of medication tracking and educational component of a clinical learning study version of CT-155 in adults diagnosed with schizophrenia.\n\nEligible participants must have a diagnosis of schizophrenia per Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5).\n\nParticipants that meet eligibility criteria will be enrolled in the study on Day 1. The study consists of an up to 7-day screening period, a 49-day engagement period, and an up to 7-day follow-up period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Is willing and able to provide written informed consent to participate in the study, attend study visits, and comply with study-related requirements and assessments.\n* 2\\. Between 18 and 64 years of age at time of informed consent.\n* 3\\. Fluent in written and spoken English, confirmed by ability to read and understand the informed consent form.\n* 4\\. Has a primary diagnosis of schizophrenia using the diagnostic criteria for schizophrenia as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5), for at least 1-year prior to screening.\n* 5\\. Is in the stable phase of illness, as assessed by the investigator after review of medical records or documented discussion with the treating physician.\n* 6\\. Has outpatient treatment status at the time of screening, with no inpatient treatment for schizophrenia within 12 weeks prior to screening.\n* 7\\. Is on a stable dose of antipsychotic medication(s) for at least 12 weeks prior to enrollment (Day 1) as determined by the investigator.\n* 8\\. Has obtained a score of 30 or less on the MAP-SR as assessed at the screening visit.\n* 9\\. Is the sole user, per participant self-report, of an iPhone with an iPhone operating system (iOS) 13 or greater or a smartphone with an Android operating system 9 or greater and is willing to download and use the Study App as required per the protocol.\n* 10\\. Is the owner of, and has regular access to, an email address.\n* 11\\. Has regular access to the internet via cellular data plan and/or wifi.\n* 12\\. Has stable housing and has remained at the same residence for at least 12 weeks prior to screening, with no anticipated housing changes during the duration of the study.\n* 13\\. Understands how to use the Study App during the screening visit as assessed by the investigator during in-clinic Study App installation and activation activities.\n\nExclusion Criteria:\n\n* 1\\. Is currently treated with more than two antipsychotic medications (including more than two dosage forms).\n* 2\\. Is currently treated with clozapine or haloperidol.\n* 3\\. Has active prominent positive symptoms in the opinion of the investigator that would preclude effective engagement in treatment for negative symptoms.\n* 4\\. Is currently receiving or has received psychotherapy within 12 weeks prior to screening.\n* 5\\. Meets either the International Classification of Diseases, Tenth Revision (ICD-10) or DSM-5 criteria for diagnoses not under investigation, including schizophreniform, schizoaffective, or psychosis non-specific disorders.\n* 6\\. Has post-traumatic stress disorder (PTSD), bipolar disorder, major depressive disorder, developmental disorders, or any prominent disorder that would interfere with compliance to the protocol, per investigator judgment.\n* 7\\. Has substance or alcohol use disorder (excluding caffeine and nicotine), that would interfere with compliance to the protocol, per investigator judgment.\n* 8\\. Currently needs or will likely require prohibited concomitant medications and/or therapy during the study, as determined by the investigator.\n* 9\\. Is currently participating in another clinical study (interventional or observational) involving investigational drugs or devices.\n* 10\\. Prior participation in the CT-155-C-001 clinical study.\n* 11\\. Has suicidal ideation or behavior, as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS):\n\n 1. Participants with a "yes" response to either Items 4 or 5 on the C-SSRS Suicidal Ideation Item within the last 12 weeks prior to screening or at baseline visit.\n 2. Participants with a "yes" response on the C-SSRS Suicidal Behavior Items within the last 26 weeks prior to screening or at baseline visit.\n 3. Participants who, in the opinion of the investigator, present a serious risk of suicide.\n* 12\\. In the judgment of the investigator, any evidence of a clinically significant concomitant disease or any other clinical condition that would jeopardize the participant\'s safety while participating in the clinical study.'}, 'identificationModule': {'nctId': 'NCT05438160', 'briefTitle': 'Exploratory Study of a Digital Therapeutics in People With Schizophrenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Click Therapeutics, Inc.'}, 'officialTitle': 'A Multi-center, Exploratory, Single-Arm, 7-week Study to Evaluate the Feasibility and Acceptability of the Medication Tracking and Educational Components of a Clinical Learning Version of CT-155 in People With Schizophrenia', 'orgStudyIdInfo': {'id': 'CT-155-C-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Clinical Learning Study version of CT-155', 'description': 'Single arm acceptability and feasibility of medication tracking and educational components of a clinical learning study version of CT-155', 'interventionNames': ['Device: Clinical Learning Study smartphone app (i.e., the study app)']}], 'interventions': [{'name': 'Clinical Learning Study smartphone app (i.e., the study app)', 'type': 'DEVICE', 'description': 'The study app is designed to provide 7-weeks of the medication tracking and educational components in a clinical learning study version of CT-155. This design allows inferences to be made about the usability and acceptability of these components of CT-155. Eligible participants will be enrolled during an in-person clinic visit on Day 1. Participants will then be directed to access the study app and perform tasks each day for the 49-day engagement period.', 'armGroupLabels': ['Clinical Learning Study version of CT-155']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92805', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'CT-155 Center', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '90502', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'CT-155 Center', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '75062', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'CT-155 Center', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '32746', 'city': 'Lake Mary', 'state': 'Florida', 'country': 'United States', 'facility': 'CT-155 Center', 'geoPoint': {'lat': 28.75888, 'lon': -81.31784}}, {'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'CT-155 Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '75062', 'city': 'Irving', 'state': 'Texas', 'country': 'United States', 'facility': 'CT-155 Center', 'geoPoint': {'lat': 32.81402, 'lon': -96.94889}}, {'zip': '77407', 'city': 'Richmond', 'state': 'Texas', 'country': 'United States', 'facility': 'CT-155 Center', 'geoPoint': {'lat': 29.58218, 'lon': -95.76078}}], 'overallOfficials': [{'name': 'Shaheen Lakhan, MDPhD, FAAN', 'role': 'STUDY_CHAIR', 'affiliation': 'Click Therapeutics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Click Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}