Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-30 @ 4:07 AM
Study NCT ID:
NCT05438160
Status:
COMPLETED
Last Update Posted:
2025-07-17
First Post:
2022-05-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploratory Study of a Digital Therapeutics in People With Schizophrenia
Sponsor:
Click Therapeutics, Inc.
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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.
This 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.
Eligible participants must have a diagnosis of schizophrenia per Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5).
Participants 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.
This 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.
Eligible participants must have a diagnosis of schizophrenia per Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5).
Participants 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: