Clinical Study

Site For Fleck Ct-155-R-001 Digital Therapeutic (App) Study

Posted Date: Feb 17, 2023

  • Investigator: David Fleck
  • Specialties:
  • Type of Study: Device

The purpose of the proposed study is to evaluate the efficacy and safety of CT-155 as an adjunct treatment to SOC relative to a comparator Digital Control in participants aged 18 years or older diagnosed with experiential negative symptoms of schizophrenia. If demonstrated to be effective, CT-155 may be considered a novel digital therapeutic option as an adjunct treatment for patients diagnosed with experiential negative symptoms of schizophrenia.

Criteria:

(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. (2) Adult Or Late Adolescent, 18 Years Of Age Or Older At The Time Of Informed Consent. (3) Fluent In Written And Spoken English, Confirmed By Ability To Read And Understand The Informed Consent Form. (4) Has A Primary Diagnosis Of Schizophrenia Using The Diagnostic Criteria For Schizophrenia, As Defined In The Dsm-5, For At Least 6 Months Prior To The Screening Visit. (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. (6) Has Outpatient Treatment Status At The Time Of Screening, With No Inpatient Treatment For Schizophrenia Within 12 Weeks Prior To Screening. (7) Is On A Stable Dose Of Antipsychotic Medication(S) For At Least 12 Weeks Prior To Randomization (Day 1), With Dose Adjustments Permitted During The Study (And The 12 Weeks Prior To Randomization), As Outlined Within The Respective Package Inserts Of Their Current Medication(S) As Determined By The Investigator. (8) Has Obtained An Average Score Of =2 (Moderate To Severe) In At Least Two Of The Three Cains-Map Domains (Social, Work, Or Recreational) At The Screening Visit And At Baseline (Day 1). (9) 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. (10) Is Willing And Able To Receive Sms Text Messages And Push Messages On Their Smartphone. (11) Is The Owner Of, And Has Regular Access To, An Email Address. (12) Has Regular Access To The Internet Via Cellular Data Plan And/Or Wi-Fi. (13) 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. (14) Understanding Of And Interest In The Use Of The Study App During The Screening Period And The Baseline Visit (Day 1).

Keywords:

Schizophrenia, Adults, App Study

For More Information:

Sydney Sweeney
513-558-3314
sweenes4@ucmail.uc.edu


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