Phase
Condition
Mood Disorders
Psychosis
Tourette's Syndrome
Treatment
Digital therapeutic (CT-155)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria
Has a primary diagnosis of schizophrenia using the diagnostic criteria for schizophrenia as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5 TR), and/or International Classification of Disease-10 (ICD-10) diagnosis code consistent with a schizophrenia diagnosis.
Has a Clinical Global Impression - Schizophrenia (CGI-SCH) negative symptoms score (item #2) ≥ 4 (moderately ill) at Screening.
18 years of age or older at the time of informed consent.
Is willing and able to use CT-155 in English language regularly, to provide written informed consent to participate in the study and to be compliant with study-related assessments and activities.
Has outpatient treatment status at the time of screening, with no inpatient treatment for schizophrenia within 12 weeks prior to Screening.
Is on an antipsychotic medication(s) for at least 12 weeks prior to study entry.
Is the sole user of an iPhone with an iPhone operating system (iOS) 16+ or a smartphone with an Android operating system (OS) 12+ with a United States telephone number, and is willing to download and use the specified digital mobile application required by the protocol.
Is willing and able to receive SMS text messages and push notifications on their smartphone.
Further inclusion criteria apply.
Exclusion Criteria
Has a score of ≥3 (mildly ill) for CGI-SCH positive symptoms (item #1) at Screening.
Has active substance use disorder of any severity in the last 3 months, other than caffeine and nicotine. Patients are excluded if they fulfill criteria for moderate or severe substance use disorder for cannabis. Only mild substance use disorder for cannabis is allowed if considered by investigator to not impact ability of the patient to participate in the study.
Has suicidal ideation or behavior, as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS):
Patients with a "yes" response to either Items #4 or #5 on the C-SSRS Suicidal Ideation Item within the last 3 months (12 weeks) prior to screening, or at Screening.
Patients with a "yes" response on the C-SSRS Suicidal Behavior Items within the last 6 months (26 weeks) prior to screening or at Screening.
Patients who, in the opinion of the investigator, present a risk of suicide.
Is currently enrolled or has participated in the last 3 months (12 weeks) in a mental health related clinical study (interventional or observational).
Has participated in previous studies of CT-155 or CT-156.
Study Design
Connect with a study center
ATP Clinical Research
Costa Mesa, California 92626
United StatesSite Not Available
Sun Valley Behavioral Med Center
Imperial, California 92251
United StatesActive - Recruiting
University of California San Diego
La Jolla, California 92093
United StatesSite Not Available
North Country Clinical Research Inc
Oceanside, California 92054
United StatesActive - Recruiting
North County Clinical Research
Oceanside, California 92054
United StatesActive - Recruiting
ATP Clinical Research, Inc.
Orange, California 92866
United StatesActive - Recruiting
NRC Research
Orange, California 92868
United StatesActive - Recruiting
NRC Research Institute
Orange, California 92868
United StatesActive - Recruiting
Stanford University Medical Center
Stanford, California 94304
United StatesActive - Recruiting
Stanford University School of Medicine
Stanford, California 94304
United StatesActive - Recruiting
Cenexel
Torrance, California 90504
United StatesActive - Recruiting
Collaborative Neuroscience Research
Torrance, California 90504
United StatesActive - Recruiting
CT Clinical Research
Cromwell, Connecticut 06416
United StatesActive - Recruiting
Institute of Living
Hartford, Connecticut 06106
United StatesSite Not Available
Galiz Research
Hialeah, Florida 33106
United StatesActive - Recruiting
New Life Medical Research Center, Inc
Hialeah, Florida 33012
United StatesActive - Recruiting
New Life Medical Research Center, Inc.
Hialeah, Florida 88012
United StatesActive - Recruiting
Global Life Research
Miami, Florida 33155
United StatesActive - Recruiting
Global Life Research Network
Miami, Florida 33155
United StatesActive - Recruiting
University of Miami
Miami, Florida 33136
United StatesSite Not Available
Interventional Psychiatry of Tampa Bay
Tampa, Florida 33629
United StatesActive - Recruiting
Health Synergy Clinical Research, LLC
West Palm Beach, Florida 33407
United StatesActive - Recruiting
Emory University
Atlanta, Georgia 30303
United StatesSite Not Available
Emory University School of Medicine
Atlanta, Georgia 30303
United StatesSite Not Available
Pratt Shephard
Baltimore, Maryland 21204
United StatesActive - Recruiting
Sheppard Pratt Physicians's Practice Association, Inc.
Baltimore, Maryland 21204
United StatesActive - Recruiting
CenExel Center for Behavioral Health
Gaithersburg, Maryland 20877
United StatesActive - Recruiting
Center for Behavioral Health, LLC
Gaithersburg, Maryland 20877
United StatesActive - Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02115
United StatesSite Not Available
Boston Neurobehavioral Associates
Brookline, Massachusetts 02446
United StatesActive - Recruiting
University of Massachusetts - Worcester
Worcester, Massachusetts 01655
United StatesSite Not Available
Western Michigan University
Kalamazoo, Michigan 49048
United StatesActive - Recruiting
Midwest Research Group
Saint Charles, Missouri 63304
United StatesActive - Recruiting
St. Charles Psychiatric Associates & Midwest Research Group
Saint Charles, Missouri 63304
United StatesActive - Recruiting
Creighton University
Omaha, Nebraska 68124
United StatesActive - Recruiting
IMA Clinical Research - Las Vegas
Las Vegas, Nevada 89102
United StatesActive - Recruiting
IMA Clinical Research Las Vegas
Las Vegas, Nevada 89102
United StatesActive - Recruiting
Neurobehavioral Research
Cedarhurst, New York 11516
United StatesActive - Recruiting
Neurobehavioral Research, Inc.
Cedarhurst, New York 11516
United StatesActive - Recruiting
Columbia University
New York, New York 10032
United StatesSite Not Available
Richmond Behavioral Associates
Staten Island, New York 10314
United StatesActive - Recruiting
Richmond Behavioral Associates ERG Clinical Research - New York PLLC
Staten Island, New York 10314
United StatesActive - Recruiting
Atrium Health
Charlotte, North Carolina 28211
United StatesActive - Recruiting
Atrium Health Behavior Health Research
Charlotte, North Carolina 21211
United StatesActive - Recruiting
Oklahoma Clinical Research Center/Rivus Institute
Oklahoma City, Oklahoma 73112
United StatesActive - Recruiting
Rivus Wellness and Research Institute
Oklahoma City, Oklahoma 73112
United StatesActive - Recruiting
Axon Clinical Research
Philadelphia, Pennsylvania 19129
United StatesActive - Recruiting
Axon Psychiatry
Philadelphia, Pennsylvania 19129
United StatesActive - Recruiting
Psychiatric Consultants, PC
Franklin, Tennessee 37067
United StatesActive - Recruiting
Psychiatric Consultants,PC
Franklin, Tennessee 37067
United StatesActive - Recruiting
Beaumont Psychiatric Clinic
Beaumont, Texas 77706
United StatesActive - Recruiting
Beaumont Psychiatry Clinic
Beaumont, Texas 77706
United StatesActive - Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas 75390-8837
United StatesSite Not Available
Red Oak Psychiatry Associates, PA
Houston, Texas 77090
United StatesActive - Recruiting
SMS Clinical Research
Mesquite, Texas 75149
United StatesActive - Recruiting
Salem VA Medical Center
Salem, Virginia 24153
United StatesSite Not Available
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