This Study Tests Whether BI 409306 Prevents Patients With a Specific Type of Mental Illness (Attenuated Psychosis Syndrome) From Becoming Worse. This Study Looks at How Well Patients Tolerate the Medicine and How Effective it is Over 1 Year
- Conditions
- Psychotic Disorders
- Interventions
- Drug: BI 409306Drug: Placebo
- Registration Number
- NCT03230097
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
This is a study in people between 16 and 30 years of age who have a specific type of mental illness called attenuated psychosis syndrome (APS). The purpose of this study is to find out whether BI 409306 helps reduce the symptoms of APS.
Participants are in the study for 1 year and 2 months. During this time, they visit the study site about 15 times and get about 10 phone calls. Participants are put into 2 groups by chance. They get either BI 409306 or placebo. Placebo tablets look like BI 409306 tablets but do not contain any medicine. Participants take a BI 409306 or placebo tablet two times a day.
During the study, participants answer questions in interviews and complete questionnaires so the doctors can check whether the APS symptoms change. The doctors also check the general health of the participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BI 409306 BI 409306 Patients meeting Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnostic criteria for attenuated psychosis syndrome (APS) per the Structured Interview for Psychosis-Risk Syndromes (SIPS) took 50 milligrams BI 409306, as a film-coated tablet, orally twice a day at approximately the same time every day in the morning and in the evening (approximately 12 hours apart) with or without food for 52 weeks. Placebo Placebo Patients meeting Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnostic criteria for attenuated psychosis syndrome (APS) per the Structured Interview for Psychosis-Risk Syndromes (SIPS) took placebo matching 50 milligrams BI 409306, as a film-coated tablet, orally twice a day at approximately the same time every day in the morning and in the evening (approximately 12 hours apart) with or without food for 52 weeks.
- Primary Outcome Measures
Name Time Method Incidence of Remission From Attenuated Psychosis Syndrome (APS) Within a 52-week Timeframe Up to 52 weeks. Incidence of remission from attenuated psychosis syndrome (APS) within a 52-week timeframe. The incidence rate per patient-years of remission from attenuated psychosis syndrome (APS) is reported. Remission from APS is defined as a score of \<3 on all of the five Positive Symptom items of the Scale of Prodromal Symptoms (SOPS) and maintained until the end of treatment. The SOPS provides a 6-point scale (minimum of 0 and maximum of 6, higher score indicating worse symptoms) to quantitatively rate the severity of five attenuated positive symptoms. incidence rate = number of events/total time at risk \[patient-years\].
- Secondary Outcome Measures
Name Time Method Incidence of First Episode of Psychosis Up to 52 weeks. Incidence of first episode of psychosis. The incidence rate per patient-years of psychosis is reported, psychosis is defined as one or more positive Scale of Prodromal Symptoms (SOPS) symptoms rated a 6 AND either a symptom is seriously disorganizing or dangerous OR one of the symptoms above occurred at least one hour per day at an average frequency of four days/week over the past month. OR a new prescription or increase in dose of an ongoing antipsychotic medication. The SOPS provides a 6-point scale (minimum of 0 and maximum of 6, higher score indicating worse symptoms) to quantitatively rate the severity of five attenuated positive symptoms.
Change From Baseline in Everyday Functional Capacity as Measured by Schizophrenia Cognition Rating Scale (SCoRS) Total Score After 24 and 52 Weeks of Treatment Baseline, week 24 and week 52. Change from baseline (Day -28 to -7) in everyday functional capacity as measured by Schizophrenia Cognition Rating Scale (SCoRS) total score after 24 and 52 weeks of treatment. 20-item assessment of cognitive deficits and the degree to which they affect day-to-day functions. Each of the 20 items of the SCoRS is rated on a 4-point scale (minimum of 1 and maximum of 4). Higher ratings reflect a greater degree of impairment. The composite score will be the sum of the 20 items (minimum of 20 and maximum of 80). Data analyzed using the restricted maximum likelihood (REML) mixed effects model with repeated measurements (MMRM) including fixed, categorical effects of treatment, visit, treatment by visit interaction, baseline North American Prodromal Longitudinal Study (NAPLS) risk score, baseline use of antipsychotic medication and continuous fixed covariates of baseline score and baseline-by-visit interaction.
Change From Baseline in the Tablet Based Brief Assessment of Cognition (BAC App) Composite T Score After 52 Weeks of Treatment Baseline and week 52. Change from baseline (Day -28 to -7) in the tablet based Brief Assessment of Cognition (BAC App) composite T score after 52 weeks of treatment. The BAC consists of five tests assessing multiple domains of cognitive function: Verbal Memory, Digit Sequencing, Semantic and Letter Fluency, Symbol Coding, and Tower of London. A composite T score that is calculated using the five standardized scaled sub-test scores was generated (averages five of the standardized scaled sub-test scores, token motor test score not included), larger T-score indicates better cognition. Data analyzed using the REML MMRM including fixed, categorical effects of treatment, visit, treatment by visit interaction, baseline North American Prodromal Longitudinal Study (NAPLS) risk score, baseline use of antipsychotic medication and continuous fixed covariates of baseline score and baseline-by-visit interaction. T-scores in the general population have a mean of 50 and standard deviation of 10.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Positive Items Score, Negative Items Score, and Total Score After 52 Weeks of Treatment Baseline and week 52. Change from baseline (Day -28 to -7) in Positive and Negative Syndrome Scale (PANSS) positive items score, negative items score, and total score after 52 weeks of treatment. The PANSS positive and negative symptom scales each have 7 items, and the General Psychopathology Scale (not reported) has 16 items. The patient is rated from 1 to 7 on the 30 different items based on the interview, as well as reports from an informant when possible. Total score is the sum of the score of the 30 items (minimum 30, maximum 210), subtotal are the sum of either the positive or negative scales (minimum 7, maximum 49), lower scores represent an improvement in schizophrenia symptoms. Data analyzed using the REML MMRM including fixed, categorical effects of treatment, visit, treatment by visit interaction, baseline NAPLS risk score, baseline use of antipsychotic medication and continuous fixed covariates of baseline score and baseline-by-visit interaction.
Trial Locations
- Locations (33)
Michigan Clinical Research Institute PC
🇺🇸Ann Arbor, Michigan, United States
Precise Research Centers
🇺🇸Flowood, Mississippi, United States
PRIME Clinic
🇺🇸New Haven, Connecticut, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
University of Florida College of Medicine
🇺🇸Jacksonville, Florida, United States
Medical Research Group of Central Florida
🇺🇸Orange City, Florida, United States
Psychiatric and Behavioral Solutions, LLC
🇺🇸Salt Lake City, Utah, United States
Cherry Health
🇺🇸Grand Rapids, Michigan, United States
University of Calgary
🇨🇦Calgary, Alberta, Canada
Chatham-Kent Clinical Trials Research Centre
🇨🇦Chatham, Ontario, Canada
Augusta University
🇺🇸Augusta, Georgia, United States
Alan D. Lowe Medicine Professional Corporation
🇨🇦Toronto, Ontario, Canada
ProScience Research Group
🇺🇸Culver City, California, United States
University of California San Diego
🇺🇸San Diego, California, United States
Center For Emotional Fitness
🇺🇸Cherry Hill, New Jersey, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
Finger Lakes Clinical Research
🇺🇸Rochester, New York, United States
University of Michigan Health System
🇺🇸Ann Arbor, Michigan, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
King's College Hospital
🇬🇧London, United Kingdom
PeaceHealth Medical Group
🇺🇸Eugene, Oregon, United States
New York State Psychiatric Institute
🇺🇸New York, New York, United States
Shanghai Mental Health Center
🇨🇳Shanghai, China
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Altea Research Institute
🇺🇸Las Vegas, Nevada, United States
University Hills Clinical Research
🇺🇸Irving, Texas, United States
The University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
University of Alberta Hospital (University of Alberta)
🇨🇦Edmonton, Alberta, Canada
Community Clinical Research, Inc.
🇺🇸Austin, Texas, United States
Holywell Hospital
🇬🇧Antrim, United Kingdom
Peking University Sixth Hospital
🇨🇳Beijing, China
University of Manchester
🇬🇧Manchester, United Kingdom
The Barberry National Centre for Mental Health
🇬🇧Birmingham, United Kingdom