A Trial of the Efficacy and the Safety of RO6889450 (Ralmitaront) vs Placebo in Patients With an Acute Exacerbation of Schizophrenia or Schizoaffective Disorder
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Interventions
- Registration Number
- NCT04512066
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This study will investigate the efficacy and safety of RO6889450 as monotherapy in participants experiencing an acute exacerbation of symptoms of schizophrenia or schizoaffective disorder.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 287
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 4 mg QD Risperidone Risperidone Participants will receive 4 mg of risperidone QD for 4 weeks or 12 weeks or 48 weeks. 45 mg QD RO6889450 RO6889450 Participants will receive 45 mg of RO6889450 QD for 4 weeks or 12 weeks or 48 weeks. Placebo Placebo Participants will receive oral placebo QD for 4 weeks. Participants from this arm that continue to the extension period will be randomized to either 45 mg or 150 mg QD of RO6889450 for up to an additional 8 weeks or additional 44 weeks (optional 36-Week Safety Extension Phase). 150 mg Once Daily (QD) RO6889450 RO6889450 Participants will receive 150 mg of RO6889450 QD for 4 weeks or 12 weeks or 48 weeks.
- Primary Outcome Measures
Name Time Method Mean Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4 Week 4 (Day 28) The PANSS is a 30-item rating scale that evaluates positive, negative, and other symptoms in patients with schizophrenia. The Positive subscale is a 7-item scale that assesses features in schizophrenia that are not present in a normal mental state. The Negative subscale is a 7-item scale that assesses features absent in schizophrenia but present in those with a normal mental state. Items are rated on a 7-point scale, where 1 = absent and 7 = extreme, for a maximum score of 49 for each scale. The General subscale is a 16-item scale that assesses the overall severity of schizophrenia and the risk of aggression. Items are rated on the same scale, with a minimum score of 16 and a maximum score of 112. Total scores are calculated by adding subscale scores together, for a minimum score of 30 and a maximum score of 210. Higher scores indicate higher severity.
- Secondary Outcome Measures
Name Time Method CGI-S up to Week 12 Up to Week 12 The CGI-S measures global severity of illness at a given point in time using a 7-point scale, where 1 = no symptoms and 7 = very severe symptoms.
Participants Ready for Discharge From First Randomized Treatment Intake to Readiness for Discharge as Assessed by the Readiness for Discharge Questionnaire (RDQ) at 4-Week Treatment after 4-week treatment The RDQ is a tool used to assess inpatients with schizophrenia on their readiness for discharge from inpatient treatment. It consists of five items that assess suicidality/homicidality, control of aggression/impulsivity, activities of daily living, medication-taking, and delusions/hallucinations interfering with functioning and global status. An additional item examines the overall clinical state of the patient and the final question assesses readiness for discharge. The values reported are the proportion (expressed as a percentage) of participants in each analysis group considered ready for discharge according to the RDQ.
Proportion of Participants With at Least 20% or 50% Improvement in the PANSS Total Score up to Week 12 Weeks 4, 8, and 12 The PANSS is a 30-item rating scale that evaluates positive, negative, and other symptoms in patients with schizophrenia. The Positive subscale is a 7-item scale that assesses features in schizophrenia that are not present in a normal mental state. The Negative subscale is a 7-item scale that assesses features absent in schizophrenia but present in those with a normal mental state. Items are rated on a 7-point scale, where 1 = absent and 7 = extreme, for a maximum score of 49 for each scale. The General subscale is a 16-item scale that assesses the overall severity of schizophrenia and the risk of aggression. Items are rated on the same scale, with a minimum score of 16 and a maximum score of 112. Total scores are calculated by adding subscale scores together, for a minimum score of 30 and a maximum score of 210. Higher scores indicate higher severity.
Change From Baseline in PANSS Factor Scores at Week 4 Week 4 (Day 28) PANSS factors are modified groupings of the 30 PANSS items from the original three subscales (positive, negative, and general psychopathology). Each item is rated on a scale of 1 (absent) to 7 (most extreme). The positive symptom factor contains 8 items (score range 8-56); the negative symptom and disorganized thought/cognition factors contain 7 items (score range 7-49); the uncontrolled hostility/excitement, expressive deficit, and anxiety/depression factors contain 4 items (score range 4-28); and the avolition domain contains 3 items (score range 3-21). The negative and positive totals each have a range of 7-49 and the general total has a range of 16-112. Higher scores indicate higher symptom severity.
Plasma Concentration of RO6889450 Day 7 - Day 336 Proportion of Participants With at Least 20% or 50% Improvement From Baseline in the PANSS Total Score Baseline to Week 12 The PANSS is a 30-item rating scale that evaluates positive, negative, and other symptoms in patients with schizophrenia. The Positive subscale is a 7-item scale that assesses features in schizophrenia that are not present in a normal mental state. The Negative subscale is a 7-item scale that assesses features absent in schizophrenia but present in those with a normal mental state. Items are rated on a 7-point scale, where 1 = absent and 7 = extreme, for a maximum score of 49 for each scale. The General subscale is a 16-item scale that assesses the overall severity of schizophrenia and the risk of aggression. Items are rated on the same scale, with a minimum score of 16 and a maximum score of 112. Total scores are calculated by adding subscale scores together, for a minimum score of 30 and a maximum score of 210. Higher scores indicate higher severity.
Change From Baseline in Clinical Global Impression Severity (CGI-S) Scores Week 4 (Day 28) The CGI-S measures global severity of illness at a given point in time using a 7-point scale, where 1 = no symptoms and 7 = very severe symptoms.
Clinical Global Impression - Improvement (CGI-I) Scores Week 4 (Day 28) The CGI-I measures change from the baseline state at subsequent visits using a 7-point scale, where 1 = very much improved and 7 = very much worse.
PANSS Total Score at Week 12 Week 12 The PANSS is a 30-item rating scale that evaluates positive, negative, and other symptoms in patients with schizophrenia. The Positive subscale is a 7-item scale that assesses features in schizophrenia that are not present in a normal mental state. The Negative subscale is a 7-item scale that assesses features absent in schizophrenia but present in those with a normal mental state. Items are rated on a 7-point scale, where 1 = absent and 7 = extreme, for a maximum score of 49 for each scale. The General subscale is a 16-item scale that assesses the overall severity of schizophrenia and the risk of aggression. Items are rated on the same scale, with a minimum score of 16 and a maximum score of 112. Total scores are calculated by adding subscale scores together, for a minimum score of 30 and a maximum score of 210. Higher scores indicate higher severity.
CGI-I up to Week 12 Up to Week 12 The CGI-I measures change from the baseline state at subsequent visits using a 7-point scale, where 1 = very much improved and 7 = very much worse.
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Trial Locations
- Locations (39)
CNRI - Los Angeles, LLC
🇺🇸Pico Rivera, California, United States
Neuro-Behavioral Clinical Research, Inc.
🇺🇸Canton, Ohio, United States
Uptown Research Institute
🇺🇸Chicago, Illinois, United States
CITrials, Inc.
🇺🇸Riverside, California, United States
Galiz Research, LLC
🇺🇸Hialeah, Florida, United States
CBH Health LLC
🇺🇸Gaithersburg, Maryland, United States
Kyiv Medical Regional Union Psychiatry
🇺🇦Kylv, KIEV Governorate, Ukraine
Leningradskiy Regional Psychoneurologic Dispensary
🇷🇺St-Petersburg, Sankt Petersburg, Russian Federation
National Center of Neurology and Psychiatry
🇯🇵Tokyo, Japan
Collaborative Neuroscience Network, Inc.
🇺🇸Garden Grove, California, United States
Synergy San Diego
🇺🇸Lemon Grove, California, United States
Psychiatric Hospital St Nicholas the Wonderworker
🇷🇺St. Petersburg, Sankt Petersburg, Russian Federation
Seishinkai Okehazama Hospital Fujita Kokoro Care Center
🇯🇵Toyoake, Japan
Research Centers of America - ERG
🇺🇸Oakland Park, Florida, United States
Saratov regional clinical psychoneurological hospital St Sofii
🇷🇺Saratov, Russian Federation
Communal NPE Vinnytsia Reg. Clin. Psychoneurolog. Hosp. n.a. O.I. Yushchenko of Vinnytsia RC
🇺🇦Vinnytsia, Podolia Governorate, Ukraine
Poltava Regional Psychiatry Hospital
🇺🇦Poltava, Poltava Governorate, Ukraine
Atlanta Center For Medical Research
🇺🇸Atlanta, Georgia, United States
City Psychiatry Hospital #3 n.a. I.I. Skvortsov-Stepanov
🇷🇺St. Petersburg, Sankt Petersburg, Russian Federation
ProScience Research Group
🇺🇸Culver City, California, United States
Innovative Clinical Research, Inc.
🇺🇸Lauderhill, Florida, United States
Psychiatry Hospital #1 n.a. P.P.Kashchenko
🇷🇺St. Petersburg, Sankt Petersburg, Russian Federation
Pillar Clinical Research LLC
🇺🇸Garland, Texas, United States
Midwest Clinical Research Center - ERG - PPDS
🇺🇸Dayton, Ohio, United States
Public NPE Kherson Regional Institution of Mental Care of Kherson RC
🇺🇦Kherson, Kherson Governorate, Ukraine
Stavropol Regional Psychiatry Hospital #2
🇷🇺Stavropol, Russian Federation
Tomsk National Scientific Medical Center of Russian Academy of Sciences
🇷🇺Tomsk, Russian Federation
Woodland International Research Group Inc.
🇺🇸Little Rock, Arkansas, United States
California Clinical Trials Medical Group managed by Parexel
🇺🇸Glendale, California, United States
California Neuropsychopharmacology Clinical Research Institute, LLC
🇺🇸San Diego, California, United States
NRC Research Institute
🇺🇸Orange, California, United States
ASCLEPES Research Centers
🇺🇸Panorama City, California, United States
Schuster Medical Research Institute
🇺🇸Sherman Oaks, California, United States
Premier Clinical Research Institute - Miami - BTC - PPDS
🇺🇸Miami, Florida, United States
Artemis Institute For Clinical Research LLC - San Diego - ClinEdge - PPDS
🇺🇸San Diego, California, United States
FSBI National Medical Research Centre of Psychiatry and Neurology n.a. V.M. Bekhterev of MoH of RF
🇷🇺Sankt-peterburg, Vladimir, Russian Federation
Communal Non-Commercial Enterprise of Kharkiv RC Regional clinical psychiatric hospital #3
🇺🇦Kharkiv, Kharkiv Governorate, Ukraine
Communal Non-Commercial Enterprise Cherkasy Regional Psychiatric Hospital of Cherkasy RC
🇺🇦Smila, KIEV Governorate, Ukraine
Community Clinical Research Inc.
🇺🇸Austin, Texas, United States