Study Summary
This trial is testing a new medication for people with schizophrenia or schizoaffective disorder to see if it can improve negative symptoms.
Eligible Conditions
- Schizophrenia, Schizoaffective Disorder
Treatment Effectiveness
Study Objectives
1 Primary · 14 Secondary · Reporting Duration: At pre-defined intervals from Day 7 through the end of the follow-up period (approximately 16 weeks)
Week 16
Area Under the Curve at Steady State (AUCss) of RO6889450
Maximum Serum Concentration (Cmax) of RO6889450
Week 16
Change from Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Scores
Change from Baseline in Extrapyramidal Symptom Rating Scale, Abbreviated (ESRS-A)
Percentage of Participants with Adverse Events (AE)
Baseline to Week 12
Apathy
Baseline to week 12
Change from Baseline in Brief Negative Symptom Scale (BNSS) Symptom Factor Scores
Change from Baseline in Brief Negative Symptom Scale (BNSS) Total Scores
Change from Baseline in CGI-S Negative Symptoms Scores
Change from Baseline in Clinical Global Impression Severity (CGI-S) Overall Scores
Change from Baseline in Defeatist Performance Attitude Scale (DPAS) Scores
Change from Baseline in Positive and Negative Syndrome Scale (PANSS) Symptom Factor Scores
Change from Baseline in Positive and Negative Syndrome Scale (PANSS) Total Scores
Week 12
CGI-I Negative Symptoms Scores
Clinical Global Impression - Improvement (CGI-I) Overall Scores
Trial Safety
Trial Design
2 Treatment Groups
Part A: Monotherapy
1 of 2
Part B: Add-On Therapy
1 of 2
Experimental Treatment
247 Total Participants · 2 Treatment Groups
Primary Treatment: RO6889450 · Has Placebo Group · Phase 2
Part A: MonotherapyExperimental Group · 2 Interventions: RO6889450, Placebo · Intervention Types: Drug, Drug
Part B: Add-On TherapyExperimental Group · 2 Interventions: RO6889450, Placebo · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RO6889450
2016
Completed Phase 1
~170
Placebo
1995
Completed Phase 3
~2670
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at pre-defined intervals from day 7 through the end of the follow-up period (approximately 16 weeks)
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,361 Previous Clinical Trials
1,067,836 Total Patients Enrolled
1 Trials studying Schizophrenia, Schizoaffective Disorder
286 Patients Enrolled for Schizophrenia, Schizoaffective Disorder
Clinical TrialsStudy DirectorHoffmann-La Roche
2,148 Previous Clinical Trials
875,926 Total Patients Enrolled
1 Trials studying Schizophrenia, Schizoaffective Disorder
286 Patients Enrolled for Schizophrenia, Schizoaffective Disorder
Eligibility Criteria
Age 18 - 55 · All Participants · 8 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have a diagnosis of schizophrenia or schizoaffective disorder as confirmed by the Mini International Neuropsychiatric Interview (MINI).
You have a BMI between 18-40 kg/m2 inclusive.
You are female and not pregnant, not breastfeeding and agree to remain abstinent or use acceptable contraceptive methods during the treatment period and for at least 28 days after the last dose of study drug.
Who else is applying?
What state do they live in?
| California | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Stanford University School of Medicine | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
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Conditions
Cancer Related
Treatments