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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 12 (day 84)
Awards & highlights
Summary
This trial tests a medication called RO6889450 to see if it can help people with schizophrenia and schizoaffective disorder by reducing negative symptoms like lack of motivation and social withdrawal.
Eligible Conditions
- Schizophrenia, Schizoaffective Disorder
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to week 12 (day 84)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 12 (day 84)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Brief Negative Symptoms Scale (BNSS) Avolition/Apathy Subscore and Total Score at Baseline and Week 12
Secondary study objectives
Brief Negative Symptom Scale (BNSS) Total Scores
CGI-I Negative Symptoms Scores
CGI-S Negative Symptoms (NS) Scores
+7 moreSide effects data
From 2022 Phase 2 trial • 287 Patients • NCT045120666%
Headache
5%
Insomnia
5%
Anxiety
3%
Schizophrenia
3%
Weight increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
RO6889450 45 mg (Double-blind Treatment Period)
RO6889450 150 mg (Double-blind Treatment Period)
RO6889450 45 mg (Extension Period)
Risperidone 4 mg (Extension Period)
Placebo
Risperidone 4 mg (Double-blind Treatment Period)
Placebo - RO6889450 45 mg
Placebo - RO6889450 150 mg
RO6889450 150 mg (Extension Period)
Trial Design
2Treatment groups
Experimental Treatment
Group I: Part B: Add-On TherapyExperimental Treatment2 Interventions
Participants will receive a low or high dose of RO6889450 or a dose-matched placebo in addition to their usual anti-psychotic treatment(s).
Group II: Part A: MonotherapyExperimental Treatment2 Interventions
Participants will receive RO6889450 or a dose-matched placebo. NOTE: Part A has completed enrollment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RO6889450
2016
Completed Phase 2
~460
Placebo
1995
Completed Phase 3
~2670
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Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,447 Previous Clinical Trials
1,094,843 Total Patients Enrolled
18 Trials studying Schizophrenia
7,904 Patients Enrolled for Schizophrenia
Clinical TrialsStudy DirectorHoffmann-La Roche
2,217 Previous Clinical Trials
894,724 Total Patients Enrolled
17 Trials studying Schizophrenia
8,323 Patients Enrolled for Schizophrenia
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