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RO6889450 for Schizophrenia

Phase 2
Waitlist Available
Research Sponsored by Hoffmann-La Roche
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 at pre-defined intervals from day 7 through the end of the follow-up period (approximately 16 weeks)
Awards & highlights

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at pre-defined intervals from day 7 through the end of the follow-up period (approximately 16 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at pre-defined intervals from day 7 through the end of the follow-up period (approximately 16 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Apathy
Secondary outcome measures
Area Under the Curve at Steady State (AUCss) of RO6889450
CGI-I Negative Symptoms Scores
Change from Baseline in Brief Negative Symptom Scale (BNSS) Symptom Factor Scores
+11 more

Side effects data

From 2022 Phase 2 trial • 287 Patients • NCT04512066
6%
Headache
5%
Insomnia
5%
Anxiety
3%
Schizophrenia
3%
Weight increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
RO6889450 45 mg (Double-blind Treatment Period)
RO6889450 150 mg (Double-blind Treatment Period)
Risperidone 4 mg (Double-blind Treatment Period)
Placebo - RO6889450 45 mg
Placebo - RO6889450 150 mg
RO6889450 45 mg (Extension Period)
RO6889450 150 mg (Extension Period)
Risperidone 4 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

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,434 Previous Clinical Trials
1,091,264 Total Patients Enrolled
18 Trials studying Schizophrenia
7,904 Patients Enrolled for Schizophrenia
Clinical TrialsStudy DirectorHoffmann-La Roche
2,202 Previous Clinical Trials
889,908 Total Patients Enrolled
17 Trials studying Schizophrenia
8,323 Patients Enrolled for Schizophrenia
~20 spots leftby Jun 2025
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