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A Study to Assess the Effects of RO6889450 (Ralmitaront) in Participants With Schizophrenia or Schizoaffective Disorder and Negative Symptoms

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 up to week 12 (day 84)

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
  • Psychosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 12 (day 84)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 12 (day 84) for reporting.

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 more

Side effects data

From 2022 Phase 2 trial • 287 Patients • NCT04512066
5%
Headache
5%
Schizophrenia
2%
Insomnia
2%
Vomiting
2%
Nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
RO6889450 45 mg (Extension Period)
Risperidone 4 mg (Extension Period)
RO6889450 150 mg (Double-blind Treatment Period)
RO6889450 45 mg (Double-blind Treatment 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
Placebo
1995
Completed Phase 3
~2670
RO6889450
2016
Completed Phase 2
~460

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,459 Previous Clinical Trials
1,096,913 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,228 Previous Clinical Trials
895,859 Total Patients Enrolled
~19 spots leftby Dec 2025
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