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

TERMINATEDPHASE2

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

Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Effects of RO6889450 (Ralmitaront) in Patients With Schizophrenia or Schizoaffective Disorder and Negative Symptoms

NCT03669640•Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

This study investigates the effects of RO6889450 on the negative symptoms associated with schizophrenia and schizoaffective disorder.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients with a Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnosis of schizophrenia or schizoaffective disorder as confirmed by the Mini International Neuropsychiatric Interview (MINI)
•Part B only: Stable treatment with a dopamine/serotonin (D2/5HT2A) antagonist or pure D2 antagonist(s), or a D2 partial agonist for a minimum of 6 months and receiving no more than two antipsychotics
•Medically stable during the 3 months prior to study entry
•Participant is an outpatient with no psychiatric hospitalizations within the prior 6 months
•PANSS negative symptom factor score of 18 or higher
•The following rating on items of the PANSS: (a) less than 5 on G8 (uncooperativeness), P1 (delusions), P3 (hallucinations), P4 (excitement/hyperactivity), and P6 (suspiciousness/persecution); (b) less than 4 on P7 (hostility), and G14 (poor impulse control)
•Has an informant who is considered reliable by the Investigator
•Body mass index (BMI) between 18-40 kg/m2 inclusive
•Female participants are eligible to participate if 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
•Tardive dyskinesia that is moderate to severe or requires treatment
+12 more criteria

Exclusion Criteria

•Moderate to severe substance use disorder within six months of study entry (excluding nicotine or caffeine) as defined by DSM-5
•Extrapyramidal symptom rating scale (ESRS-A CGI) subscore greater than or equal to 3
•Other current DSM-5 diagnosis (e.g., bipolar disorder, major depressive disorder)
•PANSS item G6 (depression) greater than or equal to 5
•Significant risk of suicide or harming him- or herself or others according to the Investigator's judgment
•A prior or current general medical condition that might be impairing cognition or other psychiatric functioning

Locations (45)

CITrials, Inc.

Bellflower, California, United States

Collaborative Neuroscience Network, Inc.

Garden Grove, California, United States

California Clinical Trials

Glendale, California, United States

Synergy San Diego

Lemon Grove, California, United States

Catalina Research Institute LLC - MRA

Montclair, California, United States

CITrials, Inc.

Riverside, California, United States

California Neuropsychopharmacology Clinical Research Institute, LLC

San Diego, California, United States

Stanford University School of Medicine

Stanford, California, United States

Collaborative Neuroscience Network Inc.

Torrance, California, United States

Yale School of Medicine - CT Mental Health Center (CMHC) - Schizophrenia Research Clinic

New Haven, Connecticut, United States

Key Dates

Start Date

December 4, 2018

Primary Completion Date

March 12, 2023

Completion Date

March 12, 2023

Last Updated

August 12, 2024

Enrollment

131

ACTUAL participants

Conditions

Schizophrenia, Schizoaffective Disorder

Interventions

RO6889450

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 12, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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