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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Schizophrenia, Schizoaffective Disorder

In brief

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

Key facts

Study ID: NCT03669640
Run by: Hoffmann-La Roche
People needed: 131
Starts: 2018-12-04
Expected to finish: 2023-03-12
Last updated by the study team: 2024-08-12

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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
Positive result at screening for hepatitis B surface antigen (HBsAg), hepatitis C (HCV), or HIV-1 and HIV-2. HCV antibody positive participants are eligible if HCV RNA is negative
Tardive dyskinesia that is moderate to severe or requires treatment
History of neuroleptic malignant syndrome
Average triplicate Fridericia's Correction Formula (QTcF) interval greater than 450 milliseconds (msec) for males and 470 msec for females or other clinically significant abnormality on screening electrocardiogram (ECG) based on centralized reading
Clinically significant abnormalities in laboratory safety test results
Significant or unstable physical condition that in the investigator's judgment might require a change in medication or hospitalization during the course of the study
On more than one antidepressant, or if on one antidepressant, a change in dose within 28 days prior to screening
History of clozapine treatment
History of treatment with electroconvulsive therapy (ECT)
Concomitant use of prohibited medications
Positive urine drug screen for amphetamines, methamphetamines, opiates, buprenomorphine, methadone, cannabinoids, cocaine, and barbiturates
Receipt of an investigational drug within 28 days or five times the half-life of the investigational drug (whichever is longer) before the first study drug administration
Donation of blood over 400 mL within 3 months prior to screening
Diagnosis of COVID-19 infection (confirmed or presumptive) 4 weeks prior to screening or during screening. Participants can be re-screened after 4 weeks of full recovery in addition to Investigator and/or institutional approval to enroll

Where it is running

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
Innovative Clinical Research, Inc. — Lauderhill, Florida, United States
Lifestream Behavioral Center — Leesburg, Florida, United States
Advanced Research Institute of Miami — Miami, Florida, United States
Health Synergy Clinical Research — Okeechobee, Florida, United States
Emory University — Atlanta, Georgia, United States
Northwestern University — Chicago, Illinois, United States
CBH Health — Gaithersburg, Maryland, United States
Precise Research Centers — Flowood, Mississippi, United States
Psych Care Consultants Research — St Louis, Missouri, United States
Millennium Psychiatric Associates, LLC — St Louis, Missouri, United States
Manhattan Psychiatric Center; Psychopharmacology Research Unit — New York, New York, United States
JPS Health Network — Fort Worth, Texas, United States
Pillar Clinical Research LLC — Garland, Texas, United States
Baylor College of Medicine — Houston, Texas, United States
University Hills Clinical Research — Irving, Texas, United States

Full record on ClinicalTrials.gov

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