A Study to Assess the Effects of RO6889450 (Ralmitaront) in Participants With Schizophrenia or Schizoaffective Disorder and Negative Symptoms
NCT ID: NCT03669640
Last Updated: 2024-08-12
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
131 participants
INTERVENTIONAL
2018-12-04
2023-03-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Part A: Monotherapy
Participants will receive RO6889450 or a dose-matched placebo. NOTE: Part A has completed enrollment.
RO6889450
Participants will receive a once-daily, oral dose of RO6889450 for 12 weeks.
Placebo
Participants will receive a once-daily, oral dose of placebo matched to RO6889450 for 12 weeks.
Part B: Add-On Therapy
Participants will receive a low or high dose of RO6889450 or a dose-matched placebo in addition to their usual anti-psychotic treatment(s).
RO6889450
Participants will receive a once-daily, oral dose of RO6889450 for 12 weeks.
Placebo
Participants will receive a once-daily, oral dose of placebo matched to RO6889450 for 12 weeks.
Interventions
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RO6889450
Participants will receive a once-daily, oral dose of RO6889450 for 12 weeks.
Placebo
Participants will receive a once-daily, oral dose of placebo matched to RO6889450 for 12 weeks.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
55 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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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
The Solace Center
Missouri City, Texas, United States
Psychiatry & Behavioral Center
Richmond, Texas, United States
@ Health Texas
Richmond, Texas, United States
Kohnodai Hp., National Center for Global Health and Medicine
Chiba, , Japan
National Hospital Organization Ryukyu Hospital
Kunigami, , Japan
National Center of Neurology and Psychiatry
Tokyo, , Japan
Seishinkai Okehazama Hospital Fujita Kokoro Care Center
Toyoake, , Japan
Hiyoshi Hospital
Yokohama, , Japan
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain
C.H. Regional Reina Sofia - PPDS
Córdoba, , Spain
Hosp Univ Fundacion Alcorcon
Madrid, , Spain
Complejo Asistencial Universitario de Salamanca ? H. Clinico
Salamanca, , Spain
CNCE Regional Clinical Psychiatric Hospital of Kirovohrad Regional Council
Nove, Katerynoslav Governorate, Ukraine
Communal Non-Commercial Enterprise of Kharkiv RC Regional clinical psychiatric hospital #3
Kharkiv, Kharkiv Governorate, Ukraine
Public NPE Kherson Regional Institution of Mental Care of Kherson RC
Kherson, Kherson Governorate, Ukraine
Municipal Non-Commercial Enterprise Odesa RMC for Mental Health of Odessa Regional Council
Odesa, Kherson Governorate, Ukraine
ME Dnipropetrovsk Regional Clinical Hospital n.a. I.I Mechnykov Dnipropetrovsk Regional Council
Dnipro, KIEV Governorate, Ukraine
Zakarpattia Regional Clinical Hospital n.a. Andrii Novak
Uzhhorod, KIEV Governorate, Ukraine
Communal NPE Vinnytsia Reg. Clin. Psychoneurolog. Hosp. n.a. O.I. Yushchenko of Vinnytsia RC
Vinnytsia, Podolia Governorate, Ukraine
Countries
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References
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Halff EF, Rutigliano G, Garcia-Hidalgo A, Howes OD. Trace amine-associated receptor 1 (TAAR1) agonism as a new treatment strategy for schizophrenia and related disorders. Trends Neurosci. 2023 Jan;46(1):60-74. doi: 10.1016/j.tins.2022.10.010. Epub 2022 Nov 8.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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BP40283
Identifier Type: -
Identifier Source: org_study_id
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