Schizophrenia, Schizoaffective DisorderPhase 2NCT04512066
A Trial of the Efficacy and the Safety of RO6889450 (Ralmitaront) vs Placebo in Patients With an Acute Exacerbation of Schizophrenia or Schizoaffective Disorder
A Phase 2 study testing RO6889450 and Risperidone in people with Schizophrenia, Schizoaffective Disorder, run by Hoffmann-La Roche at 40 sites in 4 countries.
Trial summary
This study will investigate the efficacy and safety of RO6889450 as monotherapy in participants experiencing an acute exacerbation of symptoms of schizophrenia or schizoaffective disorder. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- RO6889450 and Risperidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 287 participants
- Where
- 40 sitesin 4 countries
- Study dates
- 8 Sep 2020to 21 Jun 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participant must be 18 to 45 years of age inclusive
- Participants with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of schizophrenia or schizoaffective disorder as confirmed by the Mini International Neuropsychiatric Interview (MINI)
- Disease duration </=10 years
- Have a current acute exacerbation of schizophrenia of no more than 8 weeks before screening visit and no current signs of apparent lack of treatment response
- At the time of screening, the participant needs to be either hospitalized or requiring inpatient psychiatric care according to clinical judgment. If the participant has been hospitalized for the current exacerbation, the hospitalization has to be of a maximum of 1 week prior to screening.
- In previous exacerbations and hospitalizations, the subject has shown a pattern of response to appropriate antipsychotic treatment
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- Medically stable over a period of 3 months (non-psychiatric conditions) prior to screening visit and not expected to require hospitalization or change of treatment for non-psychiatric conditions for the duration of the study
- Screening and baseline CGI-S >/=4 (moderate or worse)
- Screening and baseline PANSS total score >= 80
- Based on screening and baseline PANSS, scores of >/= 4 (moderate or worse) on 2 or more of the following items: delusions, conceptual disorganization, unusual thought content, hallucinatory behavior, or suspiciousness/persecution
- Body mass index between 18 and 35 kg/m2 inclusive
- Male and female participants; female participants 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
- Additional inclusion criteria for optional 36-Week Safety Extension Phase
- Successful completion of the 12-week treatment period
- No signs or symptoms of worsening of the psychiatric or medical status that would preclude the patient from the participation in the 36-Week Safety Extension Phase or affect their ability to comply with the study requirements.
Who cannot join
- Has been inpatient for > 1 week or had any other hospitalization for acute exacerbation of schizophrenia or schizoaffective disorder within the prior 8 weeks or signs of lack of response to antipsychotic treatment
- Disease duration > 10 years
- Is currently an inpatient on an involuntary basis
- Subject answers "yes" to "Suicidal Ideation" Item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) or any suicidal behavior on the Columbia-Suicide Severity Rating Scale (C-SSRS) assessment within one month from screening or between screening and baseline
- Lifetime history of homicidal behavior
- Moderate to severe substance use disorder within six months (excluding nicotine) as defined by DSM-5
Show all 22Show fewer
- Other current DSM-5 diagnosis (e.g., bipolar disorder, major depressive disorder)
- A prior or current general medical condition that might be impairing cognition or other psychiatric functioning (e.g., migraine headaches requiring prophylaxis treatment, head trauma, dementia, seizure disorder, stroke; or neurodegenerative, inflammatory, infectious, neoplastic, toxic, metabolic, or endocrine conditions)
- Clinically significant abnormalities in laboratory safety test results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis), including a) Aspartate aminotransferase (AST), OR alanine aminotransferase (ALT) 2 x upper limit of normal (ULN), OR total bilirubin > 1.5 ULN with the exception of known Gilbert syndrome. b) Serum creatinine > 1.5 ULN
- Positive result at screening for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV, untreated), or human immunodeficiency virus (HIV)-1 and -2. HCV participants who have been successfully treated and who test negative for HCV RNA are eligible for entry into the study
- Tardive dyskinesia that is moderate to severe or requires treatment
- History of neuroleptic malignant syndrome
- Average triplicate QTcF interval greater than 450 msec for males and 470 msec for females or other clinically significant abnormality on screening ECG based on centralized reading
- Participant for whom risperidone is contraindicated or who have a documented history of lack of response or intolerance to risperidone or paliperidone or participants with known hypersensitivity to risperidone, paliperidone, or to any excipients in Risperdal
- Participant treated with a long acting injectable antipsychotic or other antipsychotics that cannot be washed-out within the allotted screening period
- History of electro-convulsive therapy (ECT) for any reason
- Participant treated with clozapine at any dose within 12 months of screening visit or participants treated with clozapine at 200 mg/day or above at any time; low dose (< 200mg/day) use for insomnia or dyskinesia longer than 12 months prior to screening visit is permitted
- Participants currently receiving a psychotropic or other medication used as a psychotropic, which cannot be discontinued during the screening period
- Positive urine drug screen for amphetamines, methamphetamines, opiates, buprenorphine, methadone, cocaine and barbiturates. In case of positive urine drug screen for cannabinoids, the participant may be allowed to enter the study if approved by Medical Monitor
- Participant has previously received RO6889450
- Participant received an investigational drug within 28 days or five times the half-life of the investigational drug prior to the first study drug administration
- 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
Trial locations and contacts
40 sites in 4 countries.
40 sites in 4 countries
United States24 sites
Atlanta Center For Medical Research
Atlanta, Georgia, 30331
Community Clinical Research Inc.
Austin, Texas, 78754
CITrials, Inc.
Bellflower, California, 90706
Neuro-Behavioral Clinical Research, Inc.
Canton, Ohio, 44718
Uptown Research Institute
Chicago, Illinois, 60640
ProScience Research Group
Culver City, California, 90230
Midwest Clinical Research Center - ERG - PPDS
Dayton, Ohio, 45415
CBH Health LLC
Gaithersburg, Maryland, 20877
Collaborative Neuroscience Network, Inc.
Garden Grove, California, 92845
Pillar Clinical Research LLC
Garland, Texas, 75042
California Clinical Trials Medical Group managed by Parexel
Glendale, California, 91206
Galiz Research, LLC
Hialeah, Florida, 33016
Innovative Clinical Research, Inc.
Lauderhill, Florida, 33319
Synergy San Diego
Lemon Grove, California, 91945
Woodland International Research Group Inc.
Little Rock, Arkansas, 72211
Premier Clinical Research Institute - Miami - BTC - PPDS
Miami, Florida, 33122
Research Centers of America - ERG
Oakland Park, Florida, 33334
NRC Research Institute
Orange, California, 92868
ASCLEPES Research Centers
Panorama City, California, 91402
CNRI - Los Angeles, LLC
Pico Rivera, California, 90660
CITrials, Inc.
Riverside, California, 92506
California Neuropsychopharmacology Clinical Research Institute, LLC
San Diego, California, 92102
Artemis Institute For Clinical Research LLC - San Diego - ClinEdge - PPDS
San Diego, California, 92103
Schuster Medical Research Institute
Sherman Oaks, California, 91403
Russia8 sites
Psychiatry Hospital #1 n.a. P.P.Kashchenko
Saint Petersburg, Sankt-Peterburg, 188357
Leningradskiy Regional Psychoneurologic Dispensary
Saint Petersburg, Sankt-Peterburg, 188820
Psychiatric Hospital St Nicholas the Wonderworker
Saint Petersburg, Sankt-Peterburg, 190121
City Psychiatry Hospital #3 n.a. I.I. Skvortsov-Stepanov
Saint Petersburg, Sankt-Peterburg, 197341
FSBI National Medical Research Centre of Psychiatry and Neurology n.a. V.M. Bekhterev of MoH of RF
Sankt-peterburg, Vladimirskaya Oblast’, 192019
Saratov regional clinical psychoneurological hospital St Sofii
Saratov, 410060
Stavropol Regional Psychiatry Hospital #2
Stavropol, 357034
Tomsk National Scientific Medical Center of Russian Academy of Sciences
Tomsk, 634009
Ukraine6 sites
Communal Non-Commercial Enterprise of Kharkiv RC Regional clinical psychiatric hospital #3
Kharkiv, Kharkiv Governorate, 61068
Public NPE Kherson Regional Institution of Mental Care of Kherson RC
Kherson, Kherson Governorate, 73488
Kyiv Medical Regional Union Psychiatry
Kylv, KIEV Governorate, 04080
Poltava Regional Psychiatry Hospital
Poltava, Poltava Governorate, 36030
Communal Non-Commercial Enterprise Cherkasy Regional Psychiatric Hospital of Cherkasy RC
Smila, KIEV Governorate, 20708
Communal NPE Vinnytsia Reg. Clin. Psychoneurolog. Hosp. n.a. O.I. Yushchenko of Vinnytsia RC
Vinnytsia, Podolia Governorate, 21037
Japan2 sites
National Center of Neurology and Psychiatry
Tokyo, 187-8551
Seishinkai Okehazama Hospital Fujita Kokoro Care Center
Toyoake, 470-1168
About this study
Official title: A Phase II, Multi-Center, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Trial of the Efficacy and the Safety of RO6889450 (Ralmitaront) vs Placebo in Patients With an Acute Exacerbation of Schizophrenia or Schizoaffective Disorder
This study will investigate the efficacy and safety of RO6889450 as monotherapy in participants experiencing an acute exacerbation of symptoms of schizophrenia or schizoaffective disorder.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- RO6889450, Placebo, Risperidone
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO6889450Drug
Participants will receive oral RO6889450 QD.
PlaceboDrug
Participants will receive oral placebo QD.
RisperidoneDrug
Participants will receive oral risperidone QD.
| Study group | Role | What they receive |
|---|---|---|
| 150 mg Once Daily (QD) RO6889450 | Experimental | Participants will receive 150 mg of RO6889450 QD for 4 weeks or 12 weeks or 48 weeks. Receives: Drug: RO6889450 |
| 45 mg QD RO6889450 | Experimental | Participants will receive 45 mg of RO6889450 QD for 4 weeks or 12 weeks or 48 weeks. Receives: Drug: RO6889450 |
| Placebo | Placebo comparator | Participants will receive oral placebo QD for 4 weeks. Participants from this arm that continue to the extension period will be randomized to either 45 mg or 150 mg QD of RO6889450 for up to an additional 8 weeks or additional 44 weeks (optional 36-Week Safety Extension Phase). Receives: Drug: Placebo |
| 4 mg QD Risperidone | Active comparator | Participants will receive 4 mg of risperidone QD for 4 weeks or 12 weeks or 48 weeks. Receives: Drug: Risperidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4
The PANSS is a 30-item rating scale that evaluates positive, negative, and other symptoms in patients with schizophrenia. The Positive subscale is a 7-item scale that assesses features in schizophrenia that are not present in a normal mental state. The Negative subscale is a 7-item scale that assesses features absent in schizophrenia but present in those with a normal mental state. Items are rated on a 7-point scale, where 1 = absent and 7 = extreme, for a maximum score of 49 for each scale. The General subscale is a 16-item scale that assesses the overall severity of schizophrenia and the risk of aggression. Items are rated on the same scale, with a minimum score of 16 and a maximum score of 112. Total scores are calculated by adding subscale scores together, for a minimum score of 30 and a maximum score of 210. Higher scores indicate higher severity.
Measured: Week 4 (Day 28)
Secondary outcomes (10)
Change From Baseline in PANSS Factor Scores at Week 4
PANSS factors are modified groupings of the 30 PANSS items from the original three subscales (positive, negative, and general psychopathology). Each item is rated on a scale of 1 (absent) to 7 (most extreme). The positive symptom factor contains 8 items (score range 8-56); the negative symptom and disorganized thought/cognition factors contain 7 items (score range 7-49); the uncontrolled hostility/excitement, expressive deficit, and anxiety/depression factors contain 4 items (score range 4-28); and the avolition domain contains 3 items (score range 3-21). The negative and positive totals each have a range of 7-49 and the general total has a range of 16-112. Higher scores indicate higher symptom severity.
Measured: Week 4 (Day 28)
Proportion of Participants With at Least 20% or 50% Improvement From Baseline in the PANSS Total Score
The PANSS is a 30-item rating scale that evaluates positive, negative, and other symptoms in patients with schizophrenia. The Positive subscale is a 7-item scale that assesses features in schizophrenia that are not present in a normal mental state. The Negative subscale is a 7-item scale that assesses features absent in schizophrenia but present in those with a normal mental state. Items are rated on a 7-point scale, where 1 = absent and 7 = extreme, for a maximum score of 49 for each scale. The General subscale is a 16-item scale that assesses the overall severity of schizophrenia and the risk of aggression. Items are rated on the same scale, with a minimum score of 16 and a maximum score of 112. Total scores are calculated by adding subscale scores together, for a minimum score of 30 and a maximum score of 210. Higher scores indicate higher severity.
Measured: Baseline to Week 12
Change From Baseline in Clinical Global Impression Severity (CGI-S) Scores
The CGI-S measures global severity of illness at a given point in time using a 7-point scale, where 1 = no symptoms and 7 = very severe symptoms.
Measured: Week 4 (Day 28)
Clinical Global Impression - Improvement (CGI-I) Scores
The CGI-I measures change from the baseline state at subsequent visits using a 7-point scale, where 1 = very much improved and 7 = very much worse.
Measured: Week 4 (Day 28)
PANSS Total Score at Week 12
The PANSS is a 30-item rating scale that evaluates positive, negative, and other symptoms in patients with schizophrenia. The Positive subscale is a 7-item scale that assesses features in schizophrenia that are not present in a normal mental state. The Negative subscale is a 7-item scale that assesses features absent in schizophrenia but present in those with a normal mental state. Items are rated on a 7-point scale, where 1 = absent and 7 = extreme, for a maximum score of 49 for each scale. The General subscale is a 16-item scale that assesses the overall severity of schizophrenia and the risk of aggression. Items are rated on the same scale, with a minimum score of 16 and a maximum score of 112. Total scores are calculated by adding subscale scores together, for a minimum score of 30 and a maximum score of 210. Higher scores indicate higher severity.
Measured: Week 12
Proportion of Participants With at Least 20% or 50% Improvement in the PANSS Total Score up to Week 12
The PANSS is a 30-item rating scale that evaluates positive, negative, and other symptoms in patients with schizophrenia. The Positive subscale is a 7-item scale that assesses features in schizophrenia that are not present in a normal mental state. The Negative subscale is a 7-item scale that assesses features absent in schizophrenia but present in those with a normal mental state. Items are rated on a 7-point scale, where 1 = absent and 7 = extreme, for a maximum score of 49 for each scale. The General subscale is a 16-item scale that assesses the overall severity of schizophrenia and the risk of aggression. Items are rated on the same scale, with a minimum score of 16 and a maximum score of 112. Total scores are calculated by adding subscale scores together, for a minimum score of 30 and a maximum score of 210. Higher scores indicate higher severity.
Measured: Weeks 4, 8, and 12
CGI-S up to Week 12
The CGI-S measures global severity of illness at a given point in time using a 7-point scale, where 1 = no symptoms and 7 = very severe symptoms.
Measured: Up to Week 12
CGI-I up to Week 12
The CGI-I measures change from the baseline state at subsequent visits using a 7-point scale, where 1 = very much improved and 7 = very much worse.
Measured: Up to Week 12
Participants Ready for Discharge From First Randomized Treatment Intake to Readiness for Discharge as Assessed by the Readiness for Discharge Questionnaire (RDQ) at 4-Week Treatment
The RDQ is a tool used to assess inpatients with schizophrenia on their readiness for discharge from inpatient treatment. It consists of five items that assess suicidality/homicidality, control of aggression/impulsivity, activities of daily living, medication-taking, and delusions/hallucinations interfering with functioning and global status. An additional item examines the overall clinical state of the patient and the final question assesses readiness for discharge. The values reported are the proportion (expressed as a percentage) of participants in each analysis group considered ready for discharge according to the RDQ.
Measured: after 4-week treatment
Plasma Concentration of RO6889450
Measured: Day 7 - Day 336
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start8 Sep 2020
- Primary completion21 Jun 2022
- Study completion21 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Schizophrenia, Schizoaffective DisorderStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04512066
- Sponsor's protocol ID
- BP41743
- Status last verified
- Sep 2023
- First submitted
- 12 Aug 2020
- Last updated
- 10 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).
Publications
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.
PubMed 36369028
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multi-Center, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Trial of the Efficacy and the Safety of RO6889450 (Ralmitaront) vs Placebo in Patients With an Acute Exacerbation of Schizophrenia or Schizoaffective Disorder
- ClinicalTrials.gov ID
- NCT04512066
- Acronym / sponsor ID
- BP41743
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 8 Sep 2020 (actual)
- Primary completion
- 21 Jun 2022 (actual)
- Study completion
- 21 Jun 2022 (actual)
- First posted
- 13 Aug 2020 (actual)
- Results
- Posted 10 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate the efficacy and safety of RO6889450 as monotherapy in participants experiencing an acute exacerbation of symptoms of schizophrenia or schizoaffective disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 150 mg Once Daily (QD) RO6889450 | Experimental | Drug: RO6889450Participants will receive 150 mg of RO6889450 QD for 4 weeks or 12 weeks or 48 weeks. |
| 45 mg QD RO6889450 | Experimental | Drug: RO6889450Participants will receive 45 mg of RO6889450 QD for 4 weeks or 12 weeks or 48 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive oral placebo QD for 4 weeks. Participants from this arm that continue to the extension period will be randomized to either 45 mg or 150 mg QD of RO6889450 for up to an additional 8 weeks or additional 44 weeks (optional 36-Week Safety Extension Phase). |
| 4 mg QD Risperidone | Active comparator | Drug: RisperidoneParticipants will receive 4 mg of risperidone QD for 4 weeks or 12 weeks or 48 weeks. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Participant must be 18 to 45 years of age inclusive
- Participants with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of schizophrenia or schizoaffective disorder as confirmed by the Mini International Neuropsychiatric Interview (MINI)
- Disease duration </=10 years
- Have a current acute exacerbation of schizophrenia of no more than 8 weeks before screening visit and no current signs of apparent lack of treatment response
- At the time of screening, the participant needs to be either hospitalized or requiring inpatient psychiatric care according to clinical judgment. If the participant has been hospitalized for the current exacerbation, the hospitalization has to be of a maximum of 1 week prior to screening.
Key exclusion criteria (22 listed)
- Has been inpatient for > 1 week or had any other hospitalization for acute exacerbation of schizophrenia or schizoaffective disorder within the prior 8 weeks or signs of lack of response to antipsychotic treatment
- Disease duration > 10 years
- Is currently an inpatient on an involuntary basis
- Subject answers "yes" to "Suicidal Ideation" Item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) or any suicidal behavior on the Columbia-Suicide Severity Rating Scale (C-SSRS) assessment within one month from screening or between screening and baseline
- Lifetime history of homicidal behavior
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RO6889450Participants will receive oral RO6889450 QD. | Drug | 150 mg Once Daily (QD) RO6889450, 45 mg QD RO6889450 |
| PlaceboParticipants will receive oral placebo QD. | Drug | Placebo |
| RisperidoneParticipants will receive oral risperidone QD. | Drug | 4 mg QD Risperidone |
Primary outcome
Mean Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4
Time frame: Week 4 (Day 28)
The PANSS is a 30-item rating scale that evaluates positive, negative, and other symptoms in patients with schizophrenia. The Positive subscale is a 7-item scale that assesses features in schizophrenia that are not present in a normal mental state. The Negative subscale is a 7-item scale that assesses features absent in schizophrenia but present in those with a normal mental state. Items are rated on a 7-point scale, where 1 = absent and 7 = extreme, for a maximum score of 49 for each scale. The General subscale is a 16-item scale that assesses the overall severity of schizophrenia and the risk of aggression. Items are rated on the same scale, with a minimum score of 16 and a maximum score of 112. Total scores are calculated by adding subscale scores together, for a minimum score of 30 and a maximum score of 210. Higher scores indicate higher severity.
10 secondary outcomes
Change From Baseline in PANSS Factor Scores at Week 4
Time frame: Week 4 (Day 28)
Proportion of Participants With at Least 20% or 50% Improvement From Baseline in the PANSS Total Score
Time frame: Baseline to Week 12
Change From Baseline in Clinical Global Impression Severity (CGI-S) Scores
Time frame: Week 4 (Day 28)
Clinical Global Impression - Improvement (CGI-I) Scores
Time frame: Week 4 (Day 28)
PANSS Total Score at Week 12
Time frame: Week 12
Proportion of Participants With at Least 20% or 50% Improvement in the PANSS Total Score up to Week 12
Time frame: Weeks 4, 8, and 12
CGI-S up to Week 12
Time frame: Up to Week 12
CGI-I up to Week 12
Time frame: Up to Week 12
Participants Ready for Discharge From First Randomized Treatment Intake to Readiness for Discharge as Assessed by the Readiness for Discharge Questionnaire (RDQ) at 4-Week Treatment
Time frame: after 4-week treatment
Plasma Concentration of RO6889450
Time frame: Day 7 - Day 336
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36369028Halff 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.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
40 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RO6889450 and Risperidone in people with Schizophrenia, Schizoaffective Disorder, run by Hoffmann-La Roche at 40 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States, Russia, Ukraine, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4 (time frame: Week 4 (Day 28)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04512066, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.