SchizophreniaPhase 3PRISMA-3_OLENCT03870880
Study to Evaluate the Efficacy and Safety of Risperidone ISM® in Patients With Acute Schizophrenia: Open Label Extension
A Phase 3 study testing Risperidone ISM 75 mg and Risperidone ISM 100 mg in people with Schizophrenia, run by Rovi Pharmaceuticals Laboratories at 24 sites in 2 countries.
Trial summary
This is the long-term open label extension (OLE) of the study PRISMA-3 (NCT03160521). Those patients who complete participation in the main segment of the study (double blind) together with other clinically stable not previously enrolled (de novo patients) may opt to participate in this extension segment, where they… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Risperidone ISM 75 mg and Risperidone ISM 100 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- 24 sitesin 2 countries
- Study dates
- 25 Aug 2017to 8 Jan 2020
- Phase
- Phase 3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be eligible for entry into the extension segment of the study PRISMA-3, a patient must meet all of the following criteria at the extension baseline time point (immediately upon completion of the end-of-treatment visit assessments and procedures for the main part of the study):
- Has completed scheduled participation in the double blind segment of the study PRISMA-3, through to the end of the treatment period and including the end-of-treatment visit
- Continues to require long-term treatment with an antipsychotic medication, in the opinion of the investigator
- Continues to meet contraceptive requirements of the study PRISMA-3
- Is willing to participate in the extension segment of the study and remains capable of providing informed consent
- A signed informed consent form must be provided before any study assessments are performed for the extension segment
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- Continues to reside in a stable living situation, in the opinion of the investigator
- Continues to have an identified reliable informant, in the opinion of the investigator
- Capable of providing informed consent
- Age ≥ 18 and ≤ 65 years old
- On a stable dose of oral risperidone from 4 to 6 mg daily as maintenance therapy for at least the last 4 weeks prior/before screening/baseline and would potentially benefit from conversion to an extended release injectable, in the opinion of the investigator
- Current diagnosis of schizophrenia, according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria that is clinically stable as evidenced by:
- No hospitalizations for acute exacerbations of schizophrenia and psychiatrically stable without significant symptom exacerbation over the last 3 months before screening based on the investigator's judgment
- PANSS total score < 70 at screening
- CGI-S score of ≤ 3 (mild) at screening
- Has previously had a clinically significant beneficial response (improvement in schizophrenia symptoms), as determined by the investigator, to treatment with an antipsychotic medication other than clozapine
- At least 2 years elapsed since initial onset of active-phase schizophrenia symptoms
- Subject is outpatient; not hospitalized for worsening of schizophrenia within the last 3 months (hospitalization for social management within this time period is acceptable)
- Medically stable over the last month prior to screening based on the investigator's judgment
- BMI of 18.5 to 40.0 kg/m2 (inclusive) at screening
- Agrees to discontinue prohibited medications as applicable and as clinically indicated according to investigator instructions
- Dosages of all permitted medications are considered to have been stable (with the exception of medication to be used on an as-needed basis) for ≥ 2 weeks prior to the baseline visit and to remain stable during participation in this study
- Resides in a stable living situation, in the opinion of the investigator
- Has an identified reliable informant, in the opinion of the investigator
- Meets the contraceptive criteria stablished in the study
- Agrees not to post any personal medical data related to the study or information related to the study on any website or social media site during the study duration.
Who cannot join
- An individual who meets any of the following criteria at the extension baseline time point (immediately upon completion of the end-of-treatment visit assessments and procedures for the double blind segment PRISMA-3) will not be permitted to enter into this extension segment of the study PRISMA-3:
- Missed more than 1 scheduled study visit during participation in the double blind segment of study PRISMA-3
- Had an abnormal clinical laboratory value, vital sign, or ECG finding during participation in the main part of the study that, in the opinion of the investigator, was clinically relevant, related to study drug, and would compromise the well-being of the patient in the extension segment
- Had a clinically significant or unstable medical illness/condition/disorder during the main part of the study that would be anticipated, in the investigator's opinion, to potentially compromise patient safety in the extension segment
- Is taking or is anticipated to require any prohibited concomitant medication
- Pregnant, lactating, or breastfeeding
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- Any contraindication for continued IM injections (e.g., treatment with anticoagulant)
- Inadequate gluteal or deltoid musculature or excessive fat, as determined by the investigator, that would interfere with IM study drug injections
- Study site personnel and/or persons employed by the investigator or study site or is an immediate family member of such persons
- History of proven inadequate clinical response to treatment with therapeutic doses (with good compliance) of risperidone or paliperidone
- History of treatment resistance, defined as failure to respond to 2 discrete adequate trials (≥ 4 weeks with an adequate dose) of 2 different antipsychotic medications; history of clozapine use (exception: use was not because of treatment resistance or refractory psychotic symptoms)
- Known or suspected intolerance of or allergy or hypersensitivity to risperidone, paliperidone, or any of the excipients in the IM formulations of these
- History of neuroleptic malignant syndrome, clinically significant tardive dyskinesia or tardive dystonia
- History of any other medical condition that is considered to pose any unjustifiable risk or interfere with study assessments
- Clinically significant extrapyramidal symptoms at screening or baseline
- At significant risk of suicidal, homicidal or violent ideation or behavior, by history or as clinically assessed by the investigator at screening visit
- Answer of "yes" on item 4 or on item 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) (ideation) with the most recent episode occurring within the past 2 months, or answer "yes" to any of the 5 items (behavior) with an episode occurring within the last year
- Current diagnosis or a history of substance use disorder according to DSM-5 criteria within 6 months prior to the screening visit (with the exception of tobacco, mild cannabis, or mild alcohol use disorder) or a positive drug screen test (with the exception of cannabis) verified by repeat testing
- Lifetime history of diagnosis of schizoaffective disorder or bipolar disorder
- Clinically significant comorbid neuropsychiatric disorders
- Clinically significant or unstable medical illness/condition/disorder that would be anticipated, in the investigator's opinion, to potentially compromise patient safety or adversely affect the evaluation of efficacy
- Laboratory abnormality that, in the opinion of the investigator, would compromise the well-being of the patient, or any of the following laboratory abnormalities at screening or baseline
- Pregnant, lactating, or breastfeeding
- Inadequate gluteal or deltoid musculature or excessive fat, as determined by the investigator, that would interfere with IM study drug injections
- Any contraindication for IM injections
- Receipt of any long-acting antipsychotic medication by IM injection within 60 days before screening
- Current involuntary hospitalization or incarceration
- Hospitalized for more than 30 days during the 90 days before screening
- Participation in another clinical study in which the patient received an experimental or investigational drug or agent within 6 months before screening
- Participation in a clinical study with Risperidone ISM within 12 months before screening
- Study site personnel and/or persons employed by the investigator or study site or is an immediate family member of such persons
- Patients taking or anticipated to require any prohibited concomitant medication
Trial locations and contacts
24 sites in 2 countries.
24 sites in 2 countries
United States13 sites
Hassman Research Institute
Berlin, New Jersey, 08009
Midwest Clinical Research Center
Dayton, Ohio, 45417
InSite Clinical Research
DeSoto, Texas, 75115
CBH Health LLC
Gaithersburg, Maryland, 20877
Collaborative Neuroscience Network, LLC.
Garden Grove, California, 92845
Galiz Research
Hialeah, Florida, 33016
Innovative Clinical Research Inc.
Hollywood, Florida, 33021
Altea Research Institute
Las Vegas, Nevada, 89102
Apostle Clinical Trials Inc.
Long Beach, California, 90813
NRC Research Institute
Orange, California, 92868
CNRI-Los Angeles LLC
Pico Rivera, California, 90660
Woodland Research Northwest
Rogers, Arkansas, 72758
CNRI-San Diego
San Diego, California, 92112
Ukraine11 sites
Regional Clinical Hospital n.a I.I. Mechnicov
Dnipro, 49005
Kharkiv Regional Clinical Psychiatric Hospital
Kharkiv, 61068
Public Healthcare Institution "Kharkiv Regional Clinical Psychiatric Hospital No. 3", Center of Urgent Psychiatry
Kharkiv, 61068
Kherson Regional Psychiatric Hospital
Kherson, 73488
Kiev City Psychiatric Hospital No. 2
Kiev, 02192
Kyiv Regional Medical Association "Psykhiatriya" in Kyiv
Kiev, 04080
CI Lviv Regional Clinical Psychiatric Hospital. Department 20
Lviv, 79021
CI Lviv Regional Clinical Psychiatric Hospital. Department 25
Lviv, 79021
Odesa Regional Medical Centre of Mental Health
Odesa, 65006
Maltsev Regional Clinical Psychiatric Ho
Poltava, 36013
N.I. Pyrogov Vinnytsya Natl Medical University
Vinnytsia, 21005
About this study
Official title: Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Intramuscular Injections of Risperidone ISM® in Patients With Acute Exacerbation of Schizophrenia: Open Label Extension (PRISMA-3_OLE)
This is the long-term open label extension (OLE) of the study PRISMA-3 (NCT03160521). Those patients who complete participation in the main segment of the study (double blind) together with other clinically stable not previously enrolled (de novo patients) may opt to participate in this extension segment, where they will receive active Risperidone ISM® (75 mg or 100 mg)under open-label conditions every four weeks for approximately 12 months.
Read the detailed description
Patients who have completed planned participation in the double-blind segment of the study PRISMA-3 (NCT03160521) through to the end of the treatment period, may be eligible to enter into this optional long-term extension segment of the study. During this extension, open-label Risperidone ISM® (i.e., either 75 or 100 mg) will be administered to all participating patients once every 4 weeks for approximately 12 months. Patients who enter into the extension segment of the study will begin participation in the extension segment immediately upon completion of the end-of-treatment visit assessments and procedures.
In addition to patients continuing from the double-blind segment of the study PRISMA-3 (rollover patients), clinically stable patients not previously enrolled in the study (de novo patients) may be eligible to enter the long-term extension segment of the study. These patients will be evaluated for eligibility at a screening visit and, if eligible, will be allocated to receive either 75 or 100 mg Risperidone ISM every 4 weeks for approximately 12 months.
Approximately 100 de novo patients are planned to be enrolled in the extension segment of the study, in addition to rollover patients.
- Conditions
- Schizophrenia
- Being tested
- Risperidone ISM 75 mg, Risperidone ISM 100 mg
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risperidone ISM 75 mgDrug
Monthly (once every 4 weeks) intramuscular (IM) injection in the gluteal or deltoid muscle.
Risperidone ISM 100 mgDrug
Monthly (once every 4 weeks) IM injection in the gluteal or deltoid muscle.
| Study group | Role | What they receive |
|---|---|---|
| Risperidone ISM 75 mg | Experimental | Patients assigned to this arm will receive 75 mg of Risperidone ISM during the open label extensión (OLE).
Patients enter the study as rollover patients from the study NCT03160521, along with newly enrolled de novo patients. Receives: Drug: Risperidone ISM 75 mg |
| Risperidone ISM 100 mg | Experimental | Patients assigned to this arm will receive 100 mg of Risperidone ISM during the open label extensión (OLE).
Patients enter the study as rollover patients from the study NCT03160521, along with newly enrolled de novo patients. Receives: Drug: Risperidone ISM 100 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
PANSS Total Score Mean Change From Baseline to Endpoint
The Positive and Negative Syndrome Scale (PANSS) is a 30-item clinician-rated instrument for assessing the symptoms of schizophrenia.The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score is the sum of all 30 PANSS items and ranges from 30 to 210, with 30 indicating absence of symptoms of schizophrenia and 210 indicating extreme ratings of all 30 symptoms. Negative change from baseline scores indicates improvements in symptoms whereas higher scores mean a worse outcome.
Endpoint is defined as study day 365 or the last post-baseline assessment if early discontinuation.
Measured: Baseline and Day 365 (or the last post-baseline assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start25 Aug 2017
- Primary completion8 Jan 2020
- Study completion8 Jan 2020
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 SchizophreniaStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rovi Pharmaceuticals Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Litman, Principal investigator, CBH Health LLCYuriy Filts, Principal investigator, CI Lviv Regional Clinical Psychiatric Hospital. Department 25
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03870880
- Sponsor's protocol ID
- ROV-RISP-2016-01_OLE
- Acronym
- PRISMA-3_OLE
- Status last verified
- Mar 2019
- First submitted
- 26 Feb 2019
- Last updated
- 25 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Filts Y, Litman RE, Martinez J, Anta L, Naber D, Correll CU. Long-term efficacy and safety of once-monthly Risperidone ISM(R) in the treatment of schizophrenia: Results from a 12-month open-label extension study. Schizophr Res. 2022 Jan;239:83-91. doi: 10.1016/j.schres.2021.11.030. Epub 2021 Nov 27.
PubMed 34847501
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Intramuscular Injections of Risperidone ISM® in Patients With Acute Exacerbation of Schizophrenia: Open Label Extension (PRISMA-3_OLE)
- ClinicalTrials.gov ID
- NCT03870880
- Acronym / sponsor ID
- PRISMA-3_OLE / ROV-RISP-2016-01_OLE
- Conditions
- Schizophrenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- Rovi Pharmaceuticals LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- 25 Aug 2017 (actual)
- Primary completion
- 8 Jan 2020 (actual)
- Study completion
- 8 Jan 2020 (actual)
- First posted
- 12 Mar 2019 (actual)
- Results
- Posted 23 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is the long-term open label extension (OLE) of the study PRISMA-3 (NCT03160521). Those patients who complete participation in the main segment of the study (double blind) together with other clinically stable not previously enrolled (de novo patients) may opt to participate in this extension segment, where they will receive active Risperidone ISM® (75 mg or 100 mg)under open-label conditions every four weeks for approximately 12 months.
Detailed description
Patients who have completed planned participation in the double-blind segment of the study PRISMA-3 (NCT03160521) through to the end of the treatment period, may be eligible to enter into this optional long-term extension segment of the study. During this extension, open-label Risperidone ISM® (i.e., either 75 or 100 mg) will be administered to all participating patients once every 4 weeks for approximately 12 months. Patients who enter into the extension segment of the study will begin participation in the extension segment immediately upon completion of the end-of-treatment visit assessments and procedures.
In addition to patients continuing from the double-blind segment of the study PRISMA-3 (rollover patients), clinically stable patients not previously enrolled in the study (de novo patients) may be eligible to enter the long-term extension segment of the study. These patients will be evaluated for eligibility at a screening visit and, if eligible, will be allocated to receive either 75 or 100 mg Risperidone ISM every 4 weeks for approximately 12 months.
Approximately 100 de novo patients are planned to be enrolled in the extension segment of the study, in addition to rollover patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Risperidone ISM 75 mg | Experimental | Drug: Risperidone ISM 75 mgPatients assigned to this arm will receive 75 mg of Risperidone ISM during the open label extensión (OLE). Patients enter the study as rollover patients from the study NCT03160521, along with newly enrolled de novo patients. |
| Risperidone ISM 100 mg | Experimental | Drug: Risperidone ISM 100 mgPatients assigned to this arm will receive 100 mg of Risperidone ISM during the open label extensión (OLE). Patients enter the study as rollover patients from the study NCT03160521, along with newly enrolled de novo patients. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- To be eligible for entry into the extension segment of the study PRISMA-3, a patient must meet all of the following criteria at the extension baseline time point (immediately upon completion of the end-of-treatment visit assessments and procedures for the main part of the study):
- Has completed scheduled participation in the double blind segment of the study PRISMA-3, through to the end of the treatment period and including the end-of-treatment visit
- Continues to require long-term treatment with an antipsychotic medication, in the opinion of the investigator
- Continues to meet contraceptive requirements of the study PRISMA-3
- Is willing to participate in the extension segment of the study and remains capable of providing informed consent
Key exclusion criteria (32 listed)
- An individual who meets any of the following criteria at the extension baseline time point (immediately upon completion of the end-of-treatment visit assessments and procedures for the double blind segment PRISMA-3) will not be permitted to enter into this extension segment of the study PRISMA-3:
- Missed more than 1 scheduled study visit during participation in the double blind segment of study PRISMA-3
- Had an abnormal clinical laboratory value, vital sign, or ECG finding during participation in the main part of the study that, in the opinion of the investigator, was clinically relevant, related to study drug, and would compromise the well-being of the patient in the extension segment
- Had a clinically significant or unstable medical illness/condition/disorder during the main part of the study that would be anticipated, in the investigator's opinion, to potentially compromise patient safety in the extension segment
- Is taking or is anticipated to require any prohibited concomitant medication
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 |
|---|---|---|
| Risperidone ISM 75 mgMonthly (once every 4 weeks) intramuscular (IM) injection in the gluteal or deltoid muscle. | Drug | Risperidone ISM 75 mg |
| Risperidone ISM 100 mgMonthly (once every 4 weeks) IM injection in the gluteal or deltoid muscle. | Drug | Risperidone ISM 100 mg |
Primary outcome
PANSS Total Score Mean Change From Baseline to Endpoint
Time frame: Baseline and Day 365 (or the last post-baseline assessment)
The Positive and Negative Syndrome Scale (PANSS) is a 30-item clinician-rated instrument for assessing the symptoms of schizophrenia.The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score is the sum of all 30 PANSS items and ranges from 30 to 210, with 30 indicating absence of symptoms of schizophrenia and 210 indicating extreme ratings of all 30 symptoms. Negative change from baseline scores indicates improvements in symptoms whereas higher scores mean a worse outcome. Endpoint is defined as study day 365 or the last post-baseline assessment if early discontinuation.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 34847501Filts Y, Litman RE, Martinez J, Anta L, Naber D, Correll CU. Long-term efficacy and safety of once-monthly Risperidone ISM(R) in the treatment of schizophrenia: Results from a 12-month open-label extension study. Schizophr Res. 2022 Jan;239:83-91. doi: 10.1016/j.schres.2021.11.030. Epub 2021 Nov 27.
- Individual participant dataSharing planned: No
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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.
Robert Litman principal investigator
CBH Health LLC
Yuriy Filts principal investigator
CI Lviv Regional Clinical Psychiatric Hospital. Department 25
24 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Risperidone ISM 75 mg and Risperidone ISM 100 mg in people with Schizophrenia, run by Rovi Pharmaceuticals Laboratories at 24 sites in 2 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 26 inclusion and 32 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 25 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, Ukraine. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 23 Feb 2022). 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?
PANSS Total Score Mean Change From Baseline to Endpoint (time frame: Baseline and Day 365 (or the last post-baseline assessment)). 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 NCT03870880, 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 25 Mar 2022.