SchizophreniaPhase 1PRISMA-1NCT01788774
Pharmacokinetic, Safety, and Tolerability Study of Risperidone ISM® at Different Dose Strengths
A Phase 1 study testing Risperidone ISM 50 mg, Risperidone ISM 75 mg and Risperidone ISM 100 mg in people with Schizophrenia and Schizoaffective Disorder, run by Rovi Pharmaceuticals Laboratories at 5 sites in 4 countries.
Trial summary
This clinical trial is designed to evaluate different dosages of risperidone ISM, a new long-acting injectable form. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Risperidone ISM 50 mg, Risperidone ISM 75 mg and Risperidone ISM 100 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 5 sitesin 4 countries
- Study dates
- Apr 2013to Feb 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Capable of providing informed consent.
- Male or female aged ≥ 18 years to < 65 years
- Current diagnosis of schizophrenia or schizoaffective disorder, according to the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders Clinical Trials (SCID-CT) or the DSM-IV-TR
- Medically stable over the last month, and psychiatrically stable without significant symptom exacerbation over the last three months based on the investigator's judgment
- Score of ≤ 4 (moderately ill) on the Clinical Global Impression - Severity of Illness (CGI-S)
- If a sexually active female of childbearing potential, using a medically accepted contraceptive method.
Who cannot join
- Presence of an uncontrolled, unstable, clinically significant medical condition that in the opinion of the investigator may interfere with the interpretation of safety and PK evaluations
- If female, a positive serum pregnancy test, or planning to become pregnant between now and one month after the last dose of trial medication, or currently breastfeeding a child
- History of neuroleptic malignant syndrome and current or past history of tardive dyskinesia
- Positive urine drug/alcohol screen finding, unless the positive finding can be accounted for by documented prescription use.
- In the investigator's opinion, at imminent risk of committing self-harm
- Use of depot antipsychotics within the last three months
- Receipt of any investigational drugs within the last three months
- Current participation in any other clinical trial
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
About this study
Official title: Phase I, Open-Label, Randomized, Parallel Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of One Intramuscular Injection of Risperidone ISM® at Different Dose Strengths in Subjects With Schizophrenia or Schizoaffective Disorder
This clinical trial is designed to evaluate different dosages of risperidone ISM, a new long-acting injectable form.
Read the detailed description
This clinical trial will try to characterize and document the pharmacokinetics of risperidone ISM in schizophrenic or schizoaffective patients after one intramuscular injection at different dose strengths.Likewise, the safety and tolerability of risperidone ISM will be evaluated in the above mentioned population.
Following confirmation of eligibility and a washout period for study-prohibited drugs, a total of 33 subjects will be randomized in a 1:1:1 ratio to receive a single intramuscular (IM) injection of one of the following dosages of study drug:
Group 1: 50 mg risperidone ISM Group 2: 75 mg risperidone ISM Group 3: 100 mg risperidone ISM Several blood samples for plasma pharmacokinetic (PK) assessments will be obtained pre-dose and post-dose. Safety assessments will be conducted at each pre-specified time points.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Risperidone ISM 50 mg, Risperidone ISM 75 mg, Risperidone ISM 100 mg
- Keywords
- Pharmacokinetics, Safety, Risperidone ISM®, Intramuscular, Schizophrenia
- 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.
Risperidone ISM 50 mgDrug
Risperidone ISM 75 mgDrug
Risperidone ISM 100 mgDrug
| Study group | Role | What they receive |
|---|---|---|
| Risperidone ISM 50mg | Other | Three different single doses will be evaluated Receives: Drug: Risperidone ISM 50 mg |
| Risperidone ISM 75mg | Other | Three different single doses will be evaluated Receives: Drug: Risperidone ISM 75 mg |
| Risperidone ISM 100mg | Other | Three different single doses will be evaluated Receives: Drug: Risperidone ISM 100 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve
Measured: Pre-dose and 18 time points Post-dose will be carried out within a 75 day time frame
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2013 (estimated)
- Study startApr 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rovi Pharmaceuticals Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01788774
- Sponsor's protocol ID
- ROV-RISP-2011-01
- Other IDs
- 2012-003303-35
- Acronym
- PRISMA-1
- Status last verified
- Oct 2014
- First submitted
- 5 Feb 2013
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Open-Label, Randomized, Parallel Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of One Intramuscular Injection of Risperidone ISM® at Different Dose Strengths in Subjects With Schizophrenia or Schizoaffective Disorder
- ClinicalTrials.gov ID
- NCT01788774
- Acronym / sponsor ID
- PRISMA-1 / ROV-RISP-2011-01
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- Pharmacokinetics, Safety, Risperidone ISM®, Intramuscular, Schizophrenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Rovi Pharmaceuticals LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 11 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial is designed to evaluate different dosages of risperidone ISM, a new long-acting injectable form.
Detailed description
This clinical trial will try to characterize and document the pharmacokinetics of risperidone ISM in schizophrenic or schizoaffective patients after one intramuscular injection at different dose strengths.Likewise, the safety and tolerability of risperidone ISM will be evaluated in the above mentioned population.
Following confirmation of eligibility and a washout period for study-prohibited drugs, a total of 33 subjects will be randomized in a 1:1:1 ratio to receive a single intramuscular (IM) injection of one of the following dosages of study drug:
Group 1: 50 mg risperidone ISM Group 2: 75 mg risperidone ISM Group 3: 100 mg risperidone ISM Several blood samples for plasma pharmacokinetic (PK) assessments will be obtained pre-dose and post-dose. Safety assessments will be conducted at each pre-specified time points.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Risperidone ISM 50mg | Other | Drug: Risperidone ISM 50 mgThree different single doses will be evaluated |
| Risperidone ISM 75mg | Other | Drug: Risperidone ISM 75 mgThree different single doses will be evaluated |
| Risperidone ISM 100mg | Other | Drug: Risperidone ISM 100 mgThree different single doses will be evaluated |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Capable of providing informed consent.
- Male or female aged ≥ 18 years to < 65 years
- Current diagnosis of schizophrenia or schizoaffective disorder, according to the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders Clinical Trials (SCID-CT) or the DSM-IV-TR
- Medically stable over the last month, and psychiatrically stable without significant symptom exacerbation over the last three months based on the investigator's judgment
- Score of ≤ 4 (moderately ill) on the Clinical Global Impression - Severity of Illness (CGI-S)
Key exclusion criteria (8 listed)
- Presence of an uncontrolled, unstable, clinically significant medical condition that in the opinion of the investigator may interfere with the interpretation of safety and PK evaluations
- If female, a positive serum pregnancy test, or planning to become pregnant between now and one month after the last dose of trial medication, or currently breastfeeding a child
- History of neuroleptic malignant syndrome and current or past history of tardive dyskinesia
- Positive urine drug/alcohol screen finding, unless the positive finding can be accounted for by documented prescription use.
- In the investigator's opinion, at imminent risk of committing self-harm
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 50 mg | Drug | Risperidone ISM 50mg |
| Risperidone ISM 75 mg | Drug | Risperidone ISM 75mg |
| Risperidone ISM 100 mg | Drug | Risperidone ISM 100mg |
Primary outcome
Area under the curve
Time frame: Pre-dose and 18 time points Post-dose will be carried out within a 75 day time frame
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Risperidone ISM 50 mg, Risperidone ISM 75 mg and Risperidone ISM 100 mg in people with Schizophrenia and Schizoaffective Disorder, run by Rovi Pharmaceuticals Laboratories at 5 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 6 inclusion and 8 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 23 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 5 sites in Russia, Croatia, South Africa, Spain. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Area under the curve (time frame: Pre-dose and 18 time points Post-dose will be carried out within a 75 day time frame). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Oct 2023.