A Phase 1 interventional study of Risperidone ISM 50 mg and Risperidone ISM 75 mg in Schizophrenia and Schizoaffective Disorder, sponsored by Rovi Pharmaceuticals Laboratories. Completed at 5 sites in 4 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-10-23.
Sponsored by Rovi Pharmaceuticals Laboratories · Phase 1, Interventional, and Treatment
Among 127 studies testing risperidone in Schizophrenia — 4 open to participants now, 4 under way, 2 of them phase 3. Risperidone · Schizophrenia.
Among the 127 studies testing risperidone in Schizophrenia, this one is the 97th largest by enrollment of the 123 interventional ones that give a count, is one of 5 that started in 2013, is one of 12 in phase 1, and was the 84th registered.
3,565 studies on the registry are indexed under Schizophrenia; 492 are open to participants now.
Browse Schizophrenia studies →4 of the 127 studies testing risperidone in Schizophrenia are open now, in 2 countries. Recruiting first, the newest first:
Minerva Neurosciences · Sites in United States
Ages 18–55
Northwell Health · Sites in United States, Canada
Ages 18–35
Louisiana State University Health Sciences Center Shreveport · Sites in United States
Ages 18–65
Centre for Addiction and Mental Health · Sites in Canada
Ages 18+
By country, each count listing its studies:
Risperidone: first FDA approval 1993 (RISPERDAL), first EMA approval 2022. What it is approved for, and how studies give it, is on its page →
Of the 332 Schizophrenia studies recruiting now, 63 (19%) set no upper age limit and 258 (78%) stop at 75 or younger; 42 take children under 18; 83 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
127 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 15 · Phase 2 7 · Phase 3 34 · Phase 4 63
First in 1996; this study’s year is marked. 5 started in 2013.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 36 is below the median of 71 across 2,945 interventional studies indexed under Schizophrenia.
Median enrollment 100 across the 123 interventional studies. Of the 106 that completed or were terminated, 30 (28%) have results posted.
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63 of 127 have an industry lead sponsor. The 10 most frequent:
Rovi Pharmaceuticals Laboratories is the lead sponsor of 19 studies on the registry; 2 are open to participants now.
Rovi Pharmaceuticals Laboratories has 8 studies filed under Schizophrenia — fewer than ten, so there is no comparison to draw.
2 of the studies testing risperidone in Schizophrenia that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06482554Phase 3Louisiana State University Health Sciences Center ShreveportLumateperone for the Improvement of Apathy in Patients With Psychotic Symptoms. | 2026-12 |
| NCT04478838Centre for Addiction and Mental Health"Extended" (Alternate Day) Antipsychotic Dosing | 2027-09-30 |
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Among the 127 studies testing risperidone in Schizophrenia, from their registry updates:
Nothing recorded among them since 2026-09-25.
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This clinical trial is designed to evaluate different dosages of risperidone ISM, a new long-acting injectable form.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Three different single doses will be evaluated
Drug: Risperidone ISM 50 mg
Three different single doses will be evaluated
Drug: Risperidone ISM 75 mg
Three different single doses will be evaluated
Drug: Risperidone ISM 100 mg
Area under the curve
Time frame: Pre-dose and 18 time points Post-dose will be carried out within a 75 day time frame
The record gives a start of Apr 2013, a primary completion of Feb 2014 and a completion of Feb 2014. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Risperidone
Rovi Pharmaceuticals Laboratories