An observational study in Schizophrenia, sponsored by Rovi Pharmaceuticals Laboratories. Completed at 77 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-05.
Sponsored by Rovi Pharmaceuticals Laboratories · Observational
Among 156 studies in Schizophrenia with a site in Spain — 12 open to participants now, 14 under way, 2 of them phase 3. Schizophrenia · Spain.
Among the 156 studies in Schizophrenia with a site in Spain, this one is the 11th largest by enrollment of the 32 observational ones that give a count, is one of 4 that started in 2022, is one of 32 observational ones, and was the 136th registered.
3,565 studies on the registry are indexed under Schizophrenia; 492 are open to participants now.
Browse Schizophrenia studies →12 of the 156 studies in Schizophrenia with a site in Spain are open now. Recruiting first, the newest first:
Karuna Therapeutics, Inc., a Bristol Myers Squibb company · Sites in Spain, United States, Argentina and 4 more countries
Ages 18–65
University of the Basque Country (UPV/EHU) · Sites in Spain
Ages 18–65
Karuna Therapeutics, Inc., a Bristol Myers Squibb company · Sites in Spain, United States, Australia and 8 more countries
Ages 5–17
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Sites in Spain
Ages 18+
Dr. Inge Winter · Sites in Spain, Austria, Germany and 2 more countries
Ages 18–70
A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →
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 and older · all sexes · no healthy volunteers.
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156 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 10 · Phase 2 14 · Phase 3 39 · Phase 4 20
First in 2001; this study’s year is marked. 4 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 275 is above the median of 178 across 507 observational studies indexed under Schizophrenia.
Median enrollment 200 across the 123 interventional studies, 200 across the 32 observational. Of the 121 that completed or were terminated, 36 (30%) have results posted.
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81 of 156 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.
1 of the studies in Schizophrenia with a site in Spain that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07921667International University of La RiojaSleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment | 2027-08 |
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Among the 156 studies in Schizophrenia with a site in Spain, from their registry updates:
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This is a prospective, non-interventional, multicentre study designed to collect information about the effectiveness, safety and tolerability of Risperidone ISM in patients diagnosed with schizophrenia who are suffering an acute exacerbation, according to routine clinical practice.
This is a non-interventional, multicentre, prospective study conducted in psychiatric inpatient units, and designed to collect information about the effectiveness, safety and tolerability of Risperidone ISM in patients diagnosed with schizophrenia and who are suffering an acute exacerbation, according to routine clinical practice.
The study comprises five visits in total:
Baseline Visit: This visit must be conducted within 48 hours after the first injection of Risperidone ISM. During this visit, the patient must meet all inclusion and exclusion criteria and sign the Informed Consent Form.
Follow-up Visit I: Scheduled approximately 8 ± 2 days after the first injection.
Follow-up Visit II: Scheduled approximately 28 ± 2 days after the first injection.
Discharge Visit: Conducted on the day of discharge, which may vary depending on the individual patient.
Final Visit: Occurs approximately 28 days after the second injection of Risperidone ISM and may be conducted in person or via telephone.
The study will be conducted in five visits: the Baseline Visit is the day on which the patient fulfils the inclusion and exclusion criteria, including signature of the Informed Consent; two follow-up visits will be scheduled after the first injection of Risperidone ISM; in addition, there will be another visit on the day of discharge; and the Final Visit will occur approximately 28 days after the 2nd injection of Risperidone ISM.
The primary objective of the study is to assess, under usual clinical practice, the effectiveness of Risperidone ISM in patients hospitalised due to a schizophrenia relapse.
The secondary objectives include:
Analysis of patterns of use of Risperidone ISM in hospital settings across several European countries.
Characterisation of patient profiles treated with Risperidone ISM in routine clinical practice.
Assessment of social functioning in schizophrenia patients treated with Risperidone ISM.
Evaluation of duration of hospitalisation across participating countries. Measurement of patient-reported treatment satisfaction. Evaluation of safety and tolerability of Risperidone ISM in routine clinical practice.
To assess these objectives, the following scales will be used:
PANSS-6: Baseline visit, Follow-up Visit I, Follow-up Visit II, and Final Visit.
CGI-S: Baseline visit, Follow-up Visit I, Follow-up Visit II, and Final Visit. PSP: Baseline visit, Follow-up Visit II, and Final Visit. MSQ: Baseline visit, Follow-up Visit II, and Final Visit.
Approximately 1,200 adults' patients were calculated to be enrolled in the sites from the participating countries.
The initial sample size estimation relied on an extremely small effect size that would be very unlikely given the results on a previous clinical trial with Risperidone ISM. After the examination of preliminary trial data and considering that the recruitment period was going to be longer than expected (mostly related to administrative issues for activating sites), the Sponsor has decided to re-evaluate the sample size required for the study. For this new estimation, the objective was to calculate the sample size that would allow to perform the analyses of the primary effectiveness variables not only in the total study population, but also in the subgroups who were pre-specified in the study protocol. Accordingly, the estimation was adjusted for each of the subgroups estimated share of the total study sample, and then accounted for the expected loss of patients, that was adjusted upwards to 35%. After that, the new sample size was set at approximately 272 patients.
Patients aged 18 diagnosed with schizophrenia who are admitted to a psychiatric unit due to a relapse and initiate treatment with Risperidone ISM (OKEDI®), according to the therapeutic indication of the marketing authorization ("Treatment of schizophrenia in adults for whom tolerability and effectiveness has been established with oral risperidone") under routine clinical practice.
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Risperidone ISM is administered every 4 weeks
Also known as: OKEDI®
Clinical Global Impression-Severity of Illness scale (CGI-S): change from baseline to Day 56.
The Clinician Global Impression - Severity (CGI-S) score is a 7-point clinician-rated scale for assessing the global severity of the illness. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Negative change from baseline scores indicate improvement in the severity of illness whereas higher scores mean a worse outcome.
Time frame: Baseline and Day 56 (or the last post-baseline assessment)
Positive and Negative Syndrome Scale (PANSS-6): change from baseline to Day 56.
The six-item version of the Positive and Negative Syndrome Scale (PANSS-6) is a 6-item scale derived from the full 30-item PANSS which evaluate: Delusions, Conceptual disorganization, Hallucinations, Blunted Affect, Social withdrawal and Lack of spontaneity and flow of conversation Safety and tolerability.
Time frame: Baseline and Day 56 (or the last post-baseline assessment)
Personal and Social Performance (PSP) scale
The PSP is a 100-point single-item rating scale that is based on 4 areas: personal and social relationships; self-care; work and socially useful activities, and disturbing and aggressive behaviors. Each of the 4 domains is rated in 6 degrees of severity (absent, mild, manifest, marked, severe, very severe). Higher PSP scores indicate a better social functioning.
Time frame: Baseline and Day 56 (or the last post-baseline assessment)
Medication Satisfaction Questionnaire (MSQ)
The Medication Satisfaction Questionnaire (MSQ) is a single-item, global, patient-completed instrument designed to assess treatment satisfaction among patients with schizophrenia. It consists of 1 question: "Overall, how satisfied are you with your current antipsychotic medication(s)?" with responses assessed on a 7-point scale rated as follows: 1 = extremely dissatisfied, 2 = very dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = very satisfied, 7 = extremely satisfied.
Time frame: Day 56 (or the last post-baseline assessment)
Duration of hospitalisation
The duration of hospitalisation is the time from admission in the hospital to discharge.
Time frame: Baseline and Day 56 (or the last post-baseline assessment)
Adverse drug reactions (ADR)
An adverse drug reaction (ADR), is a response to a study treatment that is noxious and unintended and that occurs at doses normally used in man for prophylaxis, diagnosis or therapy of disease, or for the restoration, correction, or modification of physiological functions. Response in this context means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility.
Time frame: Up to Day 56 (or the last post-baseline assessment)
Ran from Oct 2022 to primary completion in Mar 2025, 28 months.
Of 136 observational studies under Schizophrenia, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 102. This study's 28 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Rovi Pharmaceuticals Laboratories