Study to Evaluate the Efficacy and Safety of Risperidone ISM® in Patients With Acute Schizophrenia: Open Label Extension
Public ClinicalTrials.gov record NCT03870880. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03870880
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 215 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 25, 2017 (Actual)
- Primary completion
- Jan 8, 2020 (Actual)
- Completion
- Jan 8, 2020 (Actual)
- Last update posted
- Mar 25, 2022
2017 – 2020
United States locations
- U.S. sites
- 13
- U.S. states
- 8
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Woodland Research Northwest | Rogers | Arkansas | 72758 | — |
| Collaborative Neuroscience Network, LLC. | Garden Grove | California | 92845 | — |
| Apostle Clinical Trials Inc. | Long Beach | California | 90813 | — |
| NRC Research Institute | Orange | California | 92868 | — |
| CNRI-Los Angeles LLC | Pico Rivera | California | 90660 | — |
| CNRI-San Diego | San Diego | California | 92112 | — |
| Galiz Research | Hialeah | Florida | 33016 | — |
| Innovative Clinical Research Inc. | Hollywood | Florida | 33021 | — |
| CBH Health LLC | Gaithersburg | Maryland | 20877 | — |
| Altea Research Institute | Las Vegas | Nevada | 89102 | — |
| Hassman Research Institute | Berlin | New Jersey | 08009 | — |
| Midwest Clinical Research Center | Dayton | Ohio | 45417 | — |
| InSite Clinical Research | DeSoto | Texas | 75115 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 11 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03870880, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 25, 2022 · Synced Nov 1, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03870880 live on ClinicalTrials.gov.