Study to Evaluate the Efficacy and Safety of Risperidone ISM® in Patients With Acute Schizophrenia: Open Label Extension
Completed · Phase 3
Conditions studied: Schizophrenia
In brief
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.
Key facts
- Study ID
- NCT03870880
- Run by
- Rovi Pharmaceuticals Laboratories
- People needed
- 215
- Starts
- 2017-08-25
- Expected to finish
- 2020-01-08
- Last updated by the study team
- 2022-03-25
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Woodland Research Northwest — Rogers, Arkansas, United States
- Collaborative Neuroscience Network, LLC. — Garden Grove, California, United States
- Apostle Clinical Trials Inc. — Long Beach, California, United States
- NRC Research Institute — Orange, California, United States
- CNRI-Los Angeles LLC — Pico Rivera, California, United States
- CNRI-San Diego — San Diego, California, United States
- Galiz Research — Hialeah, Florida, United States
- Innovative Clinical Research Inc. — Hollywood, Florida, United States
- CBH Health LLC — Gaithersburg, Maryland, United States
- Altea Research Institute — Las Vegas, Nevada, United States
- Hassman Research Institute — Berlin, New Jersey, United States
- Midwest Clinical Research Center — Dayton, Ohio, United States
- InSite Clinical Research — DeSoto, Texas, United States
- Regional Clinical Hospital n.a I.I. Mechnicov — Dnipro, Ukraine
- Kharkiv Regional Clinical Psychiatric Hospital — Kharkiv, Ukraine
- Public Healthcare Institution "Kharkiv Regional Clinical Psychiatric Hospital No. 3", Center of Urgent Psychiatry — Kharkiv, Ukraine
- Kherson Regional Psychiatric Hospital — Kherson, Ukraine
- Kiev City Psychiatric Hospital No. 2 — Kiev, Ukraine
- Kyiv Regional Medical Association "Psykhiatriya" in Kyiv — Kiev, Ukraine
- CI Lviv Regional Clinical Psychiatric Hospital. Department 20 — Lviv, Ukraine
- CI Lviv Regional Clinical Psychiatric Hospital. Department 25 — Lviv, Ukraine
- Odesa Regional Medical Centre of Mental Health — Odesa, Ukraine
- Maltsev Regional Clinical Psychiatric Ho — Poltava, Ukraine
- N.I. Pyrogov Vinnytsya Natl Medical University — Vinnytsia, Ukraine
Full record on ClinicalTrials.gov
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