Study to Evaluate the Efficacy and Safety of Risperidone ISM® in Patients With Acute Schizophrenia: Open Label Extension

PHASE3CompletedINTERVENTIONAL
Enrollment

215

Participants

Timeline

Start Date

August 25, 2017

Primary Completion Date

January 8, 2020

Study Completion Date

January 8, 2020

Conditions
Schizophrenia
Interventions
DRUG

Risperidone ISM 75 mg

Monthly (once every 4 weeks) intramuscular (IM) injection in the gluteal or deltoid muscle.

DRUG

Risperidone ISM 100 mg

Monthly (once every 4 weeks) IM injection in the gluteal or deltoid muscle.

Trial Locations (24)

20877

CBH Health LLC, Gaithersburg

21005

N.I. Pyrogov Vinnytsya Natl Medical University, Vinnytsia

33016

Galiz Research, Hialeah

33021

Innovative Clinical Research Inc., Hollywood

36013

Maltsev Regional Clinical Psychiatric Ho, Poltava

45417

Midwest Clinical Research Center, Dayton

49005

Regional Clinical Hospital n.a I.I. Mechnicov, Dnipro

61068

Kharkiv Regional Clinical Psychiatric Hospital, Kharkiv

"Public Healthcare Institution Kharkiv Regional Clinical Psychiatric Hospital No. 3, Center of Urgent Psychiatry", Kharkiv

65006

Odesa Regional Medical Centre of Mental Health, Odesa

72758

Woodland Research Northwest, Rogers

73488

Kherson Regional Psychiatric Hospital, Kherson

75115

InSite Clinical Research, DeSoto

79021

CI Lviv Regional Clinical Psychiatric Hospital. Department 20, Lviv

CI Lviv Regional Clinical Psychiatric Hospital. Department 25, Lviv

89102

Altea Research Institute, Las Vegas

90660

CNRI-Los Angeles LLC, Pico Rivera

90813

Apostle Clinical Trials Inc., Long Beach

92112

CNRI-San Diego, San Diego

92845

Collaborative Neuroscience Network, LLC., Garden Grove

92868

NRC Research Institute, Orange

08009

Hassman Research Institute, Berlin

02192

Kiev City Psychiatric Hospital No. 2, Kiev

04080

"Kyiv Regional Medical Association Psykhiatriya in Kyiv", Kiev

All Listed Sponsors
lead

Rovi Pharmaceuticals Laboratories

INDUSTRY

NCT03870880 - Study to Evaluate the Efficacy and Safety of Risperidone ISM® in Patients With Acute Schizophrenia: Open Label Extension | Biotech Hunter | Biotech Hunter