Study to Evaluate the Efficacy and Safety of Risperidone in Situ Microparticle (ISM)® in Patients With Acute Schizophrenia

PHASE3CompletedINTERVENTIONAL
Enrollment

438

Participants

Timeline

Start Date

June 2, 2017

Primary Completion Date

December 17, 2018

Study Completion Date

December 17, 2018

Conditions
Acute Schizophrenia
Interventions
DRUG

Risperidone ISM 75 mg

Monthly (once every 4 weeks) 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.

DRUG

Placebo of Risperidone ISM

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

Trial Locations (31)

20877

CBH Health LLC, Gaithersburg

21005

N.I. Pyrogov Vinnytsya Natl Medical University, Vinnytsia

29407

Carolina Clinical Triasl Inc, Charleston

30331

Atlanta Center for Medical Research, Atlanta

33016

Galiz Research, Hialeah

33021

Innovative Clinical Research Inc., Hollywood

36013

Maltsev Regional Clinical Psychiatric Ho, Poltava

39232

Precise Research Centers MS, Flowood

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

75080

Pillar Clinical Research LLC, Richardson

75115

InSite Clinical Research, DeSoto

78754

Community Clinical Research Inc., Austin

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

90703

CIMU Bellflower, Cerritos

90813

Apostle Clinical Trials, Long Beach

91945

Synergy Research San Diego, Lemon Grove

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

NCT03160521 - Study to Evaluate the Efficacy and Safety of Risperidone in Situ Microparticle (ISM)® in Patients With Acute Schizophrenia | Biotech Hunter | Biotech Hunter