Long Term Study of RBP 7000 in the Treatment of Subjects With Schizophrenia

PHASE3CompletedINTERVENTIONAL
Enrollment

500

Participants

Timeline

Start Date

June 30, 2014

Primary Completion Date

September 30, 2016

Study Completion Date

September 30, 2016

Conditions
Schizophrenia
Interventions
DRUG

RBP-7000

"120-mg RBP-7000 dose delivered by subcutaneous injection every 28 days for a total of 13 injections (for roll-over participants, the first two injections took place under study RB-US-09-0010).~A one-time down-titration to 90 mg RBP-7000 is permitted at the investigator's discretion should the participant have tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator.~RBP-7000 is a combination of the ATRIGEL Delivery System and risperidone. The ATRIGEL Delivery System allows for sustained-release of risperidone in a controlled manner."

Trial Locations (48)

11241

Behavioral Medical Research of Brooklyn, Brooklyn

11432

Comprehensive Clinical Development-Queens, Jamaica

11516

Neurobehavioral Research, Cedarhurst

14618

Finger Lakes Clinical Research, Rochester

19139

CRI Lifetree - Philadelphia Unit, Philadelphia

19403

Keystone Clinical Studies, Norristown

19604

Berks Center for ClinicalResearch, Reading

20016

Comprehensive Clinical Development-Washington DC, Washington D.C.

23230

Alliance Research Group, Richmond

28204

New Hope Clinical Research, Charlotte

28601

Clinical Trials of America, Hickory

30030

iResearch Atlanta, Decatur

30328

Radiant Research, Atlanta

32751

Florida Clinical Research Center, Maitland

33021

Behavioral Clinical Reserach, Hollywood

33122

Premier Clinical Resarch Institute, Miami

33308

Innovative Clinical Research, Fort Lauderdale

34201

Florida Clinical Research Center, Bradenton

38119

Research Strategies of Memphis, Memphis

44122

Insight Clinical Trials LLC, Shaker Heights

60169

Behavioral Health Hospital, Hoffman Estates

60563

Baber Research Group, Naperville

60640

Uptown Research Institute, Chicago

63118

St. Louis Clinical Trials, St Louis

63304

Centerpointe Hospital, Saint Charles

67214

Via Christi Research, Wichita

70629

Lake Charles Clinical Trials, Lake Charles

72211

Woodland International Research Group, Inc., Little Rock

72764

Woodland Research Northwest, LLC, Springdale

73112

Oklahoma Clinical Research Center, Oklahoma City

73116

Cutting Edge Research Group, Oklahoma City

75231

FutureSearch Clinical Trials, L.P., Dallas

75243

Pillar Clinical Research, Dallas

77007

Bayou City Research, Houston

78731

FutureSearch Clinical Trials, Austin

78754

Community Clinical Research, Inc., Austin

89102

Altea Research Institute, Las Vegas

90660

CNRI-Los Angeles, Pico Rivera

90703

Comprehensive Clinical Development, Cerritos

90806

Collaborative Neuroscience Network, LLC, Long Beach

90813

Apostle Clinical Trials, Long Beach

91206

Behavioral Research Specialists, Glendale

92025

Synergy EPIC, Escondido

92056

Excell Research, Oceanside

92102

CNRI-San Diego, San Diego

94612

Pacific Research Partners, Oakland

06851

Research Center for Clinical Studies, Norwalk

08053-3426

CRI Lifetree - Marlton Unit, Marlton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Indivior Inc.

INDUSTRY

NCT02203838 - Long Term Study of RBP 7000 in the Treatment of Subjects With Schizophrenia | Biotech Hunter | Biotech Hunter