Clinical trial NCT02109562: Randomized, Double-blind, Placebo Controlled, Multi-center and Tolerability of RBP-7000 in Schizophrenia Patients
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of RBP-7000 as a Treatment in Subjects With Acute Schizophrenia Over 8 Weeks (2 Subcutaneous Doses)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Schizophrenia
Schizophrenic
Schizophrenias
Risperidone
Lead sponsor: Indivior Inc.
Sponsor class: INDUSTRY
First posted: 2014-04-10
Enrollment: 354
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of RBP-7000 compared with placebo in the treatment of patients with schizophrenia.

This will be a double-blind, placebo-controlled, Phase III study with 90 mg and 120 mg doses of RBP-7000 compared with placebo over an 8-week treatment period.


Eligibility criteria: Inclusion Criteria:

* Males and females between the ages of 18 to 55 years, inclusive
* Diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual, Edition 4, text revision (DSM-IV-TR) criteria
* Subjects who are deemed "valid" by the State, Assessability, Face, Ecological, and Rule (SAFER) interview
* Subjects who are otherwise healthy on the basis of their physical examination

Exclusion Criteria:

* Subjects who have an improvement in their total Positive and Negative Syndrome Scale (PANSS) score of 20% or greater between the initial screening visit and the first day of treatment.
* Subjects taking daily oral risperidone at a dose ≥ 6 mg/day
* Subjects who have received a depot antipsychotic within 120 days of screen
* Subjects with treatment resistant schizophrenia, as judged by the investigator, who have been treated with antipsychotics for adequate durations and with adequate dosages.

Primary outcomes:
measure: Mixed Model for Repeated Measures (MMRM) Analysis of Change From Baseline to End of Treatment in the Positive and Negative Syndrome Scale (PANSS) Total Score
timeFrame: Day 1 prior to treatment (Baseline), Days 15, 29, 43 and 57 or early discontinuation
Secondary outcomes:
measure: Mixed Model for Repeated Measures (MMRM) Analysis of Change From Baseline to End of Treatment in Clinical Global Impression - Severity Scale (CGI-S)
timeFrame: Day 1 prior to treatment (Baseline), Days 15, 29, 43 and 57 or early discontinuation
measure: Summary of Participants With Treatment-Emergent Adverse Events (TEAE)
timeFrame: Day 1 to Week 8
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Woodland International Research Group, Inc.
state: Arkansas
city: Springdale
country: United States
facility: Woodland International Research Group, Inc.
state: Arkansas
city: Cerritos
country: United States
facility: Comprehensive Clinical Development - Cerritos, CA
state: California
city: Escondido
country: United States
facility: Synergy Clinical Research of Escondido
state: California
city: Glendale
country: United States
facility: Behavioral Research Specialists, LLC
state: California
city: Long Beach
country: United States
facility: Collaborative Neuroscience Networks, Inc.
state: California
city: Long Beach
country: United States
facility: Apostle Clinical Trials, Inc.
state: California
city: Oakland
country: United States
facility: Pacific Research Partners
state: California
city: Oceanside
country: United States
facility: Excell Research, Inc.
state: California
city: Pico Rivera
country: United States
facility: CNRI- Los Angeles, LLC
state: California
city: San Diego
country: United States
facility: CNRI - San Diego, LLC
state: California
city: Fort Lauderdale
country: United States
facility: Innovative Clinical Research
state: Florida
city: North Miami
country: United States
facility: Behavioral Clinical Research, Inc.
state: Florida
city: Orlando
country: United States
facility: Florida Clinical Research Center, LLC
state: Florida
city: Chicago
country: United States
facility: Uptown Research Institute
state: Illinois
city: Hoffman Estates
country: United States
facility: Alexian Brothers Behavioral Health Hospital
state: Illinois
city: Wichita
country: United States
facility: Via Christi Research
state: Kansas
city: Lake Charles
country: United States
facility: Lake Charles Clinical Trials, LLC
state: Louisiana
city: Shreveport
country: United States
facility: J. Gary Booker, MD, APMC
state: Louisiana
city: Saint Louis
country: United States
facility: St. Louis Clinical Trials
state: Missouri
city: Saint Louis
country: United States
facility: PsychCare Consultants Research
state: Missouri
city: Las Vegas
country: United States
facility: Altea Research Institute
state: Nevada
city: Marlton
country: United States
facility: CRI Lifetree
state: New Jersey
city: Cedarhurst
country: United States
facility: Neurobehavioral Research, Inc.
state: New York
city: Charlotte
country: United States
facility: New Hope Clinical Research
state: North Carolina
city: Dayton
country: United States
facility: Midwest Clinical Research Center, LLC
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Clinical Research Center
state: Oklahoma
city: Philadelphia
country: United States
facility: CRI Lifetree
state: Pennsylvania
city: Austin
country: United States
facility: FutureSearch Clinical Trials, L.P.
state: Texas
city: Austin
country: United States
facility: Community Clinical Research, Inc.
state: Texas
city: Dallas
country: United States
facility: FutureSearch Clinical Trials, L.P.
state: Texas
city: Dallas
country: United States
facility: Pillar Clinic Research, LLC
state: Texas
Study officials:
affiliation: Indivior Inc.
name: Global Clinical Developoment Manager
role: STUDY_DIRECTOR
References:
citation: Andrade C. Prazosin for Alcohol Use Disorder: Reply to Sinha. J Clin Psychiatry. 2021 Sep 21;82(6):21lr14076a. doi: 10.4088/JCP.21lr14076a. No abstract available.
citation: Sinha R. Prazosin for Alcohol Use Disorder: A Clarification. J Clin Psychiatry. 2021 Sep 21;82(6):21lr14076. doi: 10.4088/JCP.21lr14076. No abstract available.
citation: Le Moigne A, Csernansky J, Leadbetter RA, Andorn AC, Graham JA, Heath AT, Walling DP, Newcomer JW, Marder SR. PANSS Individual Item and Marder Dimension Analyses From a Pivotal Trial of RBP-7000 (Monthly Extended-Release Risperidone) in Schizophrenia Patients. J Clin Psychiatry. 2021 Sep 21;82(5):21m13906. doi: 10.4088/JCP.21m13906.