Long Term Study of RBP 7000 in the Treatment of Subjects With Schizophrenia
Schizophrenia
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Schizophrenic, Schizophrenias, Risperidone, Long-acting Risperidone, Atrigel, Subcutaneous
Eligibility Criteria
Inclusion Criteria:
"De Novo" Patients
- Diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual, Edition 4, text revision (DSM-IV-TR) criteria
- Total PANSS score <=70 at the time of screening (Visit 1)
- Otherwise healthy on the basis of physical examinatIon
- Provided written informed consent
"Roll-over Patients
- Provided written consent to participate in this study
- Be considered eligible to enroll based on End of Study (EOS) (Day 57 of Study RB-US-09-0010) assessments and the medical judgment of the investigator
Exclusion Criteria:
"De Novo" Patients
- Patients taking daily oral risperidone at a dose plus/minus 6 mg/day
- Patients taking any risperidone or 9-hydroxyrisperidone long-acting injectable formulation within 120 days of study screening (Visit 1)
- Patients who have received a long-acting injectable antipsychotic within 120 days of screening (Visit 1)
Patients with evidence or history (in the past six months prior to screening) of a significant hepatic disorder that may either compromise patient safety or interfere with the safety and/or outcome evaluation of the study drug, including:
- Acute or chronic hepatitis, including but not limited to hepatitis B or C
- Total bilirubin greater than 1.5 times the upper limit of normal (ULN), or
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2 times ULN
- Patients with a history of drug-induced leukopenia
- Patients with other medical conditions including, but not limited to, history of heart attack (myocardial infarction) or brain injury (traumatic injury with loss of consciousness and/or cerebrovascular accident), and clinically significant low blood pressure or arrhythmias as interpreted by the primary investigator (PI) or medically qualified sub-investigator
- Patients with epilepsy or other seizure disorders, Parkinson's disease or dementia
"Roll-over" Patients
- Patients requiring an inpatient treatment setting at the end of Study RB-US-09-0010
- Patients with an unstable medical condition developed during Study RB-US-09-0010
- Women of childbearing potential who have a positive pregnancy test at screening (Visit 1), who are pregnant or breastfeeding, seeking pregnancy, or failing to use adequate contraceptive methods during the study
Sites / Locations
- Woodland International Research Group, Inc.
- Woodland Research Northwest, LLC
- Comprehensive Clinical Development
- Synergy EPIC
- Behavioral Research Specialists
- Collaborative Neuroscience Network, LLC
- Apostle Clinical Trials
- Pacific Research Partners
- Excell Research
- CNRI-Los Angeles
- CNRI-San Diego
- Research Center for Clinical Studies
- Comprehensive Clinical Development-Washington DC
- Florida Clinical Research Center
- Innovative Clinical Research
- Behavioral Clinical Reserach
- Florida Clinical Research Center
- Premier Clinical Resarch Institute
- Radiant Research
- iResearch Atlanta
- Uptown Research Institute
- Behavioral Health Hospital
- Baber Research Group
- Via Christi Research
- Lake Charles Clinical Trials
- Centerpointe Hospital
- St. Louis Clinical Trials
- Altea Research Institute
- CRI Lifetree - Marlton Unit
- Behavioral Medical Research of Brooklyn
- Neurobehavioral Research
- Comprehensive Clinical Development-Queens
- Finger Lakes Clinical Research
- New Hope Clinical Research
- Clinical Trials of America
- Insight Clinical Trials LLC
- Oklahoma Clinical Research Center
- Cutting Edge Research Group
- Keystone Clinical Studies
- CRI Lifetree - Philadelphia Unit
- Berks Center for ClinicalResearch
- Research Strategies of Memphis
- FutureSearch Clinical Trials
- Community Clinical Research, Inc.
- FutureSearch Clinical Trials, L.P.
- Pillar Clinical Research
- Bayou City Research
- Alliance Research Group
Arms of the Study
Arm 1
Experimental
RBP-7000 - 120-mg dose
RBP-7000 120-mg subcutaneous (SC) injections every 28 days for 13 doses as open-label therapy. Patients enter the study as 'roll-over' patients from study RB-US-09-0010, or de novo patients. Pre-study procedures vary for de novo patients depending on previous therapy.