Schizophrenia Clinical Trial
Official title:
An Open-Label, Long-Term Safety and Tolerability Study of RBP-7000 in the Treatment of Subjects With Schizophrenia
Verified date | August 2018 |
Source | Indivior Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a Phase 3, open label study administering RBP-7000 in the treatment of patients with schizophrenia. Study will assess the long-term safety and tolerability of RBP-7000 subcutaneous (SC) injections in subjects with schizophrenia and to continue collecting clinical outcome data with RBP-7000 SC injections in subjects with schizophrenia using the Positive and Negative Syndrome Scale (PANSS) and Clinical Global Impression-Severity Illness (CGI-S) scale.
Status | Completed |
Enrollment | 500 |
Est. completion date | September 2016 |
Est. primary completion date | September 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Radiant Research | Atlanta | Georgia |
United States | Community Clinical Research, Inc. | Austin | Texas |
United States | FutureSearch Clinical Trials | Austin | Texas |
United States | Florida Clinical Research Center | Bradenton | Florida |
United States | Behavioral Medical Research of Brooklyn | Brooklyn | New York |
United States | Neurobehavioral Research | Cedarhurst | New York |
United States | Comprehensive Clinical Development | Cerritos | California |
United States | New Hope Clinical Research | Charlotte | North Carolina |
United States | Uptown Research Institute | Chicago | Illinois |
United States | FutureSearch Clinical Trials, L.P. | Dallas | Texas |
United States | Pillar Clinical Research | Dallas | Texas |
United States | iResearch Atlanta | Decatur | Georgia |
United States | Synergy EPIC | Escondido | California |
United States | Innovative Clinical Research | Fort Lauderdale | Florida |
United States | Behavioral Research Specialists | Glendale | California |
United States | Clinical Trials of America | Hickory | North Carolina |
United States | Behavioral Health Hospital | Hoffman Estates | Illinois |
United States | Behavioral Clinical Reserach | Hollywood | Florida |
United States | Bayou City Research | Houston | Texas |
United States | Comprehensive Clinical Development-Queens | Jamaica | New York |
United States | Lake Charles Clinical Trials | Lake Charles | Louisiana |
United States | Altea Research Institute | Las Vegas | Nevada |
United States | Woodland International Research Group, Inc. | Little Rock | Arkansas |
United States | Apostle Clinical Trials | Long Beach | California |
United States | Collaborative Neuroscience Network, LLC | Long Beach | California |
United States | Florida Clinical Research Center | Maitland | Florida |
United States | CRI Lifetree - Marlton Unit | Marlton | New Jersey |
United States | Research Strategies of Memphis | Memphis | Tennessee |
United States | Premier Clinical Resarch Institute | Miami | Florida |
United States | Baber Research Group | Naperville | Illinois |
United States | Keystone Clinical Studies | Norristown | Pennsylvania |
United States | Research Center for Clinical Studies | Norwalk | Connecticut |
United States | Pacific Research Partners | Oakland | California |
United States | Excell Research | Oceanside | California |
United States | Cutting Edge Research Group | Oklahoma City | Oklahoma |
United States | Oklahoma Clinical Research Center | Oklahoma City | Oklahoma |
United States | CRI Lifetree - Philadelphia Unit | Philadelphia | Pennsylvania |
United States | CNRI-Los Angeles | Pico Rivera | California |
United States | Berks Center for ClinicalResearch | Reading | Pennsylvania |
United States | Alliance Research Group | Richmond | Virginia |
United States | Finger Lakes Clinical Research | Rochester | New York |
United States | Centerpointe Hospital | Saint Charles | Missouri |
United States | St. Louis Clinical Trials | Saint Louis | Missouri |
United States | CNRI-San Diego | San Diego | California |
United States | Insight Clinical Trials LLC | Shaker Heights | Ohio |
United States | Woodland Research Northwest, LLC | Springdale | Arkansas |
United States | Comprehensive Clinical Development-Washington DC | Washington | District of Columbia |
United States | Via Christi Research | Wichita | Kansas |
Lead Sponsor | Collaborator |
---|---|
Indivior Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Participants With Treatment-Emergent Adverse Events (TEAE) | An adverse event (AE) is defined as any study-related event that represents a change (positive or negative) in frequency or severity from a baseline (prestudy) event (if any), regardless of the presence of causal relationship or medical significance. Treatment-emergent adverse events are defined as any adverse event with a start date on or after the first study dose date. AEs are determined by the Investigator to be related or not related to the study drug. A serious AE (SAE) is defined by federal regulation as any AE occurring at any dose that results in any of the following outcomes: death, life-threatening AE, hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Although a subject may have had 2 or more adverse experiences the subject is counted only once in a category. The same subject may appear in different categories. |
Day 1 up to week 52 | |
Primary | Participants With Injection Site-Related Treatment-Emergent Adverse Events (TEAEs) | An adverse event (AE) is defined as any study-related event that represents a change (positive or negative) in frequency or severity from a baseline (prestudy) event (if any), regardless of the presence of causal relationship or medical significance. Treatment-emergent adverse events are defined as any adverse event with a start date on or after the first study dose date. Adverse events were coded using MedDRA version 17.0. Preferred terms linked to injection site AEs are reported. Although a participant may have had 2 or more AEs, the subject is counted only once in each preferred term category. The same subject may appear in different preferred term categories. |
Day 1 up to week 52 | |
Primary | Participants With Markedly Abnormal Weight Gain Anytime During the Study as Compared to Baseline | Participants who were found to have gain >=7% and >=10% of their baseline weight at any point during the study (including unscheduled assessments) once treatment began. | Baseline (Day 0), Treatment (Day 1 up to Week 52) | |
Secondary | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score to Days 29, 169 and End of Study | The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor judgement, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score is the sum of all 30 PANSS items and ranges from 30 to 210, with 30 indicating absence of symptoms of schizophrenia and 210 indicating extreme ratings of all 30 symptoms. Negative change from baseline scores indicate improvements in symptoms. | Baseline (Day 0), Day 29, Day 169 and End of Study (approximately Week 52) | |
Secondary | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Subscale Scores to End of Study | PANSS subscales: Positive scale assesses 7 items: delusions, conceptual disorganization, hallucinations, excitement, grandiosity, suspiciousness/persecution, and hostility. Scale: 7 (absent) to 49 (extreme psychopathology) Negative scale assesses 7 items: blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Scale: 7 (absent) to 49 (extreme psychopathology) General Psychopathology scale assesses 16 items: somatic concern, anxiety, guilt feelings, tension, mannerisms and posturing, depression, motor retardation, uncooperativeness, unusual thought content, disorientation, poor attention, lack of judgment and insight, disturbance of volition, poor impulse control, preoccupation, and active social avoidance. Scale: 16 (absent) to 112 (extreme psychopathology) Negative change from baseline scores indicate improvements. |
Baseline (Day 0), End of Study (approximately Week 52) | |
Secondary | Change From Baseline in Clinical Global Impression - Severity Scores (CGI-S) to Days 29, 169 and End of Study | The CGI-S rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Negative change from baseline scores indicate improvement in the severity of illness. | Baseline (Day 0), Baseline (Day 0), Day 29, Day 169 and End of Study (approximately Week 52) |
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