Schizophrenia
Conditions
Keywords
risperidone, schizophrenia, long-acting injectable
Brief summary
This is an Open-Label, One-Sequence Study to Evaluate the Steady- State Comparative Bioavailability of Intramuscular Risperidone ISM® and EU Risperdal® (Sourced From Germany).
Detailed description
This was an open-label, 1-sequence study in patients who are were stable oral risperidone treatment. The study consisted of a screening visit, 1 treatment period with inpatient and outpatient visits, and a Follow-up visit. Patients who were receiving existing oral risperidone treatment (4 mg) continued the oral regimen for 1 week to achieve steady-state concentrations of risperidone (Treatment A). Following the oral risperidone treatment, a single IM dose of 100 mg Risperidone ISM® was administered deeply into the gluteal muscle. A total of 4 IM doses were given, each dose separated by 4 weeks (Treatment B). Safety assessments and PK sampling were performed once each dosing day and each outpatient visit. A final Follow-up visit was conducted to assess each patient for safety and to obtain PK samples. Approximately 80 (with no screening failure) patients were planned for enrolment, with the intent to complete 48 patients with the assumption of an approximate drop-out/not valuable PK rate of 40%. The primary objective of this study was to evaluate the steady-state comparative bioavailability of 100 mg Risperidone ISM® injectable every 4 weeks compared to once-daily 4 mg oral risperidone in patients with schizophrenia stabilized on oral risperidone treatment. The secondary objective of this study was to evaluate the safety and tolerability of 100 mg Risperidone ISM® injectable every 4 weeks compared to once-daily 4 mg oral risperidone in patients with schizophrenia stabilized on oral risperidone treatment.
Interventions
100 mg of risperidone ISM® administered every 4 weeks
DRUGRisperdal 4mg Tablet
4 mg oral risperidone once daily for 7 days
Sponsors
Rovi Pharmaceuticals Laboratories
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is an open-label, 1-sequence study to Evaluate the Steady- State Comparative Bioavailability of Intramuscular Risperidone ISM® and EU Risperdal® (Sourced From Germany) in subjects with schizophrenia who are on stable oral risperidone treatment. The study consists of a screening visit, 1 treatment period with inpatient and outpatient visits, and a follow-up visit.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Subjects will be considered eligible to participate in this study if each one of the following inclusion criteria is satisfied at screening (or at baseline when specified): 1. Male or female aged ≥18 and \<65 years with a body mass index (BMI) of ≥17 kg/m2 but ≤35 kg/m2 2. Current diagnosis of schizophrenia, according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria 3. Outpatient; not hospitalized for worsening of schizophrenia within the last 3 months (hospitalization for social management within this time period is acceptable) 4. Medically stable over the last month and psychiatrically stable without significant symptom exacerbation over the last 3 months based on the investigator's judgement 5. On oral risperidone 4 mg daily as maintenance therapy for at least the last 4 weeks prior to screening and on 4 mg oral risperidone once daily QD for at least one week prior baseline (Day1, Visit 2) 6. Agrees to taper off all prohibited medications prior to baseline 7. On a stable dosage of all permitted medications (with the exception of medication to be used on an as-needed basis) for at least 2 weeks prior to the baseline visit and for the duration of the study 8. Clinical Global Impression - Severity (CGI-S) score of ≤4 (moderately ill) 9. A female subject of childbearing potential who is sexually active and using a medically accepted contraceptive method. Acceptable methods include condoms (male or female) with or without spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed intrauterine device, and hormonal contraceptives. A female subject of childbearing potential who is not currently sexually active must agree that should she be so while participating in the trial, she will use a medically accepted method of contraception for the remainder of the study and for 1 month afterward. Female patients who have had a hysterectomy, bilateral tubal ligation, or bilateral salpingooophorectomy are considered surgically sterile and are thus are exempt from the requirement to use contraception. Female patients who are postmenopausal are considered not of childbearing potential and thus exempt from the contraception requirement; for the purpose of this study, postmenopausal is defined as the permanent cessation of menstruation for at least 12 months prior to screening in women ≥ 45 years of age. 10. Female subjects must have a negative pregnancy test at screening (serum test) and baseline (urine test) 11. Psychotherapy should not be started or changed during a patient's participation in the study. It is acceptable for a patient already receiving psychotherapy to participate in the study 12. Able to speak, read, and understand sufficiently to allow completion of all study assessments 13. Must provide written informed consent prior to the initiation of any protocol-specific procedures
Exclusion criteria
Subjects will not be considered eligible to participate in this study if any one of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the curve during the dosing interval (AUCtau) | 28-day period following administration of the fourth dose of risperidone ISM® | Mean steady-state area under the curve during the dosing interval for the active moiety |
Countries
United States
Outcome results
None listed