Schizo-affective Disorder, Schizophrenia
Conditions
Brief summary
The study will be a 6-month, open-label, multiple center study in approximately 50 stable subjects diagnosed with schizophrenia or schizoaffective disorder to evaluate the safety, tolerability, and pharmacokinetics of Risperidone and 9-OH-Risperidone following implantation of two or three, 300 mg Risperidone Implants.
Detailed description
The study will be a 6-month, open-label, study in approximately 50 stable subjects diagnosed with schizophrenia or schizoaffective disorder to evaluate the safety, tolerability, and pharmacokinetics of Risperidone and 9-OH-Risperidone following implantation of two or three, 300 mg Risperidone Implants. Subjects who are diagnosed with schizophrenia or schizoaffective disorder according to DSM-V and are stable on a daily 4 mg oral dose of Risperidone for at least 8 weeks will be recruited into the study. Subjects stable on a 4 mg oral dose of Risperidone will be implanted with two or three, 300 mg, Risperidone Implants. All implants will be placed in the inner aspect of the upper arm. Plasma concentrations of Risperidone and the active moiety will be measured prior to placement of the Risperidone Implants, throughout the implantation period, and after re-converting to oral Risperidone following the removal of the Risperidone Implants.
Interventions
Sponsors
Braeburn Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Subject (and/or a subject's authorized legal representative) has provided written informed consent 2. Patient meets the following criteria: * Outpatient status * PANSS Total Score ≤ 80 at screening and if PANSS score at baseline is ≥ 20% change from screening, the patients cannot participate in the study. * A score of ≤ 3 on the following PANSS items: * Conceptual disorganization * Suspiciousness * Hallucinatory behavior * Unusual thought content 3. Subject is male or female between 18 to 60 years of age 4. Subject has a diagnosis of schizophrenia or schizoaffective disorder according to Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V) criteria
Exclusion criteria
1. Hospitalized or required acute crisis intervention for symptom exacerbation in the 60 days prior to admission as determined by the Investigator 2. Subject has a history of suicide attempt in the last year, or in the opinion of the investigator is currently at imminent risk of suicide 3. Has a current or recent (within 12 months) DSM-V diagnosis of moderate or severe substance use disorder (except for tobacco use disorder) or has a positive urine drug screen for prohibited substances at screening. 4. Have impaired hepatic (ALT/AST \>1.5 times higher than the upper limit of normal) or renal function (eGFR\<50 mL/min) 5. Previously defined hypersensitivity to Risperidone 6. History of neuromalignant syndrome (NMS) 7. Electroconvulsive therapy within 6 months of admission 8. Requires current use of agents that are strong inhibitors and inducers of cytochrome P450 2D6
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area Under the Curve (AUC) for Active Moiety, 9-hydroxy-risperidone and Risperidone | 6 months |
| Cmax for Active Moiety, 9-hydroxy-risperidone and Risperidone | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Safety and Efficacy of a Risperidone Implant as Assessed by the Positive and Negative Syndrome Scale (PANSS) | 12 months |
Countries
United States
Participant flow
Pre-assignment details
The product was sold to another company prior to data analysis. The new company closed before the results were completed, so no results are available for this study
Participants by arm
| Arm | Count |
|---|---|
| 600 mg Two, 300 mg Risperidone Implants
Risperidone Implant | 0 |
| 900 mg Three, 300 mg Risperidone Implants
Risperidone Implant | 0 |
| Total | 0 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Area Under the Curve (AUC) for Active Moiety, 9-hydroxy-risperidone and Risperidone
Time frame: 6 months
Population: The product was sold to another company prior to data analysis. The new company closed before the results were completed, so no results are available for this study.
Primary
Cmax for Active Moiety, 9-hydroxy-risperidone and Risperidone
Time frame: 6 months
Population: The product was sold to another company prior to data analysis. The new company closed before the results were completed, so no results are available for this study.
Secondary
Safety and Efficacy of a Risperidone Implant as Assessed by the Positive and Negative Syndrome Scale (PANSS)
Time frame: 12 months
Population: The product was sold to another company prior to data analysis. The new company closed before the results were completed, so no results are available for this study.