Phase 2
Completed N=66
Study in Stabilized Schizophrenic Patients to Evaluate the Pharmacokinetics of Risperidone and 9-Hydroxy (OH)-Risperidone When Risperidone is Administered From a Polyurethane Implant
Schizophrenia · Schizo-affective Disorder
Source: ClinicalTrials.gov NCT02658357 ↗
Enrolled (actual)
66
Serious AEs
—
Results posted
Feb 2020
Primary outcomePrimary: Area Under the Curve (AUC) for Active Moiety, 9-hydroxy-risperidone and Risperidone
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve (AUC) for Active Moiety, 9-hydroxy-risperidone and Risperidone |
— | — |
| PRIMARY Cmax for Active Moiety, 9-hydroxy-risperidone and Risperidone |
— | — |
| SECONDARY Safety and Efficacy of a Risperidone Implant as Assessed by the Positive and Negative Syndrome Scale (PANSS) |
— | — |
Eligibility Criteria
Inclusion Criteria
- Subject (and/or a subject's authorized legal representative) has provided written informed consent
- 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
- Subject is male or female between 18 to 60 years of age
- 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
- Hospitalized or required acute crisis intervention for symptom exacerbation in the 60 days prior to admission as determined by the Investigator
- 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
- 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.
- Have impaired hepatic (ALT/AST >1.5 times higher than the upper limit of normal) or renal function (eGFR<50 mL/min)
- Previously defined hypersensitivity to Risperidone
- History of neuromalignant syndrome (NMS)
- Electroconvulsive therapy within 6 months of admission
- Requires current use of agents that are strong inhibitors and inducers of cytochrome P450 2D6
Data sourced from ClinicalTrials.gov (NCT02658357). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.