Study in Stabilized Schizophrenic Patients to Evaluate the Pharmacokinetics of Risperidone and 9-Hydroxy (OH)-Risperidone When Risperidone is Administered From a Polyurethane Implant
Completed · Phase 2
Conditions studied: Schizophrenia, Schizo-affective Disorder
In brief
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.
Key facts
- Study ID
- NCT02658357
- Run by
- Braeburn Pharmaceuticals
- People needed
- 66
- Starts
- 2015-10-01
- Expected to finish
- 2017-08-01
- Last updated by the study team
- 2020-02-19
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Segal Institute for Clinical Research 1201 North 37th Avenue — Hollywood, Florida, United States
Full record on ClinicalTrials.gov
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