Study in Stabilized Schizophrenic Patients to Evaluate the Pharmacokinetics of Risperidone and 9-Hydroxy (OH)-Risperidone When Risperidone is Administered From a Polyurethane Implant

• Status: Completed
• Trial end date: 2017-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Braeburn Pharmaceuticals
• Treatments: Risperidone

Criteria

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