Schizophrenia | Pharmacokinetics and Tolerability Study of Risperidone ISM® in Schizophrenia
Schizophrenia research study
What is the primary objective of this study?
To characterize the pharmacokinetics (PK) of the injectable intramuscular (IM) long-acting formulation (in situ microparticle, ISM) of risperidone over four IM injections in the gluteal and deltoid muscle at 28-day intervals and at one dose strength (75 mg) in patients with schizophrenia.
Who is eligible to participate?
Inclusion Criteria: 1. Capable of providing informed consent. 2. Male or female aged ≥18 years to ≤65 years. 3. Current diagnosis of schizophrenia, according to Diagnostic and Statistical Manual 4. Body mass index (BMI) ≥17 kg/m2 but ≤35 kg/m2. 5. Medically stable over the last month, and psychiatrically stable 6. On oral stable dosage of risperidone ≥4 mg daily as maintenance therapy. 7. Total score ≤70 on the Positive and Negative Syndrome Scale. 8. Using a medically accepted contraceptive method 9. Agrees to washout all prohibited medications prior to baseline (day -1) Exclusion Criteria: 1. Informed consent obtained from a third party. 2. Prisoners or patients who are compulsorily detained. 3. Females who are breast-feeding and/or who have a positive pregnancy test. 4. Presence of an uncontrolled, unstable clinically significant medical condition. 5. Positive serology for Hepatitis B, Hepatitis C or anti-HIV 1 and 2 at screening. 6. History of neuroleptic malignant syndrome. 7. Current or past history of tardive dyskinesia. 8. Positive urine drug or alcohol screen finding. 9. Risk of committing self-harm or harm based on Columbia Suicidal Rating Scale. 10. Taking more than one antidepressant. 11. Use of depot antipsychotics within the last three months. 12. Use of strong or moderate cytochrome P450 isoenzyme 3A4inducers 13. Use of electroconvulsive therapy (ECT) within the last three months. 14. Receipt of any investigational drugs within the last three months. 15. Known or suspected allergy or hypersensitivity to risperidone 16. Previous non-responder to risperidone treatment.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Risperidone ISMFour doses of 75 mg of Risperidone ISM as intramuscular (IM) injection into the deltoid muscle at 28-day intervals. Four doses of 75 mg of Risperidone ISM as intramuscular injections into the gluteal muscle at 28-day intervals.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Gluteus (Risperidone ISM)Risperidone ISM (75 mg) injection in the gluteal muscle at 28-day intervals
Deltoid (Risperdione ISM)Risperidone ISM (75 mg) injection in the deltoid muscle at 28-day intervals
Start Date: March 2014
Completed Date: March 2015
Phase: Phase 2
Primary Outcome: Peak Plasma Concentration (Cmax) for Active Moiety
Secondary Outcome: Accumulation Ratio (RA) for Active Moiety
Study sponsors, principal investigator, and references
Principal Investigator: Jordi Llaudó, M.D
Lead Sponsor: Rovi Pharmaceuticals Laboratories