Pharmacokinetics and Tolerability Study of Risperidone ISM® in Schizophrenia
| Status: | Completed |
|---|---|
| Conditions: | Schizophrenia |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 11/8/2014 |
| Start Date: | March 2014 |
| End Date: | January 2015 |
| Contact: | Jordi Llaudó, M.D. |
| Email: | jllaudo@rovi.es |
| Phone: | 00 34 91 151 99 00 |
Multicenter, Open-label, Two-arm, Parallel-design, Repeat-dose Clinical Trial to Evaluate the Pharmacokinetics, Safety, and Tolerability of Four Intramuscular Injections of Risperidone ISM® 75 mg, at 28 Day Intervals in Patients With Schizophrenia
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.
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.
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.
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