Pharmacokinetics and Tolerability Study of Risperidone ISM® in Schizophrenia

Completed · Phase 2

Conditions studied: Schizophrenia

In brief

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.

Key facts

Study ID

NCT02086786

Run by

Rovi Pharmaceuticals Laboratories

People needed

70

Starts

2014-03-01

Expected to finish

2015-03-01

Last updated by the study team

2017-07-13

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Capable of providing informed consent.
• Male or female aged ≥18 years to ≤65 years.
• Current diagnosis of schizophrenia, according to Diagnostic and Statistical Manual
• Body mass index (BMI) ≥17 kg/m2 but ≤35 kg/m2.
• Medically stable over the last month, and psychiatrically stable
• On oral stable dosage of risperidone ≥4 mg daily as maintenance therapy.
• Total score ≤70 on the Positive and Negative Syndrome Scale.
• Using a medically accepted contraceptive method
• Agrees to washout all prohibited medications prior to baseline (day -1)

You may not qualify if…

• Informed consent obtained from a third party.
• Prisoners or patients who are compulsorily detained.
• Females who are breast-feeding and/or who have a positive pregnancy test.
• Presence of an uncontrolled, unstable clinically significant medical condition.
• Positive serology for Hepatitis B, Hepatitis C or anti-HIV 1 and 2 at screening.
• History of neuroleptic malignant syndrome.
• Current or past history of tardive dyskinesia.
• Positive urine drug or alcohol screen finding.
• Risk of committing self-harm or harm based on Columbia Suicidal Rating Scale.
• Taking more than one antidepressant.
• Use of depot antipsychotics within the last three months.
• Use of strong or moderate cytochrome P450 isoenzyme 3A4inducers
• Use of electroconvulsive therapy (ECT) within the last three months.
• Receipt of any investigational drugs within the last three months.
• Known or suspected allergy or hypersensitivity to risperidone
• Previous non-responder to risperidone treatment.

Where it is running

• St Louis Clinical Trials, LC — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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