Pharmacokinetics, Safety and Tolerability of Different Formulations and Dose Strengths of Quarterly Risperidone (QUAR) in Patients With Schizophrenia

Korábbi kezelés

• Positive test result for drugs of abuse or alcohol unless the positive finding can be accounted for by documented prescription use.
• Unwilling to discontinue any of the prohibited medications prior to the baseline visit or unable to safely washout such medication without significant destabilization or increased risk of self-harm (suicide).
• Receipt study drug in another investigational study in the last 90 days.

Más betegség

• Presence of an uncontrolled, unstable, clinically significant medical condition that in the opinion of the investigator could interfere with the interpretation of safety and PK evaluations
• History of neuroleptic malignant syndrome and current or past history of clinically significant tardive dyskinesia.
• The participant has a primary diagnosis other than schizophrenia diagnosis that is primarily responsible for current symptoms and functional impairment

Laborértékek

• If female, a positive serum pregnancy test, or planning to become pregnant between signing informed consent and 1 month after the last dose of study drug or is breastfeeding a child.

Egyéb

• In the investigator's opinion, at imminent risk of committing self-harm or harm to others.
• Current participation in any other clinical trial.

• Capable of providing informed consent.
• Male or female aged ≥ 18 years to < 65 years with BMI ≥17.0 to ≤35.0 kg/m2
• Current diagnosis of schizophrenia, according to the Diagnostic and DSM-5 criteria.
• Medically stable over the last month, and psychiatrically stable without significant symptom exacerbation over the last three months based on the investigator's judgment
• currently taking oral risperidone as maintenance therapy
• Score of ≤ 4 (moderately ill at most) on the Clinical Global Impression - Severity of Illness (CGI-S)
• If a sexually active female of childbearing potential, using a medically accepted method of birth control.