A Study of Transition to the Paliperidone Palmitate 3-Month Formulation In Participants With Schizophrenia Previously Stabilized on the Paliperidone Palmitate 1-Month Formulation

• Status: Completed
• Trial end date: 2018-03-26
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to estimate the proportion of participants fulfilling criteria for symptomatic remission following a transition to 12 months treatment with flexible-dose paliperidone palmitate 3 month formulation (PP3M) in participants with schizophrenia previously adequately treated with paliperidone palmitate 1 month formulation (PP1M) for at least 4 months.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen-Cilag Ltd.
• Treatments: Paliperidone Palmitate

Criteria

Inclusion Criteria:

• Meets Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) criteria for a diagnosis of schizophrenia

• Able to read, understand, and sign the informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study

• Willing and able to fill out self-administered questionnaires

• Willing and able to adhere to the prohibitions and restrictions specified in the protocol

• A woman of childbearing potential must have a negative urine pregnancy test at Screening and baseline

• A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 6 months after receiving the last dose of study drug

Exclusion Criteria:

• His/her psychiatric diagnosis is due to direct pharmacological effects of a substance (example, a drug of abuse or medication) or a general medical condition (example, clinically notable hypothyroidism, organic brain disorder)

• Experienced intolerable side effects during treatment with paliperidone palmitate 1-month formulation (PP1M)

• Has a known hypersensitivity to paliperidone or risperidone

• Has received any other long-acting injectable antipsychotic medication other than PP1M within the last 4 months before the first injection of the study drug paliperidone palmitate 3-month formulation (PP3M)

• Has received clozapine during the last 3 months before the Screening visit

• Is considered to be at imminent risk of suicide, even after clinical intervention

• Has a serious unstable medical condition, including recent and present clinically relevant laboratory abnormalities

• Has a history or current symptoms of tardive dyskinesia or neuroleptic malignant syndrome

• Is a woman who is pregnant or breast-feeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of PP3M

• Has participated in an investigational drug trial in the 30 days prior to the Screening visit or is currently enrolled in an investigational study

• Has a current DSM-5 diagnosis of dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, autistic disorder, or intellectual disabilities and/or meets the DSM-5 definition of severe substance use disorder (except for nicotine and caffeine) within 6 months prior to screening; however, participants with mild or moderate substance use disorder, with the exception of intravenous drug use, will be eligible for enrollment