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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 3

Conditions: Schizophrenia

Treatments: Drug: Paliperidone palmitate 3 month formulation (PP3M)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02713282

CR108121

R092670SCH3015 (Other Identifier)

2015-004835-10 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

This is an international, multicenter (study conducted at multiple sites) study designed to estimate remission rates and assess treatment response, tolerability, and patterns of use of Paliperidone Palmitate 3-Month Formulation (PP3M) in a diverse population of participants with schizophrenia. The study will consist of a screening phase (Day -7 to Day 1), a 52-week, open-label, flexible-dose PP3M treatment phase and a follow up safety assessment 3 months ( +/-14 days ) after the month 12 visit or early discontinuation. Participants' Safety will be monitored throughout the study.

Enrollment: 306 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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306 participants in 1 patient group

Paliperidone palmitate 3 month formulation (PP3M)

Experimental group

Description:

Participants will receive intramuscular injection of Paliperidone Palmitate 3-Month Formulation (PP3M) on Day 1 at a starting dose of 175 milligram equivalent (mg eq.) up to 525 mg eq. based on last Paliperidone Palmitate 1-Month Formulation (PP1M) dose (at a dose of 3.5-fold multiple of the participant's last PP1M dose). Subsequent PP3M injections will be given at Month 3, Month 6, and Month 9 and dose can be adjusted flexibly in increments within the range of 175 to 525 mg eq.

Treatment:

Drug: Paliperidone palmitate 3 month formulation (PP3M)