Status:
COMPLETED
A Study of Paliperidone Palmitate 6-Month Formulation
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Schizophrenia
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to demonstrate that injection cycles consisting of a single administration of paliperidone palmitate 6-month (PP6M) are not less effective than 2 sequentially administered...
Detailed Description
The primary hypothesis of this study is that the efficacy of PP6M is non-inferior to PP3M for preventing relapse in participants with schizophrenia who were previously stabilized on corresponding dose...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Must meet the diagnostic criteria for schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5) for at least 6 months before screening
- Must be receiving treatment with paliperidone palmitate (as either the paliperidone palmitate 1-month (PP1M) or paliperidone palmitate 3-month (PP3M) formulation), or injectable risperidone, or any oral antipsychotic
- Must be able, in the opinion of the investigator, to discontinue any antipsychotic medication other than PP1M) or PP3M during the Screening Phase
- Must have a full Positive and Negative Syndrome Scale (PANSS) score of less than (\<) 70 points at screening
- Must have a body mass index (BMI) between 17 and 40 kilogram (kg)/meter (m)\^2 (inclusive) and must have a body weight of at least 47 kg at screening
- Must be willing to receive gluteal injections of medication during the Double-blind Phase
- Exclusion Criteria
- Must not be receiving any form of involuntary treatment, such as involuntary psychiatric hospitalization, parole-mandated treatment, or court-mandated treatment
- Must not have attempted suicide within 12 months before screening and must not be at imminent risk of suicide or violent behavior, as clinically assessed by the investigator at the time of screening
- Must not have a DSM-5 diagnosis of moderate or severe substance use disorder (except for nicotine and caffeine) within 6 months of screening; however, acute or intermittent substance use prior to screening is not exclusionary, depending upon the clinical judgment of the investigator
- Must not have a history of neuroleptic malignant syndrome or tardive dyskinesia
- Must not have a history of intolerability or severe reactions to moderate or higher doses of antipsychotic medications and must not have any other factors that would, in the judgment of the investigator, indicate that treatment with moderate or higher doses of paliperidone palmitate would be intolerable or unsafe
Exclusion
Key Trial Info
Start Date :
November 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 8 2020
Estimated Enrollment :
841 Patients enrolled
Trial Details
Trial ID
NCT03345342
Start Date
November 20 2017
End Date
May 8 2020
Last Update
April 29 2025
Active Locations (138)
Enter a location and click search to find clinical trials sorted by distance.
1
Woodland Research Northwest
Rogers, Arkansas, United States, 72758
2
California Pharmaceutical Research Institute, Inc.
Anaheim, California, United States, 92804
3
ATP Clinical Research
Costa Mesa, California, United States, 92626
4
Collaborative NeuroScience Network
Garden Grove, California, United States, 92845