Health Condition 1: F20- Schizophrenia
Conditions
Interventions
Intervention1: Paliperidone Palmitate 6-Month Formulation or Placebo: Double-Blind Phase
Participants will receive intramuscular injection of PP6M at dose of 700 or 1000 milligrams equivalent (mg eq.)
Sponsors
Johnson Johnson Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. 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 2. 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 3. Must be able, in the opinion of the investigator, to discontinue any antipsychotic medication other than PP1M) or PP3M during the Screening Phase 4. Must have a full Positive and Negative Syndrome Scale (PANSS) score of less than ( 5. Must have a body mass index (BMI) between 17 and 40 kilogram (kg)/meter2 (inclusive) and must have a body weight of at least 47kg at screening 6. Must be willing to receive gluteal injections of medication during the Double blind Phase
Exclusion criteria
Exclusion criteria: 1. Must not be receiving any form of involuntary treatment, such as involuntary psychiatric hospitalization, parole-mandated treatment, or court-mandated treatment 2. 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 3. Must not have a DSM-5 diagnosis of moderate to 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 4. Must not have a history of neuroleptic malignant syndrome or tardive dyskinesia 5. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Relapse During the Double-Blind (DB) PhaseTimepoint: Up to Month 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale ScoreTimepoint: Baseline, Month 3, 6, 9, 12, 15 and 18;Change From Baseline in PANSS Total and Subscale ScoreTimepoint: Baseline, Month 3, 6, 9, 12, 15 and 18;Change From Baseline in Personal and Social Performance (PSP) Total ScoreTimepoint: Baseline, Month 3, 6, 9, 12, 15 and 18;Percentage of Participants who Met the Criteria for Symptomatic RemissionTimepoint: Month 6 and Month 18 | — |
Countries
Argentina, Australia, Brazil, Bulgaria, Czech Republic, France, Germany, Hong Kong, Hungary, India, Italy, Malaysia, Mexico, Poland, Republic of Korea, Romania, Russian Federation, South Africa, Spain, Taiwan, Turkey, Ukraine, United States of America
Contacts
Public ContactDr Murtuza Bughediwala
Johnson & Johnson Private Limited
Outcome results
None listed