An Efficacy and Safety Study of Paliperidone Palmitate in Participants With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Paliperidone palmitate; Placebo
Intervention description: Paliperidone palmitate will be given intramuscularly as an initial loading dose of 150 milligram (mg) equivalents (eq.) on Day 1 and 100 mg eq. on Day 8, followed by 75 mg eq. on Day 36 and Day 64. Participants who complete double-blind period or discontinued early from double-blind period will have follow-up visits during post-observational period at Weeks 4, 8 and 12 after the last injection in the double-blind period. Participants will not receive any study drug during post-observational period.; Matching Placebo will be given intramuscularly (Injection of a drug into a muscle) on Day 1, Day 8, Day 36 and Day 64. Participants who complete double-blind period or discontinued early from double-blind period will have follow-up visits during post-observational period at Weeks 4, 8 and 12 after the last injection in the double-blind period. Participants will not receive any study drug during post-observational period.
Intervention MeSH terms: Paliperidone Palmitate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 323.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Paliperidone palmitate; Schizophrenia

Summary:

      The purpose of this study is to evaluate the efficacy and safety of paliperidone palmitate as
      compared with placebo in the treatment of participants with schizophrenia (psychiatric
      disorder with symptoms of emotional instability, detachment from reality, often with
      delusions [a false belief held in the face of strong differing evidence, especially as a
      symptom of psychiatric disorder] and hallucinations [imagining things], and withdrawal into
      the self).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants meeting Diagnostic criteria for schizophrenia according to Diagnostic and
             Statistical Manual of Mental Disorders, Fourth Edition Text Revision

          -  Women had to be: postmenopausal (for at least 2 years), surgically sterile (had a
             hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of
             pregnancy), abstinent (as judged by the investigator; per local regulations), or if
             sexually active, be practicing a highly effective method of birth control (eg,
             prescription oral contraceptives, contraceptive injections, contraceptive patch,
             intrauterine device, double-barrier method [eg, condoms, diaphragm, or cervical cap,
             with spermicidal foam, cream, or gel], male partner sterilization) as local
             regulations permitted, before entry, and had to agree to continue to use the same
             method of contraception throughout the study

          -  A Positive and Negative Syndrome Scale (PANSS) total score at screening and at
             baseline (Day 1) of 60 to 120

          -  Documented history of exposure to either a risperidone formulation or a paliperidone
             formulation and known to be tolerated before baseline (Day 1) (Even if the
             participant's experience of taking risperidone or paliperidone cannot be confirmed at
             the time of informed consent, the participant will be able to meet this criterion if
             the participant takes oral risperidone 2 mg/day or more or paliperidone ER 6 mg/day or
             more for at least 4 days between the day of informed consent and the day before
             baseline, and it is possible to confirm that there is no lack of tolerability in the
             participant)

          -  Women of childbearing potential must have a negative beta human chorionic gonadotropin
             pregnancy test at the screening urine pregnancy test

        Exclusion Criteria:

          -  Primary active Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition
             Text Revision Axis I diagnosis other than schizophrenia

          -  A Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision
             diagnosis of active substance dependence within 3 months before screening (nicotine
             and caffeine are not exclusionary)

          -  Relevant history or current presence of any significant or unstable cardiovascular,
             respiratory, neurological (including seizures or significant cerebrovascular), renal,
             hepatic, hematologic, endocrine, immunologic, or other systemic disease

          -  History or current presence of neuroleptic malignant syndrome or tardive dyskinesia

          -  Known or suspected hypersensitivity or intolerance to risperidone, paliperidone,
             Intralipid, or any of their excipients (including egg yolks, soybean oil,
             phospholipids, and glycerol)