An Efficacy and Safety Study of Paliperidone Palmitate in Participants With Schizophrenia

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

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).

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

Details

• Lead Sponsor: Janssen Pharmaceutical K.K.
• Treatments: Paliperidone Palmitate

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)