None listed
Conditions
Interventions
Drug : 1. Paliperidone Tolerability Test: For those subjects without documented tolerability to oral or injecctable risperidone or paliperidone, paliperidone ER 6mg tablets will be administered for 4
Sponsors
Janssen Korea
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female 18 (or the legal age of consent in the jurisdiction in which the study is taking place) to 70 years of age, inclusive 2. Must have a valid reason to discontinue current antipsychotic therapy 3.1. Female subjects must be postmenopausal for at least 2 years, surgically sterile, or practicing or agree to practice an effective method of birth control if they are sexually active before entry and throughout the study. Women of childbearing potential must have a negative serum pregnancy test result at screening, and have a negative urine pregnancy test result at baseline, before receiving the first dose of study drug. Women of child-bearing potential included in the study must continue to use one of the above-mentioned contraceptive methods for a minimum of 6 months after her last injection of study medication. Contraceptive measures should be used that are consistent with local regulations regarding use of birth control methods for subjects participating in clinical studies 4. Male subjects must agree to use a double-barrier method of birth control and to not donate sperm during the study and for 6 months after receiving the last dose of study drug 5. Signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. 6. To participate in the optional pharmacogenomic component of this study, subjects must have signed the informed consent form for pharmacogenomic research indicating willingness to participate in the pharmacogenomic component of the study. Refusal to give consent for this component does not exclude a subject from participation in the clinical study 7. Fluent in the language of the investigator and study staff 8. Able and willing to meet or perform study requirements. If a subject is unable to read the questions, study personnel may read documents and the subject may then mark his/her choice. 9.1. Have an identified support person considered reliable by the investigator in providing support to the subject to ensure compliance with study treatment, outpatient visits, and protocol procedures, including alerting trial staff to any signs of impending relapse 10. Met diagnostic criteria for schizophrenia according to DSM-IV-TR for at least 1 year before screening 11. Have a total PANSS score of <120 at screening and baseline (Day 1) 12. Body mass index of = 17.0 at screening 13. Must have a stable place of residence for the previous 3 months prior to screening and for the foreseeable future 14. Be medically stable on the basis of physical examination, medical history, vital signs, and 12 lead electrocardiogram (ECG) performed at screening. IF there are abnormalities, they must be consistent with the underlying illness in the study population 15. Be medically stable on the basis of clinical laboratory tests performed at screening. If the results of the clinical laboratory tests are outside the normal reference ranges, the subject may be included only if deemed clinically not significant by the investigator. This determination must be recorded in the subject’s source documents. 16. Subjects who are taking another LAI antipsychotic (including PP1M or Risperdal CONSTA) prior to study entry must be symptomatically stable in the judgment of the investigator.
Exclusion criteria
Exclusion criteria: 1. A primary, active DSM-IV-TR Axis I diagnosis other than schizophrenia 2. A DSM-IV-TR diagnosis of active substance dependence within 6 months before screening 3. Attempted suicide within 12 months before screening or are at imminent risk of suicide or violent behavior as clinically assessed by the investigator. Subjects must answer “no” to items 1 and 2 in the Columbia Suicide Severity Rating Scale Since Last Visit Version administered at baseline in order to be enrolled in the study 4. Involuntarily committed to psychiatric hospitalization 5. Relevant history or current presence of any significant or unstable cardiovascular, respiratory, neurological, renal, hepatic, hematologic, endocrine, morbid obesity, immunologic or other systemic disease, encephalopathic syndrome, mental retardation, risk factors for prolonged QT interval, torsade de pointes or sudden cardiac death 6. Biochemistry, hematology, ECG or urinalysis results that are not within the laboratory’s normal reference range and are deemed to be clinically significant by the investigator 7. History or evidence of clinically significant hepatic disease at screening 8. History of neuroleptic malignant syndrome (NMS) or tardive dyskinesia 9. For women, pregnancy, breast-feeding, or planning to become pregnant while enrolled in this study or within 6 months after her last injection of study medication 10. History of any malignancy within the previous 5 years, with the exception of basal cell carcinomas 11. History of treatment resistance as defined by failure to respond to 2 adequate trials with adequate doses of different antipsychotic medications 12. Clozapine use in the last 2 months for treatment resistant or treatment refractory disease 13. Exposure to an experimental drug, experimental biologic, or experimental medical device within 30 days before screening OR participation in 2 or more interventional clinical trials in the year prior to screening 14. Known or suspected hypersensitivity or intolerance to risperidone, paliperidone, 20% Intralipid, or any of their excipients 15. History of life-threatening allergic reaction to any drug 16. Subjects with known or suspected Stevens Johnson Syndrome after exposure to phenytoin, carbamazepine, barbiturates, or lamotrigine 17. For subjects requiring oral tolerability testing: ability to swallow oral paliperidone ER tablets whole with the aid of water 19.1. History of disallowed therapies: Electroconvulsive therapy (ECT) with 60 days before screening Nonselective/irreversible monoamine oxidase inhibitors (MAOI) antidepressants within 30 days before screening Other antidepressants unless at a stable dosage for 30 days before screening Other oral antipsychotics should be tapered if necessary and washed out during screening. Washout must be arranged so that the last dose of antipsychotic is given by Day -1 Mood stabilizers, including lithium, valproic acid, topiramate, carbamazepine, and lamotrigine, should be tapered and washed out during screening. Washout must be arranged so that the last dose is given by Day -1 Other prescription, over-the-counter, or herbal agents with psychoactive properties should be tapered and washed out such that the last dose is given by Day -1 Subjects receiving PP1M at doses 150mg eq, with a nonstandard injection cycle subjects receiving Risperdal CONSTA at doses 50 mg, with a nonstandard injection cycle 20. Unable to provide their own consent 21. Previously participated
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint will be the time to first relapse event in the Double-blind Phase. For the primary analysis, time to relapse is defined as the time between randomization to treatment in | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary efficacy endpoints will include the change from baseline to endpoint during the Double-blind Phase in PANSS (total and subscales), CGI-S, and PSP.;Secondary efficacy endpoints will include the change from baseline to endpoint during the Double-blind Phase in CGI-S.;Secondary efficacy endpoints will include the change from baseline to endpoint during the Double-blind Phase in PSP. | — |
Countries
Korea, Republic of
Contacts
Public ContactChulEung Kim
Inha University Hospital
Outcome results
None listed