Schizophrenia MedDRA version: 9.1 Level: LLT Classification code 10039626 Term: Schizophrenia
Conditions
Interventions
Trade Name: INVEGA*28CPR 3MG R.P.
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Paliperidone
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3
Sponsors
JANSSEN-CILAG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible to enroll in this trial, all subjects must meet all of the following criteria: Subject meets the DSM-IV criteria for schizophrenia; Male or female, between 18 and 45 years of age, inclusive; Subject must be experiencing psychotic symptoms, with a PANSS total score at screening of ≥70, ≤100; Symptomatic subject who needs to be switched from the current oral antipsychotic therapy due to insufficient efficacy on symptoms (e.g. negative, positive, general) or due to side effects; Subject is followed as outpatients; Subject is able to read, understand and sign the Institutional Review Board (IRB)-approved informed consent form; Female subjects must be postmenopausal for at least 1 year, surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), abstinent (at the discretion of the investigator), or, if sexually active, be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method, male partner sterilization before entry and throughout the study. Female subjects must also have a negative urine pregnancy test at screening; Subject must be willing and able to fill out self-administered questionnaires. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects who meet one or more of the following criteria cannot be selected: -Acute psychotic relapse that requires hospitalization; -First antipsychotic treatment ever; -On clozapine or a long-acting injectable antipsychotic during the last 3 months; -Serious unstable medical condition, including known clinically relevant laboratory abnormalities; -History or current symptoms of tardive dyskinesia; -History of neuroleptic malignant syndrome; -Judged to be at high risk for adverse events, violence, or self-harm; -Pregnant or breast-feeding female; -Participation in an investigational drug trial in the 30 days prior to selection; -Inability to swallow the study medication whole with the aid of water (subjects may not chew, divide, dissolve, or crush the study medication, as this may affect the release profile); -Subjects with a narrowing or blockage of their gastro-intestinal tract; -Subjects with current or known history (over the past 6 months) of substance dependence according to DSM-IV Criteria; -Known hypersensitivity to paliperidone ER or risperidone -Employees of the investigator or study center, persons with direct involvement in the proposed study or other studies under the direction of that investigator or study center, or family members of the employees or the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To explore the effect of flexible doses of extended-release (ER) paliperidone in symptomatic subjects with schizophrenia with a duration of illness < 10 years by measuring the change in total PANSS score from baseline to endpoint.;Primary end point(s): The primary efficacy endpoint will be the change in total PANSS score measured at the end of the study (Week 13 or last post-baseline evaluation) versus baseline;Secondary Objective: To explore tolerability,safety,efficacy,disease severity, functioning and patients' subjective experiences and attitudes toward treatments by the following measurements: -assessing the efficacy on psychotic symptoms (Positive and Negative Syndrome Scale [PANSS] subscores); -assessing the proportion of subjects improving = 30% in total PANSS score from baseline to endpoint; -assessing the patients’ subjective experience and attitude towards their illness and medication (Subjective Well-being Under Neuroleptic [SWN 20] and Drug Attitude Inventory [DAI 30]) -assessing disease severity (Clinical Global Impression–Severity Scale [CGI-S]); -assessing personal and social functioning (Personal and Social Performance Scale [PSP]); -assessing quality of sleep and daytime drowsiness (11-point categorical evaluation scale); assessing side effects profiles by means of the Extrapyramidal Symptom Rating Scale (ESRS), body weight, vital signs, physical examination and adverse events (AEs). | — |
Countries
Italy
Outcome results
None listed