disambiguation
Conditions
Interventions
Upon meeting the response criteria, subjects will enter the 24-month treatment
phase for initiation of paliperidone palmitate or continuation of oral
antipsychotic therapy, in an open-label, rater-b
Sponsors
Janssen-Cilag
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Man or woman between 18 and 65 years of age, inclusive • The subject has a current diagnosis of schizophrenia according to DSM-IV, and has been recently diagnosed, i.e. between 1 and 5 years before screening, and was receiving antipsychotics in the past; • The subject has a history of two or more relapses requiring psychiatric hospitalization in the preceding 24 months, which may include the current acute episode. Daytime hospitalization is acceptable in those countries where this reflects standard of care in acutely ill patients. In countries where hospitalization for relapse is not clinical standard, the requirement for hospitalization is not required; • Subject must be experiencing at screening an acute schizophrenic episode with a PANSS total score at screening between 70 and 120, inclusive; • The subjects may benefit from a switch of antipsychotic medication to either paliperidone palmitate or one of the oral antipsychotics used in this study; • Otherwise healthy on the basis of physical examination, medical history and vital signs performed at screening. If there are abnormalities, they must be consistent with the underlying illness in the study population. • Woman are not pregnant; must not get pregnant • Subjects must be willing and able to fill out self-administered questionnaires; • Willing/able to adhere to the prohibitions and restrictions specified in this protocol; • The subject is cooperative and reliable, and agrees to receive regular injections and complete all aspects of the protocol; • Subjects must have 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.
Exclusion criteria
Exclusion criteria: •The subject*s psychiatric diagnosis is due to direct pharmacological effects of a substance (e.g., a drug of abuse or medication) or a general medical condition (e.g., clinically notable hypothyroidism); •First antipsychotic treatment ever; •Subject cannot be treated with an atypical oral antipsychotic (except oral clozapine) or oral haloperidol in monotherapy according to the investigator; •The subject is treatment resistant in the judgment of the investigator and/or currently (i.e., within the last 3 months) treated with clozapine; •The subject meets the DSM-IV definition of substance dependence (except for nicotine and caffeine) within 6 months prior to entry; subjects with current substance use or abuse, with the exception of intravenous drug use, will be allowed to enroll; •Known allergies, hypersensitivity, or intolerance to risperidone or paliperidone or its excipients •Any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subjects from meeting or performing study requirements; •The subject has received treatment with a long-acting injectable antipsychotic within three injection cycles prior to screening; •The subject has begun a psychotherapy program within the two months preceding the treatment phase baseline. Psychosocial treatment is not considered psychotherapy; •The subject received an investigational drug or used an investigational medical device within 60 days before the planned start of treatment, or has participated in more than one investigational drug trial in the past 12 months, or has planned use of other investigational drugs during the time frame of the trial, or is currently enrolled in an investigational study; •The subject has evidence of clinically significant hepatic, renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances in the past 6 months (as determined by medical history, clinical laboratory or ECG results, or physical examination) that would increase the risk associated with taking study medication or would confound the interpretation of the study; •Subjects with a narrowing or blockage of their gastrointestinal tract; •Inability to swallow the study medication whole with the aid of water (subjects may not chew, divide, dissolve, or crush the Paliperidone ER study medication, if applicable, as this may affect the release profile); •Contraindications, warnings and precautions for oral antipsychotics used in this study apply according to local Summaries of Product Characteristics (SmPCs); •History or current symptoms of tardive dyskinesia; •History of neuroleptic malignant syndrome; •Subject is involuntarily hospitalized; •Subject is pregnant or breast-feeding; •Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator. •Use of disallowed therapies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the 24-month treatment phase will be the time to relapse. The relapse criteria are based on criteria reported by Csernansky et al.40, and have been employed in several previous trials. Relapse in the current study is defined by any one of the following: •Psychiatric hospitalization; or •An increase in the level of psychiatric care (e.g., significant crisis intervention needed to avert hospitalization, clinically notable increases in the frequency or intensity of patient contact required to maintain outpatient status) and an increase of 25% from baseline in the total score on the PANSS (or an increase of 10 points if the base-line score was 40 or less); or •Deliberate self-injury; or •Suicidal or homicidal ideation that was clinically significant in the investigator*s judgment; or •Violent behavior resulting in clinically significant injury to another person or property damage; or •Substantial clinical deterioration, defined as a change score of 6 (*much worse*) or 7 (*very much worse*) on the Clinical Global Impressions Scale; or •The required dose of the antipsychotic exceeds the maximum approved dose. Key efficacy evaluations will include the following: •Rate of patients with relapse at the 24-month endpoint; •Rate of patients with psychiatric hospitalizations; •Psychiatric hospitalizations (total number and mean duration); •Response rate using PANSS and changes versus baseline in total PANSS and PANSS subscales; •Changes from baseline in levels of personal and social functioning measured using the PSP scale; •Global severity of illness overall score and changes measured using the CGI-S and CGI-C scales; •Measures of subject's mental health (SF-36; EQ5D) and well-being (SWN); •Subject treatment satisfaction (TSQM) and physician treatment satisfaction (7-point categorical scale). | — |
Secondary
| Measure | Time frame |
|---|---|
| SAFETY EVALUATIONS •A physical examination will be performed at screening and at endpoint; •Vital signs and weight will be measured at screening, at all visits during the 24-month treatment phase, and upon early withdrawal; •Height will be measured at screening; •A urine pregnancy test (for females of childbearing potential) will be performed at screening and at endpoint; •Extrapyramidal symptom rating scales (AIMS, SAS, and BARS) will be assessed at screening, and at Visits 2-4 and Visit 8-13 during the 24-month treatment phase and at endpoint; •(S)AE . OTHER EVALUATIONS •Health/social care utilization measured through HRUQ; •Measures of alcohol and substance use (CRAUS; CRSUS); •Measures of subject*s suicidality (ISST). | — |
Countries
Netherlands
Outcome results
None listed