Estudio internacional multicéntrico prospectivo, aleatorizado, controlado, abierto, con evaluador ciego, de 24 meses de duración, comparando palmitato de paliperidona inyectable de larga duración con el tratamiento habitual con antipsicóticos orales en monoterapia en la prevención de recaídas en adultos con esquizofrenia

Phase 1

• Conditions: Recently diagnosed (1-5 years since diagnosis) schizophrenia.; MedDRA version: 12.0Level: LLTClassification code 10039626Term: Schizophrenia

• Registration Number: EUCTR2008-002247-16-ES
• Lead Sponsor: Janssen-Cilag International N.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-11-02
• Study Completion: 2013-02-27
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

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 must be:
?Premenarchal, or
?postmenopausal (for at least 1 year), or
?surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), or
?abstinent (at the discretion of the investigator/per local regulations), 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 [e.g., condoms, diaphragm, or cervical cap with spermicidal foam, cream, or gel], male partner sterilization) as local regulations permit
before entry, and must agree to continue to use the same method of contraception throughout the study. Prescription hormonal contraceptives (the ?pill?) should not contain less than 20 µg of estrogen and should not be used as the only method of birth control. Women using oral contraceptives should agree to use an additional birth control method.
?Women of childbearing potential must have a negative urine pregnancy test at screening;
?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.
?Men must agree to use a double barrier method of birth control and to not donate sperm during the study and for 3 months after receiving the last dose of study drug.
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

?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 (refer to Section 14.1, Physical Description of Study Drug(s);
?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: see section 8, Prestudy and Concomitant Therapy.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified