PALMFlexS: Paliperidone Palmitate Flexible Dosing in Schizophrenia

• Conditions: Schizophrenia; MedDRA version: 14.0Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2009-018022-30-DE
• Lead Sponsor: Janssen-Cilag International N.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-22
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

•Man or woman of minimally 18 years of age;
•Subjects who meet the DSM-IV criteria for schizophrenia;
•a) Subject is currently non-acute, i.e. on the same antipsychotic medication used for the treatment of schizophrenia given in an adequate dose and a CGI-S change less than or equal to 1 in the past 4 weeks before enrollment. Subject has been given an adequate dose of either an appropriate oral antipsychotic, or one of the following LAI antipsychotics: haloperidol decanoate, flupentixol decanoate, fluphenazine decanoate, zuclopenthixol or LAI risperidone, for an adequate period of time prior to enrollment, but current treatment is considered unsuccessful due to one or more of the following reasons:
- lack of efficacy, or
- lack of tolerability or safety, or
- lack of compliance
- patient’s wish

Lack of efficacy is defined as subjects with a baseline total PANSS score = 70 or = 2 items scoring = 4 in the PANSS positive or negative subscale or = 3 items scoring = 4 in the PANSS general psychopathology subscale, as judged by the investigator.

Lack of tolerability is defined as the presence of clinically relevant (i.e., either clinically relevant according to the investigator and/or intolerable to the subject) side effects with the current antipsychotic medication.

OR

b) Subjects with acute symptoms of schizophrenia, previously treated with an oral antipsychotic, having a baseline total PANSS score = 80 and a baseline CGI-S score = 4;
•The subjects may benefit from a switch of antipsychotic medication to paliperidone palmitate at the discretion of the investigator;
•In the opinion of the investigator, subject is otherwise healthy on the basis of a 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;
•Women must be:
–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 a highly 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 micrograms 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

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 i.e., subject has never been treated with antipsychotics before and antipsychotic treatment given in this study will be the first antipsychotic treatment that the subject will have ever received;
•On clozapine during the last 3 months;
•Subjects who remain at imminent risk of suicide even after clinical intervention;
•Serious unstable medical condition, including recent and present clinically relevant laboratory abnormalities;
•History or current symptoms of tardive dyskinesia;
•History of neuroleptic malignant syndrome;
•Subject received an investigational drug or used an investigational medical device within 3 months 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;
•Pregnant or breast-feeding female;
•Known allergies, hypersensitivity, or intolerance to risperidone or paliperidone or its excipients (refer to Section 14.1, Physical Description of Study Drug(s). All subjects without source documentation of previous risperidone or paliperidone exposure must undergo oral tolerability testing. Paliperidone ER will be administered for 2 days prior to Day 1 (Visit 2) to these subjects before the first injection of study drug. Only those subjects who demonstrate an ability to tolerate the drug as judged by the treating physician, will be eligible for treatment with paliperidone palmitate.
•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;
•Subjects who have evidence of alcohol or drug dependence (except for nicotine and caffeine) according to DSM-IV Axis 1 criteria within 6 months prior to entry. However, subjects with current substance use or abuse, with the exception of intravenous drug use, will be eligible for enrolment;
• 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.

Study & Design

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