A Study of Paliperidone Palmitate 3 Month Formulation for the Treatment of Patients With Schizophrenia

Janssen (J&J Innovative Medicine)

Status and phase

Completed

Phase 3

Conditions

Schizophrenia

Treatments

Drug: PP3M 525 mg eq.

Drug: PP3M 263 mg eq.

Drug: PP3M 175 mg eq.

Drug: Placebo (20% Intralipid emulsion)

Drug: PP3M 350 mg eq.

Study type

Interventional

Funder types

Industry

Identifiers

NCT01529515

CR100717

U1111-1135-1969 (Other Identifier)

R092670PSY3012 (Other Identifier)

2011-004676-11 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy of paliperidone palmitate 3 month formulation (PP3M) compared with placebo in delay of the time to first occurrence of relapse of the symptoms of schizophrenia.

Full description

This is a randomized (the study drug is assigned by chance), double blind (neither physician nor patient knows the treatment that the patient receives), parallel group (each group of patients will be treated at the same time), placebo-controlled (an inactive substance is compared with a drug to test whether the drug has a real effect in a clinical trial) multicenter study. The study consists of 4 phases: a Screening Phase (up to 3 weeks); a 17-week flexible dose open-label Transition Phase (open-label phase means that all people know the identity of the intervention); a 12-week fixed dose open-label Maintenance Phase; and a randomized, double-blind, fixed dose, placebo-controlled relapse prevention phase (referred to as the Double-blind Phase). Patients who meet specific stabilization criteria will enter the Double-blind Phase at Week 29. Patients will be randomly assigned, in a 1:1 ratio, to receive either a fixed dose of PP3M or placebo. The Double-blind Phase will be of variable duration; patients will remain in the study until they experience a relapse event or meet discontinuation criteria.

Enrollment

509 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Patients with schizophrenia for more than 1 year
A total score in the Positive and Negative Syndrome Scale (PANSS) < 120
Signed informed consent
Women must not be pregnant, breastfeeding, and if capable of pregnancy must practice an effective method of birth control
Men must agree to use a double-barrier method of birth control
Be medically stable on the basis of clinical laboratory tests, physical examination, medical history, vital signs, and electrocardiogram (ECG) Exclusion Criteria:
A diagnosis other than schizophrenia, e.g., dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, schizophreniform disorder, autistic disorder, primary substance-induced psychotic disorder, dementia-related psychosis
Relevant history or current presence of any significant or unstable medical condition(s) determined to be clinically significant by the Investigator (ie, obesity, diabetes, heart disease etc)
A diagnosis of substance dependence within 6 months before screening
History of neuroleptic malignant syndrome (NMS) or tardive dyskinesia
Clozapine use in the last 2 months when used for treatment-resistant or treatment-refractory illness
Clinically significant findings in biochemistry, hematology, ECG or urinalysis results
Any other disease or condition that, in the opinion of the investigator, would make participation not in the best interest of the patient or that could prevent, limit, or confound the protocol-specified assessments