Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Patients With Schizophrenia

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to demonstrate that a paliperidone palmitate 3 month formulation (PP3M) is as effective as the paliperidone palmitate 1 month formulation (PP1M) in the treatment of patients with schizophrenia who have been stabilized on PP1M.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Paliperidone Palmitate; Soybean oil, phospholipid emulsion

Criteria

Inclusion Criteria:

• Patients with schizophrenia for more than 1 year and whose symptoms are worsening in the opinion of the investigator

• A total score in the Positive and Negative Syndrome Scale (PANSS) between 70 and 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