Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: PP3M 175 mg eq.; PP3M 263 mg eq.; PP3M 350 mg eq.; PP3M 525 mg eq.; Placebo (20% Intralipid); PP1M 50 mg eq.; PP1M 75 mg eq.; PP1M 100 mg eq.; PP1M 150 mg eq.
Intervention description: Type= exact number, unit= mg eq., number= 175, form= injection, route= intramuscular use. One injection every third month for 48 weeks.; Type= exact number, unit= mg eq., number= 263, form= injection, route= intramuscular use. One injection every third month for 48 weeks.; Type= exact number, unit= mg eq., number= 350, form= injection, route= intramuscular use. One injection every third month for 48 weeks.; Type= exact number, unit= mg eq., number= 525, form= injection, route= intramuscular use. One injection every third month for 48 weeks.; Form= injection, route= intramuscular use. One injection monthly when not receiving active medication for 48 weeks.; Type= exact number, unit= mg eq., number= 50, form= injection, route= intramuscular use. One injection every month for 48 weeks.; Type= exact number, unit= mg eq., number= 75, form= injection, route= intramuscular use. One injection every month for 48 weeks.; Type= exact number, unit= mg eq., number= 100, form= injection, route= intramuscular use. One injection every month for 48 weeks.; Type= exact number, unit= mg eq., number= 150, form= injection, route= intramuscular use. One injection every month for 48 weeks.
Intervention MeSH terms: Soybean oil, phospholipid emulsion
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1429.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Schizophrenia; R092670; Paliperidone Palmitate; Paliperidone palmitate 1 month formulation (PP1M); Paliperidone palmitate 3 month formulation (PP3M)

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.
    

Eligibility 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