A Study of Paliperidone Palmitate 3 Month Formulation 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 emulsion)
Intervention description: Type= exact number, unit= mg eq., number= 175, form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria.; Type= exact number, unit= mg eq., number= 263, form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria.; Type= exact number, unit= mg eq., number= 350, form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria.; Type= exact number, unit= mg eq., number= 525, form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria.; Form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria.
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: 509.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Schizophrenia; R092670; Paliperidone Palmitate; Paliperidone palmitate 3 month formulation (PP3M)

Summary:

      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.
    

Eligibility 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