Clinical trial NCT02713282 (phase 3, status: completed)
Conditions: schizophrenia
ICD codes: F20.0, F20.1, F20.2, F20.3, F20.5, F20.89, F20.9
Drugs: paliperidone palmitate 3 month formulation (pp3m)
SMILES: CC1=C(CCN2CCC(CC2)C2=NOC3=C2C=CC(F)=C3)C(=O)N2CCCC(O)C2=N1
Eligibility criteria:

        Inclusion Criteria:

          -  Meets Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5)
             criteria for a diagnosis of schizophrenia

          -  Able to read, understand, and sign the informed consent form (ICF) indicating that he
             or she understands the purpose of and procedures required for the study and are
             willing to participate in the study

          -  Willing and able to fill out self-administered questionnaires

          -  Willing and able to adhere to the prohibitions and restrictions specified in the
             protocol

          -  A woman of childbearing potential must have a negative urine pregnancy test at
             Screening and baseline

          -  A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted
             reproduction during the study and for 6 months after receiving the last dose of study
             drug

        Exclusion Criteria:

          -  His/her psychiatric diagnosis is due to direct pharmacological effects of a substance
             (example, a drug of abuse or medication) or a general medical condition (example,
             clinically notable hypothyroidism, organic brain disorder)

          -  Experienced intolerable side effects during treatment with paliperidone palmitate
             1-month formulation (PP1M)

          -  Has a known hypersensitivity to paliperidone or risperidone

          -  Has received any other long-acting injectable antipsychotic medication other than PP1M
             within the last 4 months before the first injection of the study drug paliperidone
             palmitate 3-month formulation (PP3M)

          -  Has received clozapine during the last 3 months before the Screening visit

          -  Is considered to be at imminent risk of suicide, even after clinical intervention

          -  Has a serious unstable medical condition, including recent and present clinically
             relevant laboratory abnormalities

          -  Has a history or current symptoms of tardive dyskinesia or neuroleptic malignant
             syndrome

          -  Is a woman who is pregnant or breast-feeding, or planning to become pregnant while
             enrolled in this study or within 6 months after the last dose of PP3M

          -  Has participated in an investigational drug trial in the 30 days prior to the
             Screening visit or is currently enrolled in an investigational study

          -  Has a current DSM-5 diagnosis of dissociative disorder, bipolar disorder, major
             depressive disorder, schizoaffective disorder, autistic disorder, or intellectual
             disabilities and/or meets the DSM-5 definition of severe substance use disorder
             (except for nicotine and caffeine) within 6 months prior to screening; however,
             participants with mild or moderate substance use disorder, with the exception of
             intravenous drug use, will be eligible for enrollment