Last updated on May 2016

A Study of Transition to the Paliperidone Palmitate 3-Month Formulation In Participants With Schizophrenia Previously Stabilized on the Paliperidone Palmitate 1-Month Formulation


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Schizophrenia
  • Age: Between 18 - 50 Years
  • Gender: Male or Female
  • Other:
    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

You may not be eligible for this study if the following are true:

  • 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
    yndrome
    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

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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