A Study of Risperidone Long-Acting Injection Versus Oral Antipsychotics in Schizophrenia Participants With a History of Being Poorly Compliant With Taking Their Medication
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Risperidone long-acting injection (LAI); Oral atypical Antipsychotic
Intervention description: Risperidone LAI 25 milligram (mg), 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection will be administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic will also be administered in the first 3 weeks following the dose increase. Duration of treatment will be 24 months.; Oral atypical antipsychotic will be administered as per local label practice for 24 months. Participants will be switched to another atypical oral therapy as per Investigator's discretion.
Intervention MeSH terms: Risperidone; Antipsychotic Agents
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 167.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Schizophrenia; Risperidone; Risperdal Consta

Summary:

      The purpose of this study is to evaluate risperidone long-acting injection (an antipsychotic
      medication) versus oral antipsychotics in schizophrenia (psychiatric disorder with symptoms
      of emotional instability, detachment from reality, often with delusions and hallucinations,
      and withdrawal into the self) participants with a history of being poorly compliant with
      taking their medication.
    

Eligibility criteria:

        Inclusion Criteria: - Diagnosis of schizophrenia (psychiatric disorder with symptoms of
        emotional instability, detachment from reality, often with delusions and hallucinations,
        and withdrawal into the self) as per Diagnostic and Statistical Manual of Mental Disorders,
        Fourth Edition Text revision (DSM-IV TR)- Have had at least 2 hospitalizations or 2
        clinical worsening of symptoms, over the past 2 years because of deteriorating adherence -
        Is currently receiving treatment with an antipsychotic per local product label guidelines,
        and has a history in the last 5 years of a satisfactory response (minimum of 6 weeks) to
        oral antipsychotics (excluding clozapine) - On monotherapy antipsychotic treatment as per
        local product label guidelines, at Baseline -Female participants must be surgically
        sterile, or practicing an effective method of birth control before entry and throughout the
        study, and have a negative urine pregnancy test at screening before study entry Exclusion
        Criteria: - Participants with a primary DSM-IV TR Axis I diagnosis other than schizophrenia
        - Female participants who are currently pregnant or breastfeeding or planning a pregnancy
        within 2 years of trial start - Have a serious, unstable and untreated medical illnesses,
        such as vascular or cardiovascular disease, history of liver or kidney disease, significant
        cardiac (having to do with the heart), pulmonary (having to do with the lungs),
        gastrointestinal, endocrine, neurological (pertaining to the nervous system) or metabolic
        disturbances - At significant risk of suicide or violence at study start - Evidence of
        substance dependence (except for nicotine and caffeine dependence) according to DSM-IV TR
        criteria diagnosed in the last month prior to entry