An Efficacy and Safety Study of Risperidone Long-Acting Microspheres in Participants With Schizophrenia, Schizophreniform or Schizoaffective Disorders
Condition: Schizophrenia; Schizophreniform Disorder; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Intervention: Risperidone
Intervention description: Risperidone 25 milligram (mg) will be given as intramuscular injection for every 2 weeks up to 6 months. Participants with persistent symptoms and/or requiring higher doses of antipsychotics will be administered higher doses of risperidone. Doses will be adjusted as per Investigator's discretion.
Intervention MeSH terms: Risperidone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Schizophrenia; Schizophreniform Disorder; Schizoaffective Disorder; Risperidone; Risperdal consta

Summary:

      The purpose of this study is to evaluate the efficacy and safety of long acting injectable
      microspheres of risperidone in participants with schizophrenia (psychiatric disorder with
      symptoms of emotional instability, detachment from reality, often with delusions and
      hallucinations, and withdrawal into the self), schizophreniform or schizoaffective disorders
      (disorders in which there is a loss of ego boundaries or a gross impairment in reality
      testing with delusions or prominent hallucinations).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Symptomatically stable participants defined as a) participants with treatment on
             outpatient and inpatient basis for at least 4 weeks before entering the study, and b)
             Positive and Negative Syndrome Scale (PANSS) Positive Subscale Score less than or
             equal to (<= ) 3 (1-7), including conceptual disorganization, suspicion, hallucinatory
             conduct and delirium (state of violent mental agitation)

          -  Participants under antipsychotic treatment with extrapyramidal symptoms, persistent
             negative symptoms or lack of adherence defined as irregular administration of
             medication in the last 2 weeks

          -  Participants who have given their informed consent in writing, or at least, by their
             family member or personal representative

        Exclusion Criteria:

          -  Participants taking first antipsychotic treatment in his/her life

          -  Participants with any other psychotic disorder different to the previously mentioned
             in the inclusion criteria

          -  Pregnant or nursing women

          -  History of neuroleptic malignant syndrome (potentially fatal syndrome associated
             primarily with the use of antipsychotic drugs and clinical features include diffuse
             muscle rigidity, tremor, high fever) or current symptoms of tardive dyskinesia (a
             neurological disorder characterized by involuntary movements of the face and jaw)

          -  Participants with known intolerance or lack of response to risperidone