A Study of Relapse Prevention and the Effectiveness of Long-acting Injectable Risperidone and Quetiapine Tablets in the Treatment of Patients With Schizophrenia or Schizoaffective Disorder
Condition: Schizophrenia; Psychotic Disorders
MeSH terms: Recurrence; Schizophrenia; Psychotic Disorders
Intervention: Aripiprazole; Risperidone Long Acting Injectable (LAI); Quetiapine
Intervention description: 10-30 mg oral once daily for 104 weeks; 25 mg injection every 2 weeks until week 104. Dosage may be increased or decreased in steps of 12.5 mg. Additional oral risperidone can be administered as required until a dose increase becomes effective.; Oral tablets are titrated from 50 mg daily to 300-400 mg daily in first 4 days. Subsequently treatment is maintained for 104 weeks and dosage can be adjusted with increments or decrements of 25 to 50 mg.
Intervention MeSH terms: Risperidone; Aripiprazole; Quetiapine Fumarate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 753.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Schizophrenia, relapse prevention; Antipsychotic agents; Long-acting risperidone; Quetiapine; Aripiprazole

Summary:

      The purpose of this study is to investigate whether a long-acting injectable formulation of
      risperidone provides better effectiveness over 2 years, as measured by the time to relapse,
      compared with quetiapine tablets in a routine psychiatric care setting. Aripiprazole will be
      investigated in a descriptive manner.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of schizophrenia or schizoaffective disorder according to the Diagnostic and
             Statistical Manual of Mental Diseases, 4th edition (DSM-IV)

          -  Patients currently treated with oral risperidone, olanzapine or a conventional
             neuroleptic monotherapy at doses not exceeding 6 mg risperdal, 20 mg olanzapine, or a
             conversion dose of 10 mg haloperidol for oral conventional agents

          -  Patients who are stable (judged clinically stable by the investigator and on a stable
             dose of medication for 4 weeks or longer) but not optimally treated (non-satisfactory
             treatment regarding symptoms or adverse events)

        Exclusion Criteria:

          -  Diagnosis other than schizophrenia or schizoaffective disorder by DSM-IV Axis I
             criteria

          -  Patients being treated with antipsychotic agents other than oral risperidone,
             olanzapine or conventional oral neuroleptic agents

          -  Patients with known hypersensitivity to oral risperidone, quetiapine, aripiprazole, or
             who are known non-responders to oral risperidone, quetiapine, aripiprazole or to
             previous treatment with at least 2 antipsychotic agents

          -  Patients treated with mood stabilizers or antidepressants who are not on stable dose
             for at least 3 months before study initiation

          -  Pregnant or nursing females, or those lacking adequate contraception