Long-Acting Injectable Risperidone in the Treatment of Schizophrenia
Condition: Schizoaffective Disorder; Schizophrenia
MeSH terms: Schizophrenia; Psychotic Disorders
Intervention: IM risperidone; oral antipsychotic medication
Intervention description: long-acting injectable risperidone; doctor's choice (excluding other long-acting injectable medications but not specifying any particular oral agents or dosages)
Intervention MeSH terms: Risperidone; Antipsychotic Agents
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 382.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      In the proposed study 450 veterans with a primary diagnosis of schizophrenia who had at least
      one psychiatric hospitalization for schizophrenia in the previous 2 years would be randomly
      assigned at 16 VA medical centers to long-acting injectable risperidone or doctor's choice of
      oral antipsychotic medication (i.e., excluding other long-acting injectable medications, but
      not specifying any particular oral agents or dosages). Recruitment would take 27 months to
      complete, and the study would continue for a third year to allow 9 months of follow-up for
      the last patient recruited. All patients would be treated from the time of entry up to the
      end of the three-year study period. Follow-up assessments would continue quarterly.
      Treatments would not be blinded since giving placebo injections to the comparison group would
      interfere with the goal of comparing the acceptability of two different methods of medication
      administration. However, end points will be blindly rated.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 18 years or older.

          2. Diagnosed with schizophrenia or schizoaffective disorder by the Structured Clinical
             Interview for Diagnosis (SCID) (Spitzer and First et al., 1996).

          3. Patients should

               1. have been hospitalized in the two years before study entry on a psychiatric
                  inpatient unit, or

               2. document explicit current evidence of increased use of outpatient services such
                  as additional visits, day treatment or non-hospital residential treatment,
                  increased dosage of medications or addition of concomitant psychotropic
                  medications.

             The b criterion will promptly be adjudicated by the study chairmen on a case-by case
             basis to insure credibility.

          4. .Adequate transportation is available and the participant lives within a travel time
             of less than 1.5 hours, allowing attendance at all scheduled visits.

          5. Use of an acceptable method of birth control by female patients who have a possibility
             of becoming pregnant (safety concerns).

          6. Able to demonstrate decisional capacity in order to give informed consent as assessed
             by the MacArthur Competence Assessment Tool (MacCAT) (Appelbaum and Grisso, 1996).
             Guardian consent is acceptable where applicable.

          7. Dually diagnosed patients with both schizophrenia and addictive disorders would be
             included in this study but should not be in need of acute detoxification for
             physiologic substance dependence (excluding nicotine) in the past 30 days.

        Exclusion Criteria:

          1. Physiologic substance dependence requiring detoxification (excluding nicotine) in the
             past 30 days (substance abuse is not an exclusion).

          2. Intolerance of risperidone.

          3. Intolerance of intramuscular injection.

          4. Current treatment with depot antipsychotic medication.

          5. Current treatment with oral clozapine or presence of refractory schizophrenia that, in
             the treating psychiatrist's opinion, requires clozapine.

          6. Hepatic or renal problems AST or ALT (>2 times upper limit of normal);

          7. Elevated bilirubin (>1.2), BUN (>24), creatinine (>1.7).

          8. Unstable, serious medical condition or one requiring acute medical treatment, or
             anticipation of hospitalization for extended care.

          9. Dementia, epilepsy, insulin-dependent diabetes, anticoagulation with coumadin.

         10. Unstable living arrangements or not planning to remain in the area for the next year.

         11. Legal entanglements or pending legal charges with potential of incarceration.

         12. Assault or suicide gesture currently needing acute intervention.

         13. Concurrent participation in another clinical trial with an investigational drug during
             the last 30 days.

         14. Pregnant or lactating women or women planning to become pregnant.