High Dose Risperidone Consta for Patients With Schizophrenia With Poor Response to Risperidone

This six month double-blind,randomized trial is designed to compare the efficacy of high
dose long acting risperidone ( 75 mg-100 mg q2 weeks or its equivalent) with standard doses
of long acting risperidone (≤50 mg/q 2weeks) for Total Psychopathology, positive, negative,
and depressive symptoms, and cognition in patients who are considered to be poor responders
by themselves, significant others, or clinicians. This will include two types of
inadequately responding patients—those who are treatment resistant by research criteria
(Kane et al., 1988) and those with inadequate response

Inclusion Criteria:

- Patients diagnosed with schizophrenia or schizoaffective disorder

- Able to give written informed consent.

- Moderate psychosis persists although compliant with medication

- Patients must have an inadequate response to two antipsychotic medications (can be
risperidone, oral or long acting - but not required), at doses that are within the
upper end of the standard dosage range

- Patients must have a Clinical Global Impression - Severity (CGI-S) scale score at
screening of at least moderate severity and a PSP score of 60 or below.

- At the time of screening, eligible patients will be receiving or have received
treatment with risperidone oral or Consta, or a combination that does not exceed 50
mg q 2 weeks of Consta or oral risperidone 8 mg/day for at least 6 weeks within seven
years of study entry without satisfactory response as documented in the medical
record Risperidone

- Patients who have received Consta injectable medication within the specified dose
range for no more than a month prior to the onset of the study will be eligible.
Patients receiving mood stabilizers or antidepressants, or both, in addition to
risperidone oral or Consta, will be eligible

- Patients may initially be inpatients or outpatients

- Females of child bearing potential will be admitted only if they are on stable birth
control medication and understand that they should not get pregnant during the course
of the study.

- All patients must have stable housing at the current time or plans for housing
following hospital discharge, if an inpatient.

- Patients must be willing to receive injectable medication

Exclusion Criteria:

- Patients with a diagnosis other than schizophrenia or schizoaffective disorder.

- Patients previously treated with doses of these agents higher than those allowed for
at least six months and who failed to have an adequate response will be excluded

- Patients currently taking clozapine or have failed an adequate trial of clozapine
which lasted at least 3 months

- Pregnant females. Females who are currently breastfeeding will be excluded.

- Patients with a diagnosis of substance dependence at screening or up to one year
prior to enrollment.

- Patient with worse than mild tardive dyskinesia or history of marked EPS at screening

- Patients who have had neuroleptic malignant syndrome

- Patients with a history of galactorrhea

- Patients with uncontrolled medical condition(s)

- Patients with a history of non-compliance to oral or injectable medication.

- Patients unwilling to have injectable medication