Overview

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

Status:
Completed
Trial end date:
2007-11-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Janssen-Cilag International NV
Treatments:
Aripiprazole
Quetiapine Fumarate
Risperidone
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