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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

Sponsored by Janssen-Cilag International NV

About this trial

Last updated 11 years ago

Study ID

CR002269

Status

Completed

Type

Interventional

Phase

Phase 3

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 18 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

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)

No

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

Locations

Location

Status