A Study of Risperidone Long-Acting Injection Versus Oral Antipsychotics in Schizophrenia Patients With a History of Being Poorly Compliant With Taking Their Medication

The purpose of this study is to evaluate risperidone long-acting injection (an antipsychotic medication) versus oral antipsychotics in schizophrenia patients with a history of being poorly compliant with taking their medication.

[title]Pragmatic Randomized Trial of 'Risperdal CONSTA' (Risperidone) Versus Oral Atypical Antipsychotics in Poorly Adherent Subjects With Schizophrenia in a Routine Care Setting. [conditions]Schizophrenia [studytype]Interventional[studydesign]Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study [studydetails]Primary Outcome Measures:

The proportion of subjects experiencing a clinical intensification of schizophrenia symptoms after being in the study for 3 months.

Secondary Outcome Measures:

PANSS, CGI-S and CGI-C, RUQ, AQoL, PSP, evaluation of symptomatic remission over time, proportion of clinical intensification of symptoms during the trial, time to intensification of symptoms and the number of incidences of intensification of symptoms

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[studystart]December 2005[eligibility]

Ages Eligible for Study: 18 Years - 65 Years
Genders Eligible for Study: Both

Inclusion Criteria:

Diagnosis of schizophrenia as per DSM-IV
Have had at least 2 hospitalizations or 2 clinical worsening of symptoms over the past 2 years due the patient suspected of being poorly compliant with taking their medication
Is currently receiving treatment with an antipsychotic per local labeling, and has a history in the last 5 years of a satisfactory response (minimum of 6 weeks) to oral antipsychotics (excluding clozapine)
Otherwise healthy, as confirmed by physical exam, vital signs, and laboratory testing: female subjects must be surgically sterile, or practicing an effective method of birth control before entry and throughout the study, and have a negative urine pregnancy test at screening before study entry

Exclusion Criteria:

Subjects with a primary DSM-IV TR Axis I diagnosis other than schizophrenia
Previously treated or currently on clozapine
Have a serious, unstable and untreated medical illnesses, such as vascular or cardiovascular disease, history of liver or kidney disease, significant cardiac, pulmonary, gastrointestinal, endocrine, neurological or metabolic disturbances
At significant risk of suicide or violence at study start
Evidence of alcohol or medication abuse or dependence

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