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.

Official 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

Study Type

Interventional

Study Design

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Further Details

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

Click here to watch Professor Keks talk about effective schizophrenia treatments.

Study Start

December 2005

Eligibility & Criteria

• 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

Total Enrolment

260

Contact Details

• Dandenong, 3175, Australia; Recruiting
• Frankston, 3199, Australia; Recruiting
• Mt Claremont, 6010, Australia; Recruiting
• Newcastle, 2300, Australia; Recruiting
• Southport, 4215, Australia; Recruiting

To learn how to participate, click here