Pragmatic randomized trial of Risperdal Consta versus oral atypical antipsychotics in poorly aderant subjects with schizophrenia ina routine care setting. Protocol RISSCH4055; Phase IV(risperidone microspheres) - Pragmatic randomized trial of Risperdal Consta versus oral atypical antipsychotics

• Conditions: Schizophrenia

• Registration Number: EUCTR2005-004383-23-IE
• Lead Sponsor: Janssen-Cilag Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-20
• Last Update Posted: 18 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

Inclusion Criteria
Subjects must satisfy the following criteria to be enrolled in the study:
1) Male or female inpatient or outpatient subjects, aged 18 65 years inclusive
2) Diagnosis of schizophrenia as per Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text revision (DSM-IV TR)39
3) Female subjects must be surgically sterile, or practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intra-uterine device, double-barrier method, contraceptive patch, male partner sterilisation or abstinence) before entry and throughout the study; and have a negative urine pregnancy test at screening before study entry
4) Subjects who have had at least 2 hospitalizations or ³ 2 clinical exacerbations (as defined in 3.1) over the past 2 years due to suspected deteriorating adherence
5) In the last 5 years, patient must have demonstrated a satisfactory response (minimum of 6 weeks) to oral antipsychotics (excluding clozapine) to confirm no treatment resistance.
6) Currently on antipsychotic treatment as per local product label guidelines.
7) Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
8)Otherwise healthy as confirmed by physical exam, vital signs and laboratory testing.
9)Subject has an address and access to a telephone

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Potential subjects who meet any of the following criteria will be excluded from participating in the study:
1) Primary DSM-IV TR Axis I diagnosis other than schizophrenia
2) Subjects previously treated or currently on clozapine
3) Confirmed hypersensitivity or intolerability to risperidone
4) Contraindications for use as listed in the product monographs for risperidone, olanzapine, quetiapine, and where commercially available aripiprazole and amisulpride
5) Female subjects who are currently pregnant or breastfeeding or planning a pregnancy within 2 years of trial start
6) Long acting formulations of neuroleptic medications within 1 treatment cycle of screening
7) Subjects who have failed to respond to 2 or more adequate treatment trials of antipsychotics (an adequate trial is defined as 6 weeks of treatment on the maximum local label dose of the antipsychotic) or 1 adequate trial with oral risperidone.
8) Laboratory abnormality that is deemed clinically significant by the Investigator
9) Serious, unstable and untreated medical illnesses: vascular or cardiovascular disease, history of liver or renal insufficiency, significant cardiac, pulmonary, gastrointestinal, endocrine, neurological or metabolic disturbances
10) Subjects at significant risk of suicide or violence at study start
11) Evidence of alcohol or medication abuse or dependence (except for nicotine and caffeine dependence) according to DSM-IV TR criteria diagnosed in the last month prior to entry
12) Treatment with electroconvulsive therapy (ECT) within 2 years of screening
13) Have received an experimental medication or used an experimental medical device within 30 days before screening.
14) Employees of the investigator or study centre, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified