Official Title: “Switching From Risperidone to Paliperidone ER in Stable But Symptomatic Outpatients With Schizophrenia: Patient's Satisfaction and Quality of Life”

The purpose of this study is explore the effectiveness, based on total Positive and Negative Syndrome Scale (PANSS) score, of flexibly dosed paliperidone ER in patients with schizophrenia previously unsuccessfully treated with risperidone. Treated without success means: adequate risperidone dose during a reasonable period without success due to the main following reasons: lack of effectiveness of the previous treatment; lack of tolerability or safety with the previous treatment.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Schizophrenia is a chronic debilitating illness that affects approximately 1% of the world's population. It is characterized by various symptoms including delusions, hallucinations, agitation, hostility, emotional and social withdrawal, lack of spontaneity and poverty of speech. Effective therapies for schizophrenia need to be highly efficacious without sacrificing tolerability. Stable outpatients with residual symptoms or distressing side effects are much more likely to try changing their antipsychotic medications seeking better outcomes beyond relapse prevention. The indications for switching antipsychotic medication include a poor therapeutic response and persistent symptoms. Although changing antipsychotic medication should be considered for patients who are inadequately treated, several aspects must be taken into account, namely psychosis may deteriorate or relapse due to insufficient drug effect, symptoms due to sudden discontinuation of current antipsychotic treatment (psychotic and extrapyramidal symptoms and/or autonomic and behavioral disturbances), worsening of side effects due to addition of a new drug to the ongoing treatment, compliance impairment due to complicated switch procedures. Paliperidone is a new medication.

Paliperidone is available in a formulation using extended release (ER) osmotic release technology (OROS) paliperidone, referred to as paliperidone ER. This formulation has been designed to deliver paliperidone at a relatively controlled rate over a 24-hour period, resulting in a gradual increase in plasma concentration after the first intake and a low fluctuation of concentration at steady state. It has been shown that with this pharmacokinetic profile, most patients are able to start with an effective antipsychotic dosage without limiting side effects (e.g., postural hypotension). This open label (all people involved know the identity of the intervention) study will explore the tolerability, safety and effectiveness of flexibly dosed paliperidone ER in patients with schizophrenia previously treated with risperidone with poor response. Patients with receive an oral daily dose of medication in flexible dosage (3mg, 6mg, 9mg or 12mg) according to investigator decision. Patients will receive an oral daily dose of medication in flexible dosage (3mg, 6mg, 9mg or 12mg) according to investigator decision. Oral tablets contain 3mg, 6mg or 9mg of paliperidone.

Intervention(s) in this Clinical Trial

• Drug: paliperidone
  • Oral daily dose 3mg, 6mg, 9mg or 12mg according to investator decision

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 001

Primary Measures

• To explore the effectiveness, based on total Positive and Negative Syndrome Scale (PANSS) score, of flexibly dosed paliperidone ER in patients with schizophrenia previously unsuccessfully treated with risperidone.
  • Time Frame: 12 months
    Safety Issue?: No

Secondary Measures

• To explore the tolerability and safety of flexibly dosed paliperidone ER in patients with schizophrenia previously unsuccessfully treated with a risperidone
  • Time Frame: 12 months
    Safety Issue?: Yes
• To explore the characteristics of response of the transition from previous risperidone to flexibly dosed paliperidone ER. This will be done by assessing study scales
  • Time Frame: 12 months
    Safety Issue?: No

Inclusion Criteria:

• Female patients must be postmenopausal for at least 6 months, surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study and have a negative serum b hCG pregnancy test at screening
• Previous diagnosis of schizophrenia according to DSM-IV
• Baseline PANSS score > 78
• Oral monotherapy with risperidone in a regimen within the daily dosage recommended by the package insert
• Adherence to the prescribed risperidone regimen for at least 30 days prior to study admission
• Partial response to the current risperidone regimen (persistent symptoms or unstable clinical condition) or presence of unbearable side effects
• Potential candidates for switching to another atypical antipsychotic due to their clinical response and/or side effects profile
• Subjects must have signed an informed consent document

Exclusion Criteria:

• Prior or concomitant psychiatric disease other than schizophrenia by DSM-IV
• Concomitant severe medical or neurological disorder
• Previous use of clozapine
• History of previous non-responsiveness to oral antipsychotic treatment
• Risk of suicide
• Have received an experimental drug or used an experimental medical device within 30 days before the planned start of treatment
• Pregnant or breast-feeding

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Janssen-Cilag Farmaceutica Ltda.

Overall Clinical Trial Officials and Contacts

Janssen-Cilag Farmaceutica Ltda. Clinical Trial Study Director Janssen-Cilag Farmaceutica Ltda.  

Information obtained from ClinicalTrials.gov on February 04, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01010776

Study ID Number: CR013744

ClinicalTrials.gov Identifier: NCT01010776

Health Authority: Brazil: National Health Surveillance Agency