Official Title: “A 2-Year, Prospective, Blinded-Rater, Open-Label, Active-Controlled, Multicenter, Randomized Study of Long-Term Efficacy and Effectiveness Comparing Risperdal® Consta® and Abilify® (Aripiprazole) in Adults With Schizophrenia”

The purpose of this study is to compare the effectiveness of two antipsychotic medications, Risperdal® Consta® versus Abilify®, over a 2-year treatment period in the long-term maintenance of patients with schizophrenia.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: January 2009

Although many patients with schizophrenia currently take oral antipsychotic medications, it is estimated that up to 75% of them have difficulty adhering to the daily oral regimen.

Long-acting injectable formulations of antipsychotics may eliminate the need for daily medication and enhance patient compliance with the treatment regimen. The purpose of this trial is to evaluate the long-term effectiveness of Risperdal® Consta®, a long-acting injectable antipsychotic medication, versus Abilify®, an oral antipsychotic medication in patients with schizophrenia. The study will include patients, who in the investigator's opinion may benefit from a change in their current antipsychotic medication due to insufficient effectiveness, side effects or difficulty in adhering to a daily dose regimen.

This is an open-label, randomized study in which patients will have an equal chance of receiving treatment for up to 2 years with Risperdal® Consta®, administered in the muscles near the hip every 2 weeks, or Abilify®, taken orally once daily. The initial dose and subsequent dose of study drug will be determined by the investigator. The patient's current oral antipsychotic medication will be decreased over the first four weeks of the study and discontinued. During the study, investigators may adjust the dose of study drug or add new antipsychotic medications to treat worsening psychotic symptoms. Patients may continue on or have added, antidepressants, mood stabilizers (except carbamazepine), sedative hypnotics, or anxiolytic medications during the study. Patients will return to the doctor's office every two weeks to receive an injection of Risperdal® Consta® or another supply of Abilify®.

During certain visits, patients will be asked questions which will help the investigator determine the severity of the patient's illness, how well the study drug is working, quality of life, reasoning, memory, judgement and perception and side effects that may be associated with schizophrenia or treatment. Safety evaluations include the incidence of adverse events during the study, vital signs and clinical laboratory tests (both blood and urine). The study hypothesis is that Risperdal® Consta® is superior to Abilify® in the long-term treatment of subjects with schizophrenia as measured by time to relapse and time in remission.

Treatment with Risperdal® Consta® (administered in the muscle every 2 weeks) at a dose of 25, 37.5 or 50 mg or Abilify® (administered orally daily) at a dose of 10-30 mg for 2 years.

Investigators will determine the starting dose and may adjust the dosage of study drug during the study according to symptoms and treatment response.

Intervention(s) in this Clinical Trial

• Drug: Long-acting risperidone injectable; aripiprazole oral tablets

Primary Measures

• The primary objectives of this trial are to: 1) compare the effectiveness of Risperdal Consta to Abilify in preventing relapse in subjects with schizophrenia; and 2) compare the effectiveness of Risperdal Consta to Abilify using time in remission.

Secondary Measures

• The secondary objectives of the trial are to compare the effectiveness of Risperdal Consta to that of Abilify, as assessed by time to remission, as well as safety/tolerability, subject impact, and social impact.

Inclusion Criteria:

• Patients with diagnosis of schizophrenia
• Patient has had at least 2 psychotic relapses in the two years prior to study entry
• Patient is not adequately benefiting from their current antipsychotic medication

Exclusion Criteria:

• Patients that have been hospitalized or had major medication changes within 2 months of study entry
• Patients currently experiencing, or who have experienced worsening of disease symptoms within 2 months of study entry
• Patients currently using clozapine or carbamazepine
• Patients who have undergone electroconvulsive therapy or depot antipsychotic treatment within 6 months prior to study entry
• 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: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Overall Clinical Trial Officials and Contacts

Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial Study Director Johnson & Johnson Pharmaceutical Research & Development, L.L.C.  

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00299702

Study ID Number: CR006121

ClinicalTrials.gov Identifier: NCT00299702

Health Authority: United States: Food and Drug Administration