Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00299702
Status:
COMPLETED
Last Update Posted:
2011-12-30
First Post:
2006-03-03
Brief Title:
Evaluation of Effectiveness of Risperdal Consta Compared to Abilify Over a Two-year Period in Patients With Schizophrenia
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2011-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 investigators 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 patients 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 doctors 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 patients 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 25 375 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RISSCH4060 | OTHER | Johnson Johnson Pharmaceutical Research and Development LLC | None |