Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00094926
Status:
COMPLETED
Last Update Posted:
2011-05-19
First Post:
2004-10-28
Brief Title:
A Study of Effectiveness and Safety of Risperdal CONSTA Added to Usual Treatment in Patients With Bipolar Disorder Who Have Frequent Mood Episodes
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Prospective Randomized Double-blind Placebo-controlled Study of the Effectiveness and Safety of RISPERDAL CONSTA Augmentation in Adult Patients With Frequently-relapsing Bipolar Disorder
Status:
COMPLETED
Status Verified Date:
2010-04
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 examine the safety and effectiveness of the long acting injectable form of the atypical antipsychotic Risperidone Risperdal CONSTA along with treatment as usual TAU in bipolar disorder patients who had more than 4 mood episodes in the past year
Detailed Description:
Frequently-relapsing more than 4 episodes in the last year bipolar patients are a sub-group of patients who have multiple mood episodes in spite of treatment Currently available treatments may have little impact on number and frequency of manic andor depressed mood episodes and as a result these patients have higher than average rates of illness and death This study examines the effectiveness and side effects of risperidone long-acting injections LAI added to treatment as usual TAU in frequently-relapsing bipolar patients The study has two main phases The first phase is open-label patients and doctors know what medication and dose the patient is receiving- both risperidone LAI and TAU and lasts 16 weeks During that time patients are treated with the goal that they reach remission a predefined level of improvement decrease in number and severity of mood episodes Patients who meet remission criteria at the end of the first phase are randomized like flipping a coin to either continue receiving the same dose of risperidone LAI plus TAU or placebo injections plus TAU Patients continue in the second phase for 52 weeks during which time the effectiveness is measured by time to relapse worsening of mood symptoms severe enough to require hospitalization or a major change in medication Additional effectiveness safety and side effect measures are evaluated throughout the length of the study
Long-acting risperidone injection 25 mg will be administered every two weeks through a gluteal injection for at least one month Thereafter the dose may be increased to 375mg then to 50 mg based on clinical response and tolerability Supplemental use of oral Risperdal 1 to 2 mgday will be permitted during the first 12 weeks of the Open-Label Stabilization Phase Patients must be taking a stable dose of risperidone LAI for the 4 weeks immediately prior to entering the Double-Blind Phase
Long-acting risperidone injection 25 mg will be administered every two weeks through a gluteal injection for at least one month Thereafter the dose may be increased to 375mg then to 50 mg based on clinical response and tolerability Supplemental use of oral Risperdal 1 to 2 mgday will be permitted during the first 12 weeks of the Open-Label Stabilization Phase Patients must be taking a stable dose of risperidone LAI for the 4 weeks immediately prior to entering the Double-Blind Phase
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 |
|---|---|---|---|
| RISBIP302 | None | None | None |