Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00132678
Status:
COMPLETED
Last Update Posted:
2013-07-29
First Post:
2005-06-30
Brief Title:
A Study of the Safety and Efficacy of Injectable Risperidone in the Prevention of Bipolar Mood Episodes
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Study to Explore the Efficacy and Safety of Risperidone Long-acting Intramuscular Injectable in the Prevention of Mood Episodes in Bipolar 1 Disorder With Open-label Extension
Status:
COMPLETED
Status Verified Date:
2013-07
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 determine if risperidone is effective and safe in the prevention of mood episodes in patients with bipolar 1 disorder
Detailed Description:
RISPERDAL CONSTA risperidone long-acting injection may provide substantial improvement by reducing patient non-compliance in the long-term treatment of bipolar I disorder This is a randomized patients are assigned different treatments based on chance double-blind neither the patient nor the physician knows whether drug or placebo is being taken or at what dosage placebo-controlled study to explore the safety and effectiveness of RISPERDAL CONSTA in the prevention of mood episodes in patients with bipolar 1 disorder This study includes 5 periods a screening period lasting up to 1 week an open-label RISPERDAL oral risperidone treatment period lasting 3 weeks an open-label RISPERDAL CONSTA stabilization period lasting 26 weeks a double-blind period lasting up to 24 months and an open-label extension with RISPERDAL CONSTA lasting 8 weeks Efficacy will be assessed using the Young Mania Rating Scale YMRS Montgomery-Åsberg Depression Rating Scale MADRS Clinical Global Impressions - Severity CGI-S scale Medical Outcomes Study Short Form 36 SF-36 and the Personal and Social Performance PSP scale Safety will be evaluated throughout the study and includes assessment of adverse events clinical laboratory tests including hematology serum chemistry blood glucoselipid profile prolactin and urinalysis electrocardiograms ECGs vital signs pulse and blood pressure physical examination body mass index BMI and the Extrapyramidal Symptom Rating Scale ESRS Oral risperidone flexible dosage 1 to 6 mgday for the first 3 weeks Risperidone LAI im injections 125mg 25 mg 375 mg or 50 mg given every 2 weeks for up to approximately 26 years only 6 months for patients receiving placebo during DB-period
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 |
|---|---|---|---|
| RISBIM3003 | None | None | None |