Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00391222
Status:
COMPLETED
Last Update Posted:
2014-05-09
First Post:
2006-10-20
Brief Title:
A Study to Evaluate the Efficacy and Safety of Risperidone for the Prevention of Mood Episodes in the Treatment of Patients With Bipolar I Disorder
Sponsor:
Janssen Pharmaceutica NV Belgium
Organization:
Janssen Pharmaceutica NV Belgium
Study Overview
Official Title:
A Randomized Double Blind Placebo and Active Controlled Parallel Group Study to Evaluate the Efficacy and Safety of Risperidone Long-acting Injectable LAI for the Prevention of Mood Episodes in the Treatment of Subjects With Bipolar I Disorder
Status:
COMPLETED
Status Verified Date:
2014-04
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 randomized double blind double dummy multicenter study was to evaluate the efficacy of risperidone long-acting injectable LAI monotherapy in comparison with placebo in the prevention of a mood episode in treatment of patients with bipolar I disorder Oral olanzapine was used to assess the validity of the study design The primary objective of this study is to evaluate the efficacy of risperidone LAI versus placebo in the prevention of a mood episode recurrence event in patients with bipolar I disorder after a 12-week 3 month stabilization period on risperidone LAI as measured by the time to recurrence of any mood episode Risperidone LAI has been approved by the FDA in the USA for the treatment of patients with schizophrenia and for the prevention of mood recurrences in bipolar I disorder as monotherapy or add-on treatment It is approved at EMEA and other European and non-European health authorities for the treatment of patients with schizophrenia too
Detailed Description:
This is a randomized double-blind double-dummy multicenter study with 3 parallel arms risperidone long-acting injectable LAI placebo and olanzapine to evaluate the efficacy and safety of risperidone LAI versus placebo in the prevention of a mood episode recurrence event The primary objective of this study is to evaluate the efficacy of risperidone LAI monotherapy versus placebo in the prevention of a mood episode recurrence event in patients with bipolar I disorder after a 12-week 3 month stabilization period on risperidone LAI as measured by the time to recurrence of any mood episode This study includes 3 periods - the screening period Period I lasting up to 2 weeks the open-label treatment period Period II lasting 12 weeks and the double-blind treatment period Period III lasting up to 18 months and at least 9 months In the open -label treatment period Period II treatment with risperidone LAI will be started with injection of a recommended dose of 25 mg every 14 days in patients entering Period II If judged clinically appropriate patients may start with 375 mg every 14 days Dosage can only be increased up to a maximum dose of 50 mg every 14 days if the Clinical Global Impression - Severity CGI-S score has increased by 1 over 2 consecutive assessments at least 2 weeks apart and if there is symptom exacerbation that cannot be treated adequately with short-term 14 days benzodiazepine medication If an increase in risperidone LAI dosage is necessary oral risperidone 1 to 2 mgday needs to be added for 3 weeks after the first injection of the higher dosage Washout of all psychotropics other than risperidone long acting must be completed by the end of the first week Non-acute patients on an antipsychotic or mood stabilizer for at least 4 weeks will continue their previous treatment for the first 3 weeks No changes will be made in the regimens of non-acute patients receiving an antipsychotic or mood stabilizer unless there is concern about efficacy or safetyPatients experiencing an acute manic or mixed episode will additionally be treated with oral risperidone at whole-milligram dosages between 1 and 6 mgday as needed to treat the symptoms of the acute episode for the first 3 weeks in order to cover the 3 weeks lag period of Risperidone long acting Patients experiencing an acute episode who do not respond to treatment within 4 weeks will be discontinued from the study Patients who do not show a response acute patients at baseline or do not maintain the efficacy non-acute patients at baseline and acute patients after initial response during the 12-week 3 month open-label risperidone LAI stabilization period Period II will be discontinued from the study as soon as any one of the following criteria is met The patient meets Diagnostic and Statistical Manual of Mental Disorders 4th Edition text revised DSM-IV-TR criteria for a hypomanic manic mixed or depressive episode the patient needs treatment intervention with any mood stabilizer antipsychotic medication other than study drug benzodiazepine beyond the dosage allowed or antidepressant medication the patient requires hospitalization for any bipolar mood episode the patient either has a Young Mania Rating Scale YMRS score 12 in combination with CGI-S score 4 or a Montgomery-Åsberg Depression Rating Scale MADRS score 12 in combination with a CGI-S score 4 If either of these criteria is fulfilled at an assessment but if the investigator assumes that this is only a temporary state that requires no action the investigator is allowed to postpone the decision about maintenance or response by a maximum of 4 days If after 4 days the criteria are still met the patient must be withdrawn from Period II Patients who show initial and maintained response acute patients at baseline or who maintain the efficacy non-acute patients at baseline during the 12-week 3-month open-label risperidone LAI stabilization period Period II will be eligible for entering the double-blind treatment period Period III Patients who enter Period III will be randomized to receive intramuscular injections of risperidone LAI every 14 days at the dosage achieved at the end of Period II and oral placebo daily or placebo injections every 14 days and oral placebo daily or placebo injections every 14 days and oral olanzapine 10 mgday No supplementation with oral risperidone and no dosage titration will be allowed during this period of the study Using the double-dummy design all patients will receive an intramuscular injection every 14 days and will take oral medication every day Patients who present with a recurrence during Period III will be considered as meeting the end point of the study Patients will remain in the double-blind treatment period until they meet recurrence criteria until they withdraw consent or are lost to follow-up until the last patient completed at least 9 months without a mood episode in Period III or until the study ends The study will end when 158 patients have presented with a mood episode in Period III or if the study is terminated based on the decision of the sponsor Approximately 860 patients meeting the inclusion and exclusion criteria will be enrolled in this study with the goal of observing at least 158 recurrence events in Period III Safety evaluations will include adverse events clinical laboratory tests - including blood glucoselipid profile fasting prolactin TSH and urinalysis - vital signs pulse and blood pressure and ECG physical examination body weight and height the Extrapyramidal Symptom Rating Scale pregnancy testing and urine drug screen The patients will receive risperidone LAI 25 375 or 50 mg period II every 14 days during the 12 week long open-label period Period II Patients who enter the double-blind period Period III will be randomized to receive intramuscular injections of risperidone LAI every 14 days and oral placebo daily or placebo injections every 14 days and oral placebo daily or placebo injections every 14 days and oral olanzapine 10 mgday
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