Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00250367
Status:
COMPLETED
Last Update Posted:
2010-11-25
First Post:
2005-11-04
Brief Title:
A Study of the Effectiveness and Safety of Risperidone Versus Placebo as add-on Therapy to Mood Stabilizers in the Treatment of Manic Episodes Associated With Bipolar Disorder
Sponsor:
Janssen Pharmaceutica NV Belgium
Organization:
Janssen Pharmaceutica NV Belgium
Study Overview
Official Title:
The Safety And Efficacy Of Risperdal Risperidone Versus Placebo As Add-On Therapy To Mood Stabilizers In The Treatment Of The Manic Phase Of Bipolar Disorder
Status:
COMPLETED
Status Verified Date:
2010-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to evaluate the effectiveness and safety of risperidone an antipsychotic medication versus placebo as add-on therapy to mood stabilizers in the treatment of manic episodes associated with bipolar disorder
Detailed Description:
Risperidone widely used in the treatment of schizophrenia has been shown to be effective in the treatment of manic and mixed episodes associated with bipolar disorders Antipsychotic drugs like risperidone have also been used as therapeutic agents in the treatment of patients who are not responsive to mood stabilizers alone This is a randomized double-blind study to evaluate the effectiveness and safety of risperidone compared with placebo as an addition to mood stabilizing drugs in the treatment of patients experiencing manic episodes associated with bipolar disorder The study has two phases a double-blind treatment phase 3 weeks and an open-label phase 10 weeks To participate in the study patients must be in-patients for a minimum of the first 4 days of double-blind treatment During the double-blind treatment phase patients receive risperidone or placebo tablets to be taken once a day at gradually increasing doses at investigators discretion up to a maximum dose of 6 mgday while continuing their treatment with a mood stabilizer lithium valproate or carbamazepine In the open-label phase therapy with a mood stabilizer continues and all patients receive risperidone with dosage gradually adjusted to achieve optimal effectiveness The primary measure of effectiveness is the change in Young Mania Rating Scale YMRS total score from baseline to end of double-blind treatment Additional efficacy measures include the Brief Psychiatric Rating Scale BPRS the Clinical Global Impression CGI which evaluates the change in severity of the disorder and the Hamilton Depression Rating Scale HAMD Safety assessments include the incidence of adverse events throughout the study measurement of vital signs pulse and blood pressure and evaluation of the presence and severity of extrapyramidal symptoms by the Extrapyramidal Symptom Rating Scale ESRS at specified intervals and clinical laboratory tests hematology biochemistry urinalysis before study initiation at completion of the double-blind treatment and at the end of the study The study hypothesis is that daily treatment with risperidone as add-on therapy provides better effectiveness than the addition of placebo as measured by Young Mania Rating Scale scores in the treatment of the manic phase of bipolar disorder Risperidone 1 mg tablets taken orally once daily Doses of 2 mg on Days 1 and 2 up to 4 mg on Days 3 and 4 and up to 6 mg maximum dose on Days 5 through 21 Same dose maintained through the 10 week open-label phase Gradual dose adjustments are allowed to achieve optimal effectiveness
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