Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00253149
Status:
COMPLETED
Last Update Posted:
2011-01-24
First Post:
2005-11-10
Brief Title:
A Study of the Effectiveness and Safety of Risperidone as add-on Therapy to Mood Stabilizers in the Treatment of Manic Episodes Associated With Bipolar Disorder
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
The Safety And Efficacy Of Risperdal Risperidone Versus Placebo Versus Haloperidol As Add-On Therapy To Mood Stabilizers In The Treatment Of The Manic Phase Of Bipolar Disorder
Status:
COMPLETED
Status Verified Date:
2011-01
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 additional therapeutic agents in the treatment of patients who are not responsive to mood stabilizers alone This is a randomized double-blind placebo-controlled 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 Treatment of one group of patients with haloperidol is used as an internal control in the trial The study has two phases a double-blind treatment phase 3 weeks and an open-label phase 10 weeks During the double-blind treatment phase patients receive risperidone haloperidol or placebo tablets to be taken once a day at gradually increasing doses adjusted to 1 to 6 mgday for risperidone and 2 to 12 mgday for haloperidol while continuing treatment with a mood stabilizer lithium or valproate In the open-label phase all patients receive risperidone with the dosage gradually adjusted to achieve optimal effectiveness dose range of 0 to 6 mgday in this phase patients continue therapy with a mood stabilizer lithium valproate or for this phase only carbamazepine The primary measure of effectiveness is the change in the Young Mania Rating Scale YMRS total score from baseline to end of double-blind treatment Additional assessments of effectiveness 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 double-blind treatment and at the end of study The study hypothesis is that daily treatment with risperidone as add-on therapy provides better effectiveness than placebo as measured by Young Mania Rating Scale scores in the treatment of the manic phase of bipolar disorder Double-blind daily doses taken orally once a day - Days 1 and 2 risperidone 2 mg haloperidol 4 mg or placebo Days 3 and 4 risperidone 1 - 4 mg haloperidol 2 - 8 mg or placebo Days 5 - 21 risperidone 1 - 6 mg haloperidol 2 - 21 mg or placebo Open-label risperidone 0 - 6 mgday for 10 weeks
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