Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00249236
Status:
COMPLETED
Last Update Posted:
2011-01-14
First Post:
2005-11-04
Brief Title:
A Study of the Effectiveness and Safety of Risperidone Versus Placebo in the Treatment of Manic or Mixed Episodes Associated With Bipolar I Disorder
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
The Efficacy And Safety Of Flexible Dosage Ranges Of Risperidone Versus Placebo In The Treatment Of Manic Or Mixed Episodes Associated With Bipolar I 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 assess the effectiveness and safety of risperidone an antipsychotic medication versus placebo in treating mania during 3 weeks of treatment in patients with Bipolar I Disorder who suffer from manic or mixed episodes
Detailed Description:
Antipsychotic agents have for a long time been used to alleviate the severe behavioral problems associated with manic episodes 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 This is a randomized double-blind study to evaluate the effectiveness and safety of risperidone compared with placebo in the treatment of patients with bipolar disorder who are experiencing a manic or mixed episode Patients who are voluntarily hospitalized at the time of study enrollment for treatment of the manic episode receive study medication to be taken orally once a day Patients receive placebo or risperidone at a starting dose of 3 mg with gradual dose increases or decreases at the investigators discretion within the daily dosing range of 1 to 6 mg to achieve optimal effectiveness while minimizing any intolerance to the drug Treatment with risperidone or placebo tablets continues for 3 weeks The primary measure of efficacy is the change from baseline to the end of treatment in the Young Mania Rating Scale YMRS Other efficacy assessments include the changes in the Clinical Global Impression-Severity of Illness CGI-S scale Global Assessment Scale GAS which assesses the patients level of functioning and the Positive and Negative Syndromes Scale PANSS a scale for measuring psychotic symptoms Safety assessments include the incidence of adverse events throughout the study measurement of vital signs temperature pulse 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 at the start and end of the study The study hypothesis is that daily treatment with risperidone is more effective than placebo as measured by Young Mania Rating Scale scores in the treatment of the manic phase of Bipolar I Disorder Risperidone oral tablets 1 mg taken once daily in the evening dose of 3 mg on Day 1 dose range of 2 - 4 mg on Day 2 dose range 1 - 5 mg on Day 3 dose range 1 - 6 mg on Days 4 - 21 Doses may be increased or decreased at investigators discretion
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