Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00095134
Status:
COMPLETED
Last Update Posted:
2011-12-06
First Post:
2004-11-01
Brief Title:
Study Comparing Adjunctive Risperidone Versus Placebo in Major Depressive Disorder That Is Not Responding to Standard Therapy
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Double-Blind Study Comparing Adjunctive Risperidone Versus Placebo in Major Depressive Disorder That Is Not Responding to Standard Therapy
Status:
COMPLETED
Status Verified Date:
2011-12
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 this trial is to evaluate the efficacy and safety of risperidone versus placebo in subjects with Major Depressive Disorder with sub-optimal response to antidepressant therapy
Detailed Description:
Many patients who suffer from Major Depressive Disorder MDD do not benefit or show only partial benefit from current psychotropic therapy This clinical trial seeks to study the efficacy and safety of adjunctive treatment with risperidone in patients with MDD who failed to adequately respond to standard antidepressant treatment prior to this trial and who prospectively do not respond to adequate treatment with standard antidepressant therapy SAD
Patients entering the open label phase of the study will have already taken a commercially available SAD for a minimum of 4 weeks and provided the dose was optimal will continue on this dose of SAD throughout the four-week open-label and six-week double-blind phases of the trial
If the dose in the four weeks prior to entering the study was not optimal as per standard clinical practice the dose will be increased to be within the optimal range and continued at that dose through the entire open-label SAD and double-blind phases
During the double-blind phase subjects receive an adjunctive dose of risperidone or placebo once daily added to their stable dose of SAD The starting dose of risperidone or placebo is 025 mg for the first three days of the double-blind phase and is increased to 05 mg for days 4 through 14 On the 15th day of this phase the dose is increased to the target dose of 10 mgday If response to this dose is not optimal by day 29 it is increased to 20 mgday and is maintained for the duration of the 6-week double-blind phase This dose may be reduced once to 10 mgday but then must be maintained at that dose for the remainder of the study
Patients entering the open label phase of the study will have already taken a commercially available SAD for a minimum of 4 weeks and provided the dose was optimal will continue on this dose of SAD throughout the four-week open-label and six-week double-blind phases of the trial
If the dose in the four weeks prior to entering the study was not optimal as per standard clinical practice the dose will be increased to be within the optimal range and continued at that dose through the entire open-label SAD and double-blind phases
During the double-blind phase subjects receive an adjunctive dose of risperidone or placebo once daily added to their stable dose of SAD The starting dose of risperidone or placebo is 025 mg for the first three days of the double-blind phase and is increased to 05 mg for days 4 through 14 On the 15th day of this phase the dose is increased to the target dose of 10 mgday If response to this dose is not optimal by day 29 it is increased to 20 mgday and is maintained for the duration of the 6-week double-blind phase This dose may be reduced once to 10 mgday but then must be maintained at that dose for the remainder of the study
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