Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00044681
Status:
COMPLETED
Last Update Posted:
2011-05-18
First Post:
2002-09-03
Brief Title:
A Study of the Effectiveness and Safety of Risperidone to Augment SSRI Therapy in Patients With Treatment-resistant Depression
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Study to Evaluate the Efficacy Safety and Maintenance Effect of Risperidone Augmentation of SSRI Monotherapy in Young and Older Adult Patients With Unipolar Treatment-Resistant Depression
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 this study is to evaluate the effectiveness and safety of risperidone to augment SSRI therapy in patients with treatment-resistant depression and to demonstrate the long-term maintenance effect of risperidone as augmentation therapy compared with placebo augmentation in these patients
Detailed Description:
Treatment strategies for treatment-resistant depression TRD involve either switching to another antidepressant augmenting the first-line treatment with various pharmacologic agents or switching to a different medication in combination with another agent This study includes 2 phases an open-label treatment phase and a double-blind maintenance phase during which neither the patient nor the physician knows whether risperidone or placebo is administered The open-label phase has an initial period of 6 weeks during which patients with TRD receive only citalopram a selective serotonin reuptake inhibitor SSRI Risperidone is then added to the treatment regimen for 4 weeks to evaluate its short-term effect in augmenting the therapy The double-blind phase last for 6 months and evaluates the relapse prevention of continued risperidone augmentation therapy compared with placebo augmentation of the SSRI Targeted daily doses of citalopram and risperidone are adjusted for younger adults 18 to 54 years of age and older adults 55 to 85 years of age Assessments of effectiveness include the Montgomery-Asberg Depression Rating Scale MADRS Hamilton Rating Scale of Depression HAM-D Clinical Global Impression of Severity CGI-S response rate determined by the proportion of patients showing 50 improvement on MADRS total score and relapse evaluated by changes in CGI or HAM-D scores Safety evaluations include the incidence of adverse events throughout the study vital signs pulse and blood pressure and weight and clinical laboratory tests hematology biochemistry urinalysis at specified intervals The study hypothesis is that risperidone augmentation of SSRI therapy will show significant improvement in symptoms of depression compared with SSRI monotherapy and that risperidone augmentation will show better time-to-relapse than placebo augmentation in patients with TRD Once daily oral tablets of risperidone 025 milligrammg 05mg 10mg and 20mg citalopram 20mg and 40mg or placebo Risperidone for 30 weeks 025-20mg for younger adults 025-10mg for older adults Citalopram for 36 weeks 20-60 mg for younger adults 20-40 mg for older adults
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