Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00246233
Status:
COMPLETED
Last Update Posted:
2011-05-17
First Post:
2005-10-28
Brief Title:
CONCERTA Methylphenidate Hydrochloride as add-on Therapy in the Treatment of Adult Major Depressive Disorder
Sponsor:
Janssen-Ortho Inc Canada
Organization:
Janssen-Ortho Inc Canada
Study Overview
Official Title:
A Double-blind Placebo-controlled Randomized Trial to Evaluate the Safety Tolerability and Efficacy of CONCERTA Methylphenidate Hydrochloride Augmentation of SSRISNRI Monotherapy in Adult Patients With Major Depressive Disorder
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
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 effects of the addition of CONCERTA methylphenidate hydrochloride a central nervous system CNS stimulant or placebo in adult outpatients with Major Depressive Disorder who are currently being treated with oral antidepressant medication selective serotonin reuptake inhibitors or selective norepinephine reuptake inhibitors The general symptoms of depression will be evaluated as measured by the Montgomery Asberg Depression Rating Score MADRS on fatigue energy and overall severity of illness The safety and tolerability of the CONCERTA and antidepressant combination therapy will also be assessed
Detailed Description:
Patient response to antidepressant therapy is low and 10-30 of depressed patients fail to respond to antidepressant therapy and of those patients who do respond 50-75 exhibit a partial response Augmentation and combination therapy strategies have been used in depressed subjects to enhance antidepressant response in treatment-resistant patients to achieve remission in partial responders and to accelerate response Augmentation of an antidepressant with CONCERTA is an area open to new exploration in the adult population This is a randomised double-blind placebo-controlled parallel group multicentre trial Qualified subjects will have a diagnosis of Major Depressive Disorder currently treated with an antidepressant and will have demonstrated an insufficient treatment response to at least one but not more than three antidepressants Subjects will continue their current treatment with oral antidepressant medication selective serotonin reuptake inhibitors or selective norepinephine reuptake inhibitors and be randomised to either CONCERTA 18 mg or placebo During the titration phase subjects will take one tablet for the first 5 days and then be titrated up to the next dose level every week 2 tablets then 3 tablets At Week 4 and Week 5 subjects should be at their optimal stable dose of the study drug The maximum dose level is CONCERTA 54 mg or placebo 3 tablets Following titration there are 5 weeks of treatment The primary efficacy outcome is the change in total Montgomery Asberg Depression Rating Scale MADRS score between the two groups from baseline to the final visit MADRS is a clinician-rated scale consisting of 10 items designed to assess a range of depressive symptoms Safety and tolerability of study drug will be based on adverse events and clinical laboratory tests ECG vital signs and physical examination The study hypothesis is that when CONCERTA is added to antidepressant therapy there will be a rapid tolerable and overall improvement in symptoms of depression as measured by the total Montgomery Asberg Depression Rating Score MADRS
Subjects will be randomized to a once-daily starting dose of 18mg CONCERTA or 1 tablet of placebo to be taken orally Provided patients are tolerating the study medication they will be titrated weekly There are 3 weeks of titration and one dose reduction allowed The maximum dose level is 54 mg per day 3 tablets By week 4 and week 5 subjects should be at their optimal dose Following titration there are 5 weeks of treatment
Subjects will be randomized to a once-daily starting dose of 18mg CONCERTA or 1 tablet of placebo to be taken orally Provided patients are tolerating the study medication they will be titrated weekly There are 3 weeks of titration and one dose reduction allowed The maximum dose level is 54 mg per day 3 tablets By week 4 and week 5 subjects should be at their optimal dose Following titration there are 5 weeks of treatment
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