Status:
COMPLETED
CONCERTA® (Methylphenidate Hydrochloride) as add-on Therapy in the Treatment of Adult Major Depressive Disorder.
Lead Sponsor:
Janssen-Ortho Inc., Canada
Conditions:
Depressive Disorder, Major
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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 D...
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. Au...
Eligibility Criteria
Inclusion
- Currently having a Major Depressive Disorder episode without psychotic features
- Has had an inadequate response to at least one but not more than 3 antidepressants given for 4 weeks
- Is currently treated with an antidepressant for the past 4 weeks
- Has a Montgomery Asberg Depression Rating Scale (MADRS) total score greater than or equal to 20, lassitude score of greater than or equal to 2 and a suicidal thought score less than 4
- Has a Clinical Global Impression of Severity (CGI-S) score greater than or equal to 4
Exclusion
- Has a current diagnosis of schizophrenia, bipolar disorder, dementia, psychosis, obsessive-compulsive disorder, post-traumatic stress disorder, panic disorder, Attention Deficit Hyperactivity Disorder (ADHD), anorexia nervosa and/or bulimia nervosa, or a history of ADHD, anorexia nervosa and/or bulimia nervosa
- Agitated during the current depressive episode
- Has significant abnormal personality traits, which could interfere with function
- Has a history of substance abuse and or dependence within 6 months prior to screening
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2006
Estimated Enrollment :
145 Patients enrolled
Trial Details
Trial ID
NCT00246233
Start Date
June 1 2005
End Date
April 1 2006
Last Update
May 17 2011
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