CONCERTA® (Methylphenidate Hydrochloride) as add-on Therapy in the Treatment of Adult Major Depressive Disorder.

NCT00246233 | Completed Phase 3

• 1 other identifier: CR006073
• Study Type: interventional
• Target: 145
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Depressive Disorder, Major

Keywords

methylphenidate hydrochloride; oral tablets; Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Change in total Montgomery Asberg Depression Rating Scale (MADRS) score between the two groups from baseline to the final visit.

Secondary Outcomes (1)

• Safety and tolerability of study drug based on adverse events and clinical laboratory tests, ECG, vital signs and physical examination, finding changes from baseline to the final visit.

Interventions

methylphenidate DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen-Ortho Inc., Canada: lead

Related Publications (1)

• Ravindran AV, Kennedy SH, O'Donovan MC, Fallu A, Camacho F, Binder CE. Osmotic-release oral system methylphenidate augmentation of antidepressant monotherapy in major depressive disorder: results of a double-blind, randomized, placebo-controlled trial. J Clin Psychiatry. 2008 Jan;69(1):87-94. doi: 10.4088/jcp.v69n0112.

  PMID: 18312042 RESULT

Related Links

• A double blind, randomized trial to evaluate the safety,tolerability and efficacy of CONCERTA® augmentation of SSRI/SNRI monotherapy in adult patients with Major Depressive Disorder

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Janssen-Ortho Inc. Clinical Trial

  Janssen-Ortho Inc., Canada

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 28, 2005
• First Posted: October 31, 2005
• Study Start: June 1, 2005
• Study Completion: April 1, 2006
• Last Updated: May 17, 2011

Record last verified: 2010-04