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

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ClinicalTrials.gov Identifier: NCT00246233
Recruitment Status : Completed
First Posted : October 31, 2005
Last Update Posted : May 17, 2011
Sponsor:
Information provided by:
Janssen-Ortho Inc., Canada

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.

Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Drug: methylphenidate Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 145 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled, Randomized Trial to Evaluate the Safety, Tolerability and Efficacy of CONCERTA® (Methylphenidate Hydrochloride) Augmentation of SSRI/SNRI Monotherapy in Adult Patients With Major Depressive Disorder.
Study Start Date : June 2005
Actual Study Completion Date : April 2006

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Change in total Montgomery Asberg Depression Rating Scale (MADRS) score between the two groups from baseline to the final visit.

Secondary Outcome Measures :
  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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00246233


Sponsors and Collaborators
Janssen-Ortho Inc., Canada
Investigators
Study Director: Janssen-Ortho Inc. Clinical Trial Janssen-Ortho Inc., Canada

Additional Information:
Publications of Results:
ClinicalTrials.gov Identifier: NCT00246233     History of Changes
Other Study ID Numbers: CR006073
First Posted: October 31, 2005    Key Record Dates
Last Update Posted: May 17, 2011
Last Verified: April 2010

Keywords provided by Janssen-Ortho Inc., Canada:
methylphenidate hydrochloride
oral tablets
Major Depressive Disorder

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents