CONCERTA® (Methylphenidate Hydrochloride) as add-on Therapy in the Treatment of Adult Major Depressive Disorder.
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): methylphenidate
Intervention type(s): Drug
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: methylphenidate hydrochloride; oral tablets; Major Depressive Disorder