Pilot Study of Duloxetine in Adult Attention Deficit Hyperactivity Disorder(ADHD)

Brief Summary

Official Title: “Pilot Study of the Efficacy of Duloxetine in Treating Adults With Attention Deficit Hyperactivity Disorder: a Randomized, Controlled Trial.”

The purpose of this study is to determine whether duloxetine is an effective treatment of attention deficit disorder in adults.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
  • Study Primary Completion Date: December 2010

Interventions Used in this Clinical Trial

  • Drug: duloxetine
    • 60 mg capsule once per day for 6 weeks
  • Drug: placebo
    • one capsule of placebo taken one a day for 6 weeks

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: duloxetine
  • Placebo Comparator: placebo

Outcome Measures for this Clinical Trial

Primary Measures

  • Impact of duloxetine on the Conners’ Adult attention-Deficit/Hyperactivity Disorder Rating Scale-Observer Report:Screening Version (CAARS-O:SV) in adult ADHD subjects.
    • Time Frame: baseline and week 6
      Safety Issue?: No

Secondary Measures

  • Impact of duloxetine on the Clinical Global Impression Scale in ADHD adults
    • Time Frame: baseline and week 6
      Safety Issue?: No
  • Impact of duloxetine on the Conners’ Adult attention-Deficit/Hyperactivity Disorder Rating Scale-Self Report : Long Version(44) (CAARS-S:L), in adult ADHD subjects.
    • Time Frame: baseline and week 6
      Safety Issue?: No
  • Impact of duloxetine on anxious and depressive symptoms in adult ADHD subjects.
    • Time Frame: baseline and week 6
      Safety Issue?: No
  • Impact of duloxetine on Quality of life in adults with ADHD
    • Time Frame: baseline and week 6
      Safety Issue?: No
  • Impact of duloxetine on executive functions and cognitive performances in adults with ADHD
    • Time Frame: baseline and week 6
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria

  • Clinical diagnosis of ADHD of at least moderate intensity
  • Able to give consent
  • Able to swallow capsules

Exclusion Criteria

  • Allergic or do not tolerate duloxetine
  • Under psychotherapy for ADHD
  • Taking a medication that interacts with duloxetine, including all psychotropic medication
  • Treated with medication for ADHD
  • Unstable medical condition
  • Severe renal insufficiency
  • Liver insufficiency
  • Substance/alcool abuse or dependency in the last 6 months
  • Pregnancy, nursing or inadequate contraceptive methods
  • Suicide or homicide risk
  • Organic brain syndrome
  • Any diagnosis of lifetime bipolar disorder or psychotic disorder, and any actual diagnosis of anxious disorder or major depressive disorder

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 50 Years

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Université de Montréal
  • Collaborator
    • Centre hospitalier de l’Université de Montréal (CHUM)
  • Provider of Information About this Clinical Study
    • Smadar Valérie Tourjman, Centre Hospitalier Universitaire de Montréal
  • Overall Official(s)
    • Valérie Tourjman, MD, Principal Investigator, Centre Hospitalier Universitaire de Montréal

References

Tourjman SV, Bilodeau M. Improvement with duloxetine in an adult ADHD patient. J Atten Disord. 2009 Jul;13(1):95-6. Epub 2009 Apr 9.

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00940693