Skip to main content
OpenTrials
Completed

NCT Number: NCT00940693

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Attention Deficit Disorder With Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre Hospitalier Universitaire de Montréal: Hôpital Notre-Dame

Montreal, Quebec, H2L 4M1, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Duloxetine

Drug

60 mg capsule once per day for 6 weeks

Other names: cymbalta

Placebo

Drug

one capsule of placebo taken one a day for 6 weeks

Primary outcomes

  1. 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

Secondary outcomes

  1. Impact of duloxetine on the Clinical Global Impression Scale in ADHD adults

    Time frame: baseline and week 6

  2. 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

  3. Impact of duloxetine on anxious and depressive symptoms in adult ADHD subjects.

    Time frame: baseline and week 6

  4. Impact of duloxetine on Quality of life in adults with ADHD

    Time frame: baseline and week 6

  5. Impact of duloxetine on executive functions and cognitive performances in adults with ADHD

    Time frame: baseline and week 6

Sponsors and collaborators

Lead sponsor

Université de Montréal

Other

Collaborators

  • Centre hospitalier de l'Université de Montréal (CHUM)

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 16, 2009
Registry last updated
Dec 14, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.