Pilot Study of Duloxetine in Adult Attention Deficit Hyperactivity Disorder(ADHD)
Information source: Université de Montréal
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Attention Deficit Disorder With Hyperactivity
Intervention: duloxetine (Drug); placebo (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Université de Montréal Official(s) and/or principal investigator(s): Valérie Tourjman, MD, Principal Investigator, Affiliation: Centre Hospitalier Universitaire de Montréal
Summary
The purpose of this study is to determine whether duloxetine is an effective treatment of
attention deficit disorder in adults.
Clinical Details
Official title: Pilot Study of the Efficacy of Duloxetine in Treating Adults With Attention Deficit Hyperactivity Disorder: a Randomized, Controlled Trial.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Impact of duloxetine on the Conners' Adult attention-Deficit/Hyperactivity Disorder Rating Scale-Observer Report:Screening Version (CAARS-O:SV) in adult ADHD subjects.
Secondary outcome: Impact of duloxetine on the Clinical Global Impression Scale in ADHD adultsImpact of duloxetine on the Conners' Adult attention-Deficit/Hyperactivity Disorder Rating Scale-Self Report : Long Version(44) (CAARS-S:L), in adult ADHD subjects. Impact of duloxetine on anxious and depressive symptoms in adult ADHD subjects. Impact of duloxetine on Quality of life in adults with ADHD Impact of duloxetine on executive functions and cognitive performances in adults with ADHD
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Centre Hospitalier Universitaire de Montréal: Hôpital Notre-Dame, Montreal, Quebec H2L 4M1, Canada
Additional Information
Related publications: Tourjman SV, Bilodeau M. Improvement with duloxetine in an adult ADHD patient. J Atten Disord. 2009 Jul;13(1):95-6. doi: 10.1177/1087054708326109. Epub 2009 Apr 9.
Starting date: August 2009
Last updated: December 13, 2010
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