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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 adults

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.

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

Page last updated: August 20, 2015

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