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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00940693
Other study ID # 09.008
Secondary ID
Status Completed
Phase Phase 2
First received July 15, 2009
Last updated December 13, 2010
Start date August 2009
Est. completion date December 2010

Study information

Verified date December 2010
Source Université de Montréal
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 50 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms

  • Attention Deficit Disorder With Hyperactivity
  • Hyperkinesis

Intervention

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

Locations

Country Name City State
Canada Centre Hospitalier Universitaire de Montréal: Hôpital Notre-Dame Montreal Quebec

Sponsors (2)

Lead Sponsor Collaborator
Université de Montréal Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Impact of duloxetine on the Conners' Adult attention-Deficit/Hyperactivity Disorder Rating Scale-Observer Report:Screening Version (CAARS-O:SV) in adult ADHD subjects. baseline and week 6 No
Secondary Impact of duloxetine on the Clinical Global Impression Scale in ADHD adults baseline and week 6 No
Secondary 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. baseline and week 6 No
Secondary Impact of duloxetine on anxious and depressive symptoms in adult ADHD subjects. baseline and week 6 No
Secondary Impact of duloxetine on Quality of life in adults with ADHD baseline and week 6 No
Secondary Impact of duloxetine on executive functions and cognitive performances in adults with ADHD baseline and week 6 No
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