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

Phase 2

Completed

• Conditions: Attention Deficit Disorder With Hyperactivity
• Interventions: Drug: placebo; Drug: duloxetine

• Registration Number: NCT00940693
• Lead Sponsor: Université de Montréal

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-07-15
• Study First Submitted QC: 2009-07-15
• Study First Posted: 2009-07-16
• Study Start: 2009-08
• Status Verified: 2010-12
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Last Update Submitted: 2010-12-13
• Last Update Posted: 2010-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	-
duloxetine	duloxetine	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Impact of duloxetine on the Clinical Global Impression Scale in ADHD adults	baseline and week 6
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
Impact of duloxetine on anxious and depressive symptoms in adult ADHD subjects.	baseline and week 6
Impact of duloxetine on Quality of life in adults with ADHD	baseline and week 6
Impact of duloxetine on executive functions and cognitive performances in adults with ADHD	baseline and week 6

Trial Locations

Locations (1)

Centre Hospitalier Universitaire de Montréal: Hôpital Notre-Dame; 🇨🇦 Montreal, Quebec, Canada