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

Primary Purpose

Attention Deficit Disorder With Hyperactivity

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
duloxetine
placebo
Sponsored by
Université de Montréal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Disorder With Hyperactivity focused on measuring Attention Deficit Disorder with Hyperactivity, Duloxetine, Adult, ADDH, ADHD

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier Universitaire de Montréal: Hôpital Notre-Dame

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

duloxetine

placebo

Arm Description

Outcomes

Primary Outcome Measures

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 Measures

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

Full Information

First Posted
July 15, 2009
Last Updated
December 13, 2010
Sponsor
Université de Montréal
Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
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1. Study Identification

Unique Protocol Identification Number
NCT00940693
Brief Title
Pilot Study of Duloxetine in Adult Attention Deficit Hyperactivity Disorder(ADHD)
Official Title
Pilot Study of the Efficacy of Duloxetine in Treating Adults With Attention Deficit Hyperactivity Disorder: a Randomized, Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Université de Montréal
Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder With Hyperactivity
Keywords
Attention Deficit Disorder with Hyperactivity, Duloxetine, Adult, ADDH, ADHD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
duloxetine
Arm Type
Active Comparator
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
duloxetine
Other Intervention Name(s)
cymbalta
Intervention Description
60 mg capsule once per day for 6 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
one capsule of placebo taken one a day for 6 weeks
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Impact of duloxetine on the Clinical Global Impression Scale in ADHD adults
Time Frame
baseline and week 6
Title
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
Title
Impact of duloxetine on anxious and depressive symptoms in adult ADHD subjects.
Time Frame
baseline and week 6
Title
Impact of duloxetine on Quality of life in adults with ADHD
Time Frame
baseline and week 6
Title
Impact of duloxetine on executive functions and cognitive performances in adults with ADHD
Time Frame
baseline and week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valérie Tourjman, MD
Organizational Affiliation
Centre hospitalier de l'Université de Montréal (CHUM)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Montréal: Hôpital Notre-Dame
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
19359667
Citation
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.
Results Reference
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Pilot Study of Duloxetine in Adult Attention Deficit Hyperactivity Disorder(ADHD)

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