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

December 13, 2010 updated by: Université de Montréal

Pilot Study of the Efficacy of Duloxetine in Treating Adults With Attention Deficit Hyperactivity Disorder: a Randomized, Controlled Trial.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2L 4M1
        • Centre Hospitalier Universitaire de Montréal: Hôpital Notre-Dame

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Drug: placebo
one capsule of placebo taken one a day for 6 weeks
Active Comparator: duloxetine
Drug: duloxetine
60 mg capsule once per day for 6 weeks
Other Names:
  • cymbalta

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
baseline and week 6

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université de Montréal

Collaborators

Centre hospitalier de l'Université de Montréal (CHUM)

Investigators

  • Principal Investigator: Valérie Tourjman, MD, Centre Hospitalier de l'Université de Montréal (CHUM)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

July 15, 2009

First Submitted That Met QC Criteria

July 15, 2009

First Posted (Estimate)

July 16, 2009

Study Record Updates

Last Update Posted (Estimate)

December 14, 2010

Last Update Submitted That Met QC Criteria

December 13, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09.008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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