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

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ClinicalTrials.gov Identifier: NCT00940693
Recruitment Status : Completed
First Posted : July 16, 2009
Last Update Posted : December 14, 2010
Sponsor:
Collaborator:
Information provided by:

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

Condition or disease Intervention/treatment Phase
Attention Deficit Disorder With Hyperactivity Drug: duloxetine Drug: placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Study of the Efficacy of Duloxetine in Treating Adults With Attention Deficit Hyperactivity Disorder: a Randomized, Controlled Trial.
Study Start Date : August 2009
Primary Completion Date : December 2010
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: duloxetine Drug: duloxetine
60 mg capsule once per day for 6 weeks
Other Name: cymbalta
Placebo Comparator: placebo Drug: placebo
one capsule of placebo taken one a day for 6 weeks


Outcome Measures

Primary Outcome Measures :
  1. 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 Measures :
  1. Impact of duloxetine on the Clinical Global Impression Scale in ADHD adults [ Time Frame: baseline and week 6 ]
  2. 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 ]
  3. Impact of duloxetine on anxious and depressive symptoms in adult ADHD subjects. [ Time Frame: baseline and week 6 ]
  4. Impact of duloxetine on Quality of life in adults with ADHD [ Time Frame: baseline and week 6 ]
  5. Impact of duloxetine on executive functions and cognitive performances in adults with ADHD [ Time Frame: baseline and week 6 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00940693


Locations
Canada, Quebec
Centre Hospitalier Universitaire de Montréal: Hôpital Notre-Dame
Montreal, Quebec, Canada, H2L 4M1
Sponsors and Collaborators
Université de Montréal
Centre hospitalier de l'Université de Montréal (CHUM)
Investigators
Principal Investigator: Valérie Tourjman, MD Centre Hospitalier Universitaire de Montréal
More Information

Publications:
Responsible Party: Smadar Valérie Tourjman, Centre Hospitalier Universitaire de Montréal
ClinicalTrials.gov Identifier: NCT00940693     History of Changes
Other Study ID Numbers: 09.008
First Posted: July 16, 2009    Key Record Dates
Last Update Posted: December 14, 2010
Last Verified: December 2010

Keywords provided by Université de Montréal:
Attention Deficit Disorder with Hyperactivity
Duloxetine
Adult
ADDH
ADHD

Additional relevant MeSH terms:
Disease
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Nervous System Diseases
Hyperkinesis
Pathologic Processes
Dyskinesias
Neurologic Manifestations
Signs and Symptoms
Duloxetine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents