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

This study has been completed.
Sponsor:
Collaborator:
Centre hospitalier de l'Université de Montréal (CHUM)
Information provided by:
Université de Montréal
ClinicalTrials.gov Identifier:
NCT00940693
First received: July 15, 2009
Last updated: December 13, 2010
Last verified: December 2010
  Purpose

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


Condition Intervention Phase
Attention Deficit Disorder With Hyperactivity
Drug: duloxetine
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by Université de Montréal:

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. [ Time Frame: baseline and week 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Impact of duloxetine on the Clinical Global Impression Scale in ADHD adults [ Time Frame: baseline and week 6 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Impact of duloxetine on anxious and depressive symptoms in adult ADHD subjects. [ Time Frame: baseline and week 6 ] [ Designated as safety issue: No ]
  • Impact of duloxetine on Quality of life in adults with ADHD [ Time Frame: baseline and week 6 ] [ Designated as safety issue: No ]
  • Impact of duloxetine on executive functions and cognitive performances in adults with ADHD [ Time Frame: baseline and week 6 ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: August 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: July 15, 2009
Last Updated: December 13, 2010
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Nervous System Diseases
Hyperkinesis
Dyskinesias
Neurologic Manifestations
Signs and Symptoms
Duloxetine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Adrenergic Uptake Inhibitors
Adrenergic Agents
Dopamine Uptake Inhibitors
Dopamine Agents

ClinicalTrials.gov processed this record on August 25, 2014