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

NCT00940693 | Completed Phase 2

• 1 other identifier: 09.008
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

Attention Deficit Disorder with Hyperactivity; Duloxetine; Adult; ADDH; ADHD

Outcome Measures

Primary Outcomes (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.

  baseline and week 6

Secondary Outcomes (5)

• 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

Study Arms (2)

duloxetine

ACTIVE COMPARATOR

Drug: duloxetine

placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

duloxetine DRUG

60 mg capsule once per day for 6 weeks

Also known as: cymbalta

duloxetine

placebo DRUG

one capsule of placebo taken one a day for 6 weeks

placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Clinical diagnosis of ADHD of at least moderate intensity
• Able to give consent
• Able to swallow capsules

You may not qualify if:

• 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

Sponsors & Collaborators

• Université de Montréal: lead
• Centre hospitalier de l'Université de Montréal (CHUM): collaborator

Study Sites (1)

Centre Hospitalier Universitaire de Montréal: Hôpital Notre-Dame

Montreal, Quebec, H2L 4M1, Canada

Location

Related Publications (1)

• 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.

  PMID: 19359667 BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Valérie Tourjman, MD

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 15, 2009
• First Posted: July 16, 2009
• Study Start: August 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: December 14, 2010

Record last verified: 2010-12

Locations

CA (1)