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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00940693

Enrollment

Registered

2009-07-16

Start date

2009-08-31

Completion date

2010-12-31

Last updated

2010-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

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

Brief summary

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

Interventions

DRUGduloxetine

60 mg capsule once per day for 6 weeks

DRUGplacebo

one capsule of placebo taken one a day for 6 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

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

Design outcomes

Primary

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.	baseline and week 6

Secondary

Measure	Time frame
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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026