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

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

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

Conditions
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Attention Deficit Disorder With Hyperactivity

Intervention / Treatment
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* Drug: duloxetine
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: duloxetine<br> | Drug: duloxetine<br>* 60 mg capsule once per day for 6 weeks<br>* Other names: cymbalta;|
| Placebo Comparator: placebo<br> | Drug: placebo<br>* one capsule of placebo taken one a day for 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Attention Deficit Disorder with Hyperactivity, Duloxetine, Adult, ADDH, ADHD