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

Université de Montréal

Status and phase: Completed; Phase 2

Conditions: Attention Deficit Disorder With Hyperactivity

Treatments: Drug: duloxetine; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00940693

09.008

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

duloxetine

Active Comparator group

Treatment:

Drug: duloxetine

placebo

Placebo Comparator group

Treatment:

Drug: placebo