A Randomized, Double-Blind Comparison of Placebo and Atomoxetine Hydrochloride Given Once a Day in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)

Lilly

Status and phase: Completed; Phase 4

Conditions: Attention Deficit Hyperactivity Disorder

Treatments: Drug: Placebo; Drug: Atomoxetine Hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00190775

B4Z-US-LYCW (Other Identifier)

9043

Details and patient eligibility

About

This is a parallel design, double-blind, placebo-controlled, multi-center, 38-week treatment trial of atomoxetine in adults with attention deficit hyperactivity disorder (ADHD) who are currently living in a family situation with at least one child. The primary objective of the study is to demonstrate the efficacy of atomoxetine compared to placebo in the reduction of ADHD symptoms over 12 and 24 weeks of blinded treatment.

Full description

The initial study was 34 weeks long; however, the protocol was amended to extend the open-label period of the study from 8 weeks to 12 weeks (38 weeks total).

Enrollment: 502 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Meet Diagnostic and Statistical Manual of Mental Disorders Fourth Edition - Text Revision (DSM-IV-TR) criteria for Adult Attention-Deficit/Hyperactivity Disorder (ADHD) as assessed by the Conners' Adult ADHD Diagnostic Interview for DSM-IV (CAADID).
• Have a Clinical Global Impression for ADHD Severity Score (CGI-ADHD-S) of 4 or greater Visit 2 and 3.
• Adult Men and Women age 18 years or older at time informed consent is obtained.
• Must be in a reciprocal relationship with a person of the opposite sex living in same defined household (cohabitating) with their spouse/significant other for a period of at least 3 months. This spouse/significant other cannot change during the study.
• Must have one or more children 6-17 years of age living the home as the primary residence.

Exclusion criteria

• Anyone meeting Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for any history of bipolar disorder or any history of a psychotic disorder.
• Anyone meeting diagnostic (DSM-IV) criteria for current major depression or current anxiety disorder.
• Taking psychotropic medications on a regular basis.
• Having any medical condition that would be exacerbated or not appropriate for inclusion in this trial.
• Previously taken an adequate trial of atomoxetine.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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502 participants in 2 patient groups, including a placebo group

Atomoxetine

Experimental group

Description:

Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 60/80/100 mg as determined by the investigator up to 24 weeks, orally

Treatment:

Drug: Atomoxetine Hydrochloride

Placebo

Placebo Comparator group

Description:

Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally.

Treatment:

Drug: Placebo