Clinical Study Data Request
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Proposal 1566

Title of the Proposed Research

A microanalysis of symptoms and behaviors defining ADHD in adults and their response to both active medication and placeb

Lead Researcher

Frederick W. Reimherr MD


University of Utah School of Medicine Department of Psychiatry & Psychiatric & Behavioral Solutions LLC

Funding Source

This reanalysis is self-funded. No government or industry grants will be used.

Potential Conflicts of Interest


Data Sharing Agreement Date

4 October 2016

Lay Summary

The American Psychiatric Association’s Diagnostic and Statistical Manual (DSM) in its various editions has defined psychiatric illnesses since the 1950’s. The term Attention Deficit Disorder was introduced within DSM-III. In 1994, it was renamed Attention Deficit Hyperactivity Disorder (ADHD). Most DSM adult DSM diagnoses are defined by symptom domains. In medicine “symptoms” are complaints patients bring to the doctor; and “symptoms domains” are groups of related symptoms. In medicine “signs” are what the doctor observes or discovers, not a patient’s report. While other DSM diagnosis use symptom clusters, ADHD criteria use relatively narrow behavioral signs. Although apt in defining ADHD in children, these criteria work less well in adults. The DSM uses a summation of 18 behaviors - attention, hyperactive, and impulsive signs - to make an ADHD diagnosis. A shortcoming of this approach is that there is little information as to the relative importance of each item or its relative treatment response. More adults are now being diagnosed with ADHD. However, diagnosis is still based on childhood signs not adult symptom domains.

Our research group and others have pointed to the critical role of emotional symptoms in ADHD. Conversely, these ADHD emotional symptoms (temper, lability, over-reactivity, and tension) are not part of the DSM diagnostic system. Further, the hyperactivity observed in children is hard to detect in adults while impulsive criteria (blurting things out and intruding on others) poorly reflect the impulse problems in adults.

ADHD affects 3-5% of children & often continues into adulthood. It creates significant disability, including poor work & social function, drug abuse, & legal problems. While diagnostic criteria for ADHD include documented childhood onset, recent reports suggest that adults with ADHD may have a later onset form. Defining the diagnosis using symptoms more appropriate for adults may lead to higher rates.

This analysis will focus on specific symptoms of ADHD using the broadest spectrum of ADHD instruments available. It will include assessing peripheral measures like anxiety, depression and social function. Use of a spectrum of symptoms across differing subject pools should identify symptoms which are diagnostically useful, statistically reliable and medically important. Specifically:

Which ADHD symptoms are most frequent in adults with ADHD?

Which symptoms associate most with impairment?

Which symptoms respond to medication treatment, as opposed to change over time or placebo?

Results will be presented at professional meetings and publications.

Study Data Provided

LILLY-B4Z-MC-LYAA: A Phase III Randomized, Double-Blind Comparison of Placebo and Tomoxetine Hydrochloride in Adult Outpatients with DSM-IV Attention-Deficit/Hyperactivity Disorder.
LILLY-B4Z-MC-LYAO: A Phase III Randomized, Double-Blind Comparison of Placebo and Tomoxetine Hydrochloride in Adult Outpatients with DSM-IV Attention- Deficit/Hyperactivity Disorder
LILLY-B4Z-MC-LYDO: Maintenance of Response After Open-Label Treatment With Atomoxetine Hydrochloride in Adult Outpatients With Attention-Deficit/Hyperactivity Disorder (ADHD): A Placebo-Controlled, Randomized Withdrawal Study
LILLY-B4Z-US-LYCW: A Randomized, Double-Blind Comparison of Placebo and Atomoxetine Hydrochloride Given Once a Day in Adults with Attention-Deficit/Hyperactivity Disorder: with a Secondary Examination of Impact of Treatment on Family Functioning
LILLY-B4Z-JE-LYEE: A Double-Blind Placebo-Controlled Asian Study of Atomoxetine Hydrochloride in the Treatment of Adult Patients with Attention-Deficit/Hyperactivity Disorder (ADHD)
LILLY-B4Z-US-LYCU: Efficacy and Safety of Once-Daily Atomoxetine Hydrochloride in Adults with ADHD Over an Extended Period of Time (6 months): with A Brief Evaluation of Executive Cognition
LILLY-B4Z-US-LYDQ: Phase IV Placebo-Controlled Study of Atomoxetine Hydrochloride in the Treatment of Adults With ADHD and Comorbid Social Anxiety Disorder
LILLY-B4Z-MC-LYBV: A Double-Blind Study of Functional Outcomes With Atomoxetine-Hydrochloride and Placebo in Adult Outpatients With DSM-IV Attention-Deficit/Hyperactivity Disorder

Statistical Analysis Plan

The statistical analysis plan will be added after the research is published.

Publication Citation

The publication citation will be added after the research is published.

Summary Results

Results summary or link will be posted when available.