A Long Term Study of a Medication for Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
Summary
LYDO is a multi-center study that will enroll approximately 1925 adult outpatients with Attention Deficit/Hyperactivity Disorder (ADHD). Patients will receive, under open label conditions, atomoxetine up to 100 mg/day during the acute, open-label part of the study. Those patients that meet the response criteria will continue the blind phase of the study up to a year. During that period, patients that respond to atomoxetine will be randomized to continue the treatment with atomoxetine or with placebo (neither the patients nor investigators know if patients receive atomoxetine or placebo).
Timeline
- Start
- 2008-06
- Primary completion
- 2011-08
- Completion
- 2013-10
Outcome
Met primary endpoint
registry NUMBER Atomoxetine: 64.3 percentage of responders NCT00700427 ↗
registry analysis (superiority or other test); Atomoxetine vs Placebo; p = 0.001; Fisher Exact NCT00700427 ↗
Publications
- Tanaka Y, Escobar R, Upadhyaya HP. Assessment of effects of atomoxetine in adult patients with ADHD: consistency among three geographic regions in a response maintenance study. Atten Defic Hyperact Disord. 2017 Jun;9(2):113-120. doi: 10.1007/s12402-016-0212-7. Epub 2017 Jan 6.
- Upadhyaya H, Tanaka Y, Lipsius S, Kryzhanovskaya LA, Lane JR, Escobar R, Trzepacz PT, Allen AJ. Time-to-onset and -resolution of adverse events before/after atomoxetine discontinuation in adult patients with ADHD. Postgrad Med. 2015;127(7):677-85. doi: 10.1080/00325481.2015.1083394. Epub 2015 Sep 2.
- Upadhyaya H, Adler LA, Casas M, Kutzelnigg A, Williams D, Tanaka Y, Arsenault J, Escobar R, Allen AJ. Baseline characteristics of European and non-European adult patients with attention deficit hyperactivity disorder participating in a placebo-controlled, randomized treatment study with atomoxetine. Child Adolesc Psychiatry Ment Health. 2013 May 6;7(1):14. doi: 10.1186/1753-2000-7-14.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atomoxetine | Other / unclassified | 40 mg | Oral |
| Subject | Atomoxetine | Other / unclassified | 80 mg | Oral |
| Subject | Atomoxetine | Other / unclassified | 100 mg | Oral |