Phase 3
Completed N=2,017
A Long Term Study of a Medication for Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
Source: ClinicalTrials.gov NCT00700427 ↗Enrolled (actual)
2,017
Serious AEs
2.0%
Results posted
May 2013
Primary outcomePrimary: Percentage of Participants Who Maintain a Satisfactory Response During the Double-Blind Maintenance/Randomized Withdrawal Period — 64.3; 50.0 percentage of responders — p=0.001
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Maintain a Satisfactory Response During the Double-Blind Maintenance/Randomized Withdrawal Period |
64.3; 50.0 | 0.001 sig |
| SECONDARY Number of Days Until Relapse |
NA; NA | — |
| SECONDARY Change From Baseline in the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life (AAQoL) Scale From Week 24 to Week 49 |
0.4; -4.0 | 0.002 sig |
| SECONDARY Change From Baseline in Conner's Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (Observer Rated [CAARS-O:SV]) Total ADHD Symptom Score From Week 24 to Week 49 |
-2.60; -0.10; -1.90; -0.10; -1.60; -0.10 | <0.001 sig |
| SECONDARY Change From Baseline in Conner's Adult ADHD Rating Scale-Self Rated (CARRS-S:SV) Total ADHD Symptom Score From Week 24 to Week 49 |
-1.20; 0.90; -0.90; 0.50; -0.70; 1.20 | <0.001 sig |
| SECONDARY Change From Baseline in the Behavior Rating Inventory of Executive Function-Adult Version: Self Report (BRIEF-A:Self Report) Global Executive Composite (GEC) Index Score From Week 24 to Week 49 |
-5.70; 0.90 | 0.006 sig |
| SECONDARY Change From Baseline in the Behavior Rating Inventory of Executive Function-Adult Version:Informant Report (BRIEF-A:Informant) Global Executive Composite (GEC) Index Score From Week 24 to Week 49 |
-8.4; -0.6 | 0.006 sig |
| SECONDARY Change From Baseline in European Quality of Life (EuroQoL) Questionnaire-5 Dimensions (EQ-5D) Index Score From Week 24 to Week 49 |
0.00; 0.00; 0.00; 0.00; 4.60; 3.20 | — |
Eligibility Criteria
Inclusion Criteria
- Adults
- Male or female
- Must meet Attention-Deficit/Hyperactivity Disorder (ADHD) according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision™ (DSM-IV-TR™) criteria
Exclusion Criteria
- Comorbidity with major psychiatric disorder
- Clinically significant depression or anxiety
- Patients with significant medical conditions
- Current alcohol/drugs abuse/dependence
- Concomitant excluded medications
Data sourced from ClinicalTrials.gov (NCT00700427). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.