A Long Term Study of a Medication for Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00700427
First received: June 16, 2008
Last updated: June 12, 2014
Last verified: June 2014

June 16, 2008
June 12, 2014
June 2008
August 2011   (final data collection date for primary outcome measure)
Percentage of Participants Who Maintain a Satisfactory Response During the Double-Blind Maintenance/Randomized Withdrawal Period [ Time Frame: Baseline (Week 24) up to Week 49 ] [ Designated as safety issue: No ]
Conners' Adult ADHD Rating Scale-Investigator Rated:Screening Version (CAARS-Inv:SV); 30-item scale (3 subscales): inattention, hyperactivity/impulsivity (9 items each), ADHD Index (12 items). Each item is scored 0 (not at all/never) to 3 (very much/very frequently). Total ADHD symptoms score (SS)=inattention+hyperactivity/impulsivity (range:0-54). Higher score=more impairment. Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S) measures participant's overall severity of ADHD symptoms and scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Maintenance of response during the randomized withdrawal phase was a reduction of ≥30% in the baseline CAARS-Inv:SV Total ADHD SS and a CGI-ADHD-S score ≤3. Participants had to continuously meet the response criteria, except for 1 excursion after assessment at Week 24 through Week 37 and 1 other excursion after assessment at Week 37 through Week 49. Excursions were not permitted at 2 consecutive visits.
Proportion of patients who maintain a satisfactory response [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00700427 on ClinicalTrials.gov Archive Site
  • Number of Days Until Relapse [ Time Frame: Baseline (Week 24) up to Week 49 ] [ Designated as safety issue: No ]

    Relapse was defined as 2 consecutive visits with a CGI-ADHD-S score ≥4 points and a return to ≥80% of participant's baseline (Visit 2) CAARS-Inv:SV Total ADHD Symptom Score (SS). If the participant showed evidence of a return of symptoms at a single visit that met severity criteria described above, and because of worsening symptoms, was unwilling to remain in the study or did not return for a second visit, the participant was also considered to have relapsed.

    CAARS-Inv:SV is a 30-item scale (3 subscales): Inattention, Hyperactivity/Impulsivity (9 items each), ADHD Index (12 items). Each item is scored 0 (0=not at all/never) to 3 (very much/very frequently). Total ADHD SS=inattention+hyperactivity/impulsivity (range: 0-54). Higher score=more impairment. CGI-ADHD-S measures participant's overall severity of ADHD symptoms and scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).

  • Change From Baseline in the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life (AAQoL) Scale From Week 24 to Week 49 [ Time Frame: Baseline (Week 24), Week 49 ] [ Designated as safety issue: No ]
    The AAQoL is a self-reported, 29-item scale assessing functional impairments in adults with ADHD. Each item is rated on a 5-point Likert scale; range: 1 (Not at all/ Never) to 5 (Extremely/Very Often). 5-domains of scale include: work functioning, family relationships, social functioning, activities of daily living (driving, managing finances), and psychological adaptation (life satisfaction, self-esteem). These scores are transformed to a 0-100 point scale (1=0; 2=25; 3=50; 4=75; 5=100), and then the item scores are summed and divided by item count to generate overall scores. The overall scores have the same total range of scores of 0-100, with higher scores indicating better quality of life. Least Squares (LS) Mean values were adjusted for baseline AAQoL score and Investigator/site.
  • 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 [ Time Frame: Baseline (Week 24), Week 49 ] [ Designated as safety issue: No ]
    The CAARS-O:SV is a 30-item observer (typically a significant other or close friend) completed scale containing 3 subscales: inattention (9 items), hyperactivity/impulsivity (9 items), and ADHD Index (12 items). Each item is scored 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Inattention and hyperactivity subscales range from 0-27; ADHD index subscale range is 0-36 with higher scores indicating more impaired participants. Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales, ranging from 0-54, with higher scores indicating more impaired participants. Least Squares (LS) Mean values adjusted for treatment, pooled Investigator, and baseline.
  • 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 [ Time Frame: Baseline (Week 24), Week 49 ] [ Designated as safety issue: No ]
    CAARS-S:SV is a 30-item participant completed scale containing 3 subscales: inattention (9 items), hyperactivity/impulsivity (9 items), ADHD Index (12 items). 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Inattention and hyperactivity subscales range from 0-27; ADHD index subscale range is 0-36 with higher scores indicating more impaired participants. Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales; range: 0-54 with higher scores indicating more impaired participants. Least Squares (LS) Mean values adjusted for treatment, pooled Investigator, and baseline.
  • 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 [ Time Frame: Baseline (Week 24), Week 49 ] [ Designated as safety issue: No ]
    The BRIEF-A:Self Report is a 75-item self-reported measure captures adults' views of their own executive functions/self-regulation in their everyday environment. Items include: Inhibit, Shift, Emotional Control, Self Monitor, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organization of Materials. Behavior is rated on a 3-point scale: 1 (behavior is never observed) to 3 (behavior is often observed). GEC Index Score is a subscore of the 75-item BRIEF-A score, reflects overall functioning and was calculated based on 70 items. Total scores range: 70-210. Lower scores = less perceived impairment. Least Squares (LS) Mean values were adjusted for treatment, pooled Investigator, and baseline.
  • 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 [ Time Frame: Baseline (Week 24), Week 49 ] [ Designated as safety issue: No ]
    BRIEF-A:Informant is a 75-item third-party observer's view of the participants' executive functions/self-regulation in their everyday environment. Items include: Inhibit, Shift, Emotional Control, Self Monitor, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organization of Materials. Behavior is rated on a 3-point scale: 1 (behavior is never observed) to 3 (behavior is often observed). GEC Index Score is a subscore of the 75-item BRIEF-A score, reflects overall functioning and was calculated based on 70 items. Total scores range: 70-210. Lower scores = less perceived impairment. Least Squares (LS) Mean values were adjusted for treatment, pooled Investigator, and baseline.
  • Change From Baseline in European Quality of Life (EuroQoL) Questionnaire-5 Dimensions (EQ-5D) Index Score From Week 24 to Week 49 [ Time Frame: Baseline (Week 24), Week 49 ] [ Designated as safety issue: No ]
    The EQ-5D is a Self-reported, 5-item scale to assess health utility (mobility, self-care, usual activities, pain and discomfort, and depression/anxiety). Scoring is on a 3-point scale (1=no health problems, 2=some or moderate problems, 3=major health problems). A preference value Index score is calculated using societal preference developed from a general population-based valuation studies. Index score ranges: United Kingdom (UK): -0.59 to 1.0, United States (US): -0.11 to 1.0, where 1 represents best possible health and 0 represents dead, with <0 interpreted as a health state "worse than dead." A Quality of Life Health State Score visual analog scale (VAS) was assessed, scores range from 0 to 100. Higher scores indicate better health state. Least Square (LS) Mean values were adjusted for treatment, pooled Investigator, baseline.
  • Number of days until relapse [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • The change of Adult ADHD Quality of Life scores from baseline to end point [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Long Term Study of a Medication for Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
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

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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Attention Deficit Hyperactivity Disorder
  • Drug: atomoxetine hydrochloride
    Oral 40-100 mg/day
    Other Names:
    • Strattera
    • LY139603
    • atomoxetine
  • Drug: Placebo
    Oral delivery of matching placebo
  • Experimental: Atomoxetine
    Atomoxetine 40-100 milligrams per day (mg/day) orally, once daily or twice daily for 24 weeks, followed by atomoxetine 80-100 mg/day orally, once daily or twice daily for 25 weeks.
    Intervention: Drug: atomoxetine hydrochloride
  • Placebo Comparator: Placebo
    Atomoxetine 40-100 mg/day orally, once daily or twice daily for 24 weeks, followed by placebo orally, once daily for 25 weeks.
    Interventions:
    • Drug: atomoxetine hydrochloride
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2017
October 2013
August 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Belgium,   Finland,   France,   United Kingdom,   Italy,   Netherlands,   Portugal,   Spain,   Sweden,   Switzerland,   Austria
 
NCT00700427
9655, B4Z-MC-LYDO
No
Eli Lilly and Company
Eli Lilly and Company
Not Provided
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5hours, EST) Eli Lilly and Company
Eli Lilly and Company
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP