NCT00700427

Brief 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).

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,017

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2008

Longer than P75 for phase_3

Geographic Reach
12 countries

56 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 18, 2008

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

May 29, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

June 26, 2014

Status Verified

June 1, 2014

Enrollment Period

3.2 years

First QC Date

June 16, 2008

Results QC Date

August 23, 2012

Last Update Submit

June 12, 2014

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHDAdultlong termmaintenance of responseAttention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Who Maintain a Satisfactory Response During the Double-Blind Maintenance/Randomized Withdrawal Period

    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.

    Baseline (Week 24) up to Week 49

Secondary Outcomes (7)

  • Number of Days Until Relapse

    Baseline (Week 24) up to Week 49

  • Change From Baseline in the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life (AAQoL) Scale From Week 24 to Week 49

    Baseline (Week 24), Week 49

  • 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

    Baseline (Week 24), Week 49

  • 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

    Baseline (Week 24), Week 49

  • 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

    Baseline (Week 24), Week 49

  • +2 more secondary outcomes

Study Arms (2)

Atomoxetine

EXPERIMENTAL

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.

Drug: atomoxetine hydrochloride

Placebo

PLACEBO COMPARATOR

Atomoxetine 40-100 mg/day orally, once daily or twice daily for 24 weeks, followed by placebo orally, once daily for 25 weeks.

Drug: atomoxetine hydrochlorideDrug: Placebo

Interventions

atomoxetine hydrochlorideDRUG

Oral 40-100 mg/day

Also known as: Strattera, LY139603, atomoxetine
AtomoxetinePlacebo
PlaceboDRUG

Oral delivery of matching placebo

Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Comorbidity with major psychiatric disorder
  • Clinically significant depression or anxiety
  • Patients with significant medical conditions
  • Current alcohol/drugs abuse/dependence
  • Concomitant excluded medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (56)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Vienna, A1090, Austria

Location

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Bruges, 8310, Belgium

Location

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Kortenberg, 3070, Belgium

Location

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Liège, 4000, Belgium

Location

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Mechelen, 2800, Belgium

Location

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Uccle, 1180, Belgium

Location

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Helsinki, 00029 HUS, Finland

Location

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Tampere, 33100, Finland

Location

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Turku, 20100, Finland

Location

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Bordeaux, 33076, France

Location

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Douai, 59500, France

Location

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Marseille, 13009, France

Location

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Montpellier, 34295, France

Location

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Nice, 06200, France

Location

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Orvault, 44000, France

Location

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Ahrensburg, 22926, Germany

Location

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Berlin, D-14050, Germany

Location

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Bochum, 44791, Germany

Location

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Ellwangen, 73479, Germany

Location

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Essen, D-45147, Germany

Location

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Freiburg im Breisgau, 79104, Germany

Location

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Fulda, 36037, Germany

Location

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Hadamar, 65589, Germany

Location

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Hagen, 58093, Germany

Location

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Hamburg, 22527, Germany

Location

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Hanover, 30625, Germany

Location

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Homburg, 66421, Germany

Location

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Leipzig, 04157, Germany

Location

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Ludwigshafen, 67071, Germany

Location

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Mainz, 55131, Germany

Location

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Mannheim, 68159, Germany

Location

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Munich, 80333, Germany

Location

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Würzburg, 97070, Germany

Location

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Coppito, 67100, Italy

Location

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Milan, 20121, Italy

Location

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San Donà di Piave, 30027, Italy

Location

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Amersfoort, 3816 CP, Netherlands

Location

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Flushing, 4382 EE, Netherlands

Location

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Hengelo, 7555 DL, Netherlands

Location

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Nijmegen, 6500 HB, Netherlands

Location

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Tilburg, 5037 SK, Netherlands

Location

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Cascais, 2750-782, Portugal

Location

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Coimbra, 3030, Portugal

Location

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Alcorcón, 28922, Spain

Location

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Barcelona, 08035, Spain

Location

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Madrid, 28002, Spain

Location

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Pamplona, 31008, Spain

Location

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Zamora, 49021, Spain

Location

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Luleå, SE 972 35, Sweden

Location

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Lund, 22361, Sweden

Location

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Malmo, 21135, Sweden

Location

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Vaxjo, SE 351 88, Sweden

Location

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Lausanne, 1005, Switzerland

Location

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Brighton, East Sussex, BN1 3RJ, United Kingdom

Location

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Storrington, West Sussex, RH20 4NQ, United Kingdom

Location

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London, SE5 8AZ, United Kingdom

Location

Related Publications (3)

  • 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.

    PMID: 28058589DERIVED

  • 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.

    PMID: 26329980DERIVED

  • 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.

    PMID: 23648011DERIVED

Related Links

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • 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

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2008

First Posted

June 18, 2008

Study Start

June 1, 2008

Primary Completion

August 1, 2011

Study Completion

October 1, 2013

Last Updated

June 26, 2014

Results First Posted

May 29, 2013

Record last verified: 2014-06

Locations

NL(5)DE(18)SE(4)FR(6)BE(5)ES(5)CH(1)PT(2)GB(3)AU(1)IT(3)FI(3)