Attention Deficit Disorder With HyperactivityPhase 3NCT00320528

Efficacy of Atomoxetine on Psychosocial Function of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)

A Phase 3 study testing atomoxetine in people with Attention Deficit Disorder With Hyperactivity, run by Eli Lilly and Company at 20 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study aims to assess the effectiveness of atomoxetine on psychosocial functioning and emotional well being of children and adolescents with ADHD and to evaluate whether and in what measure the presence of comorbid conditions (internalizing and externalizing disorders) influences atomoxetine's ability to improve… Read more about this study

Who is it for?: Ages 6 to 15 years
Conditions the study is for: Attention Deficit Disorder With Hyperactivity
What is being tested?: atomoxetine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 269 participants
Where: 20 sitesItaly
Study dates: Apr 2006to Oct 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 15 years
All sexes
No healthy volunteers
Child

Who may be able to join

Child or adolescent patients, male or female outpatients, who are at least 6 years of age, but must not yet have reached their 16th birthday prior to Visit 1, when informed consent is obtained
Patients must meet Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) diagnostic criteria for ADHD (any subtype) and score at least 1.5 standard deviations above the age norm for their diagnostic subtype using published norms for the Swanson, Nolan and Pelham Questionnaire: Attention-Deficit/Hyperactivity Disorder Subscale (SNAP-IV ADHD Subscale) score at both Visit 1 and 2
Laboratory results, including serum chemistries, hematology, and urinalysis, must show no clinically significant abnormalities (clinically significant is defined as laboratory values requiring acute medical intervention, indicating a serious medical illness, or requiring further medical evaluation in the judgment of the investigator)
An electrocardiogram (ECG) must be performed to exclude cardiac diseases at the baseline/screening visit and the results must be reviewed by the investigator at Visit 2 prior to dispensing of study material
Patients and parents have been judged by the investigator to be reliable to keep appointments for clinic visits and all tests, including venipuncture, and examinations required by the protocol.

Who cannot join

Patients who have a documented history of Bipolar I or II disorder, any history of psychosis or pervasive development disorder
Patients with a history of any seizure disorder (other than febrile seizures) or patients who have taken (or are currently taking) anticonvulsants for seizure control are not eligible to participate
Patients at serious suicidal risk as assessed by the investigator
Patients with significant cardiovascular disease or other conditions that could be aggravated by an increased heart rate or increased blood pressure
Patients who have any medical condition that would increase sympathetic nervous system activity markedly (for example, catecholamine-secreting neural tumor), or who are taking a medication on a daily basis (for example, albuterol, inhalation aerosols, pseudoephedrine), that has sympathomimetic activity. Such medications can be taken on an as-needed basis

Trial locations and contacts

20 sites in 1 country.

City, postcode or hospital

20 sites in 1 country

Italy20 sites

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.
Acireale, 95024
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Avellino, 83100
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Bosisio Parini, 23842
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Brescia, 25123
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Catania, 95125
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Coppito, 67100
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Cremona, 26100
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Milan, 20129
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Ostuni, 72017
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Palermo, 90145
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Perugia, 06100
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Rho, 20017
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Rome, 00165
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Sassari, 07100
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Savigliano, 12038
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Siena, 53100
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Trieste, 34137
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Troina, 94018
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.
Udine, 33100
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Viterbo, 01100

Other trials in Italy

About this study

Official title: An Open-Label Study of the Efficacy of Atomoxetine Hydrochloride on Quality of Life of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder With or Without Comorbid Conditions

Conditions: Attention Deficit Disorder With Hyperactivity
Being tested: atomoxetine
Medical subject headings: Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

atomoxetineDrug
Also called LY139603, Strattera
0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks

Study groups in NCT00320528
Study group	Role	What they receive
Pure ADHD	Experimental	Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks Receives: Drug: atomoxetine
ADHD+Internalizing Disorders	Experimental	Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks Receives: Drug: atomoxetine
ADHD+Externalizing Disorders	Experimental	Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks Receives: Drug: atomoxetine

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline to 12 Week Endpoint in Child Health and Illness Profile - Child Edition (CHIP-CE), Achievement Domain
Parent-rated assessment of a child's health status and level of functioning. It consists of 76 items. The majority of items assess frequency of activities or feelings using a five-point response format (for example, 'how good is your child at making friends?' 1=never, 5=always). Standard scores (t-value) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Standard scores are expressed in standard deviation units. Achievement Domain Range = -3.1 to 67.7. Higher scores mean greater health or level of functioning in achievement.
Measured: Baseline, 12 Weeks

Secondary outcomes (9)

Change From Baseline to 12 Week Endpoint in the Attention-Deficit/Hyperactivity Disorder (ADHD) Subscales of 18-Item Swanson, Nolan and Pelham Rating Scale (SNAP-IV)
Items from the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for ADHD are included for the two subsets of symptoms: inattention (items #1-#9: total score=0-27) and hyperactivity/impulsivity (items #11-#19: total score=0-27). The SNAP-IV is based on a 0 (not at all) to 3 (very much) rating scale. Total combined type (inattention plus hyperactivity/impulsivity) subscale scores range from 0 to 54.
Measured: Baseline, 12 Weeks
Change From Baseline to 12 Week Endpoint in Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S)
Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).
Measured: Baseline, 12 Weeks
Change From Baseline to 12 Week Endpoint in CHIP-CE Satisfaction, Comfort, Resilience and Risk Avoidance Domains
Parent-rated assessment of a child's health status and level of functioning. It consists of 76 items. The majority of items assess frequency of activities or feelings using a five-point response format (for example, 'how good is your child at making friends?' 1=never, 5=always). Standard scores (t-value) were established, with all domains having a mean score of 50 and standard deviation of 10. Satisfaction range=-25.7 to 66.3; Comfort=-28.6 to 67.2; Resilience=-36.3 to 71.8; Risk Avoidance=-23.5 to 62.5. Higher scores mean greater health or level of functioning in that domain.
Measured: Baseline, 12 Weeks
Change From Baseline to 12 Week Endpoint in Pediatric Anxiety Rating Scale (PARS)
The Pediatric Anxiety Rating Scale (PARS) is used to rate the severity of anxiety in children and adolescents, ages 6 to 17 years. The total score for the PARS is derived by summing 5 of the 7 severity/impairment/interference items (2,3,5,6,7). The total score ranges from 0 (none) to 25 (extreme severity). Items 1 (overall number of anxiety symptoms) and 4 (overall severity of physical symptoms) are not included in the total score calculation.
Measured: Baseline, 12 Weeks
Change From Baseline to 12 Week Endpoint in Children's Depression Rating Scale-Revised (CDRS-R)
Measures presence and severity of depression. Consists of 17 items scored on a 1-5 or 1-7 scale. A rating of 1 indicates normal, thus the minimum score is 17. The maximum score is 113. In general, scores below 20 indicate an absence of depression; scores of 20 or 30 indicate borderline depression; scores of 40 to 60 indicate moderate depression.
Measured: Baseline, 12 Weeks
Change From Baseline to 12 Week Endpoint in SNAP-IV Oppositional Scale
Items are included from the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for Oppositional Defiant Disorder. The SNAP-IV is based on a 0 (not at all) to 3 (very much) rating scale. Total subscale scores range from 0 to 24.
Measured: Baseline, 12 Weeks
Change From Baseline to 12 Week Endpoint in Adolescent Symptom Inventory-4: Parent Checklist (ASI-4)
Parent-completed ASI-4 contains 120 items on 18 emotional and behavioral disorders in adolescents (12-18 years old). Item score range:0 (no symptoms) to 3 (maximum impairment). Categories: A=ADHD (0-54); B=Conduct (0-60); C=Oppositional Defiant (0-24); D=Generalized Anxiety (0-18); E=Specific Phobia/Panic Attack/Obsessions/Compulsions/Somatization (0-30); F=Social Phobia (0-6); G=Separation Anxiety (0-24); H=Schizoid Personality (0-9); I=Schizophrenia (0-6); J=Enuresis (0-18); K=Major Depressive (0-42); L=Bipolar (0-27); M=Anorexia (0-12); N=Bulimia (0-12); O=Substance Abuse (0-18).
Measured: Baseline, 12 Weeks
Change From Baseline to 12 Week Endpoint in Child Symptom Inventory-4: Parent Checklist (CSI-4)
The CSI-4 contains 97 items that screen for 15 emotional and behavioral disorders in children between 5 and 12 years old. Item score range:0 (no symptoms) to 3 (maximum impairment). Categories: A=ADHD (0-54); B=Conduct (0-60); C=Oppositional Defiant (0-24); D=Generalized Anxiety (0-18); E=Specific Phobia/Panic Attack/Obsessions/Compulsions/Somatization (0-30); F=Social Phobia (0-6); G=Separation Anxiety (0-24); H=Schizoid Personality (0-9); I=Schizophrenia (0-6); J=Enuresis (0-18).
Measured: Baseline, 12 Weeks
Change From Baseline to 12 Week Endpoint in Conners' Teacher Rating Scale-Revised: Short Form (CTRS-R:S)
A 28-item rating scale (0 [not at all/never] to 3 [very much true/very often]) completed by the teacher to assess problem behaviors related to ADHD. Subscale total scores range from 0 to 15 for Oppositional and Cognitive Problems, 0 to 21 for Hyperactivity, and 0 to 36 for ADHD Index.
Measured: Baseline, 12 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2006Oct 2008

First posted3 May 2006 (estimated)
Study startApr 2006
Primary completionOct 2008
Study completionOct 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 269 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00320528
Sponsor's protocol ID: 9867
Other IDs: B4Z-IT-LYDS
Status last verified: Dec 2009
First submitted: 28 Apr 2006
Last updated: 6 Jan 2010
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD
RecruitingPhase 3
A Study to Test the Effects of Centanafadine in Adults With Attention-deficit/Hyperactivity Disorder and Emotional Dysregulation
Attention-deficit/Hyperactivity Disorder, Emotional Dysregulation

All Attention Deficit Disorder With Hyperactivity trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label Study of the Efficacy of Atomoxetine Hydrochloride on Quality of Life of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder With or Without Comorbid Conditions
ClinicalTrials.gov ID: NCT00320528
Acronym / sponsor ID: 9867
Conditions: Attention Deficit Disorder With Hyperactivity
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 269 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Apr 2006
Primary completion: Oct 2008 (actual)
Study completion: Oct 2008 (actual)
First posted: 3 May 2006 (estimated)
Results: Posted 6 Jan 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Pure ADHD	Experimental	Drug: atomoxetineAttention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
ADHD+Internalizing Disorders	Experimental	Drug: atomoxetineAttention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
ADHD+Externalizing Disorders	Experimental	Drug: atomoxetineAttention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks

Who may qualify

Ages: 6 to 15 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

Child or adolescent patients, male or female outpatients, who are at least 6 years of age, but must not yet have reached their 16th birthday prior to Visit 1, when informed consent is obtained
Patients must meet Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) diagnostic criteria for ADHD (any subtype) and score at least 1.5 standard deviations above the age norm for their diagnostic subtype using published norms for the Swanson, Nolan and Pelham Questionnaire: Attention-Deficit/Hyperactivity Disorder Subscale (SNAP-IV ADHD Subscale) score at both Visit 1 and 2
Laboratory results, including serum chemistries, hematology, and urinalysis, must show no clinically significant abnormalities (clinically significant is defined as laboratory values requiring acute medical intervention, indicating a serious medical illness, or requiring further medical evaluation in the judgment of the investigator)
An electrocardiogram (ECG) must be performed to exclude cardiac diseases at the baseline/screening visit and the results must be reviewed by the investigator at Visit 2 prior to dispensing of study material
Patients and parents have been judged by the investigator to be reliable to keep appointments for clinic visits and all tests, including venipuncture, and examinations required by the protocol.

Key exclusion criteria (5 listed)

Patients who have a documented history of Bipolar I or II disorder, any history of psychosis or pervasive development disorder
Patients with a history of any seizure disorder (other than febrile seizures) or patients who have taken (or are currently taking) anticonvulsants for seizure control are not eligible to participate
Patients at serious suicidal risk as assessed by the investigator
Patients with significant cardiovascular disease or other conditions that could be aggravated by an increased heart rate or increased blood pressure
Patients who have any medical condition that would increase sympathetic nervous system activity markedly (for example, catecholamine-secreting neural tumor), or who are taking a medication on a daily basis (for example, albuterol, inhalation aerosols, pseudoephedrine), that has sympathomimetic activity. Such medications can be taken on an as-needed basis

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
atomoxetineAlso: LY139603, Strattera0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks	Drug	ADHD+Externalizing Disorders, ADHD+Internalizing Disorders, Pure ADHD

Primary outcome

Change From Baseline to 12 Week Endpoint in Child Health and Illness Profile - Child Edition (CHIP-CE), Achievement Domain
Time frame: Baseline, 12 Weeks
Parent-rated assessment of a child's health status and level of functioning. It consists of 76 items. The majority of items assess frequency of activities or feelings using a five-point response format (for example, 'how good is your child at making friends?' 1=never, 5=always). Standard scores (t-value) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Standard scores are expressed in standard deviation units. Achievement Domain Range = -3.1 to 67.7. Higher scores mean greater health or level of functioning in achievement.

9 secondary outcomes

Change From Baseline to 12 Week Endpoint in the Attention-Deficit/Hyperactivity Disorder (ADHD) Subscales of 18-Item Swanson, Nolan and Pelham Rating Scale (SNAP-IV)
Time frame: Baseline, 12 Weeks
Change From Baseline to 12 Week Endpoint in Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S)
Time frame: Baseline, 12 Weeks
Change From Baseline to 12 Week Endpoint in CHIP-CE Satisfaction, Comfort, Resilience and Risk Avoidance Domains
Time frame: Baseline, 12 Weeks
Change From Baseline to 12 Week Endpoint in Pediatric Anxiety Rating Scale (PARS)
Time frame: Baseline, 12 Weeks
Change From Baseline to 12 Week Endpoint in Children's Depression Rating Scale-Revised (CDRS-R)
Time frame: Baseline, 12 Weeks
Change From Baseline to 12 Week Endpoint in SNAP-IV Oppositional Scale
Time frame: Baseline, 12 Weeks
Change From Baseline to 12 Week Endpoint in Adolescent Symptom Inventory-4: Parent Checklist (ASI-4)
Time frame: Baseline, 12 Weeks
Change From Baseline to 12 Week Endpoint in Child Symptom Inventory-4: Parent Checklist (CSI-4)
Time frame: Baseline, 12 Weeks
Change From Baseline to 12 Week Endpoint in Conners' Teacher Rating Scale-Revised: Short Form (CTRS-R:S)
Time frame: Baseline, 12 Weeks

Results and safety

Results posted to the registry on 6 Jan 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pure ADHD	98	87
ADHD+Internalizing Disorders	41	31
ADHD+Externalizing Disorders	130	108

Primary outcome: Change From Baseline to 12 Week Endpoint in Child Health and Illness Profile - Child Edition (CHIP-CE), Achievement Domain

Time frame: Baseline, 12 Weeks. Mean (95% Confidence Interval). Unit: T-Score

Measure	Pure ADHD n = 83	ADHD+Internalizing Disorders n = 28	ADHD+Externalizing Disorders n = 97
Value	2.65 (0.93 to 4.37)	0.51 (-1.38 to 2.39)	3.89 (2.22 to 5.57)

Population analysed: Number of patients with baseline and at least one nonmissing post-baseline measurement.

9 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pure ADHD	1 of 97 (1%)	76 of 97 (78.4%)	Not reported
ADHD+Internalizing Disorders	0 of 38 (0%)	29 of 38 (76.3%)	Not reported
ADHD+Externalizing Disorders	2 of 128 (1.6%)	94 of 128 (73.4%)	Not reported

Limitations and caveats (from the sponsor): The original intent was to also calculate change and 95% confidence intervals at end of Period III; however, due to low number of patients completing Period III, variations from baseline (LOCF), are not suitable for further analysis or description.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Lilly Clinical Trial RegistryLink provided by the sponsor.

Related trials for Attention Deficit Disorder With Hyperactivity

Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD
RecruitingPhase 3
A Study to Test the Effects of Centanafadine in Adults With Attention-deficit/Hyperactivity Disorder and Emotional Dysregulation
Attention-deficit/Hyperactivity Disorder, Emotional Dysregulation

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

20 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing atomoxetine in people with Attention Deficit Disorder With Hyperactivity, run by Eli Lilly and Company at 20 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jan 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline to 12 Week Endpoint in Child Health and Illness Profile - Child Edition (CHIP-CE), Achievement Domain (time frame: Baseline, 12 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00320528.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2010.