Attention Deficit Hyperactivity DisorderPhase 2NCT00636818
Atomoxetine Asian Study in Adult Subjects With Attention-Deficit/Hyperactivity Disorder (ADHD)
A Phase 2 study testing Atomoxetine in people with Attention Deficit Hyperactivity Disorder, run by Eli Lilly and Company at 11 sites in 3 countries.
Trial summary
The primary objective of this clinical study is to assess overall safety and tolerability as measured by discontinuation rate due to adverse events in doses up to 120 mg/day in relation to global clinical studies in adult subjects who meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV™)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Atomoxetine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 11 sitesin 3 countries
- Study dates
- Mar 2008to Oct 2008
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 18 years of age
- meet Conners' Adult ADHD Diagnostic Interview for DSM-IV (CAADID) diagnostic criteria for current ADHD as well as meeting criteria for a historical diagnosis of ADHD during childhood
- have a Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S) score of 4 (moderate symptoms) or greater
Who cannot join
- Patients who meet DSM-IV diagnostic criteria for current major depression and also patients who have total score of more than 12 on the 17-item Hamilton Depression Rating Scale (HAMD-17) at Visit 1 and Visit 2. Patients who have both a current or past history of major depression and have received any anti-depression drug therapy within 6 months of Visit 1.
- Patients who meet DSM-IV diagnostic criteria for have a current anxiety disorder and also require anti-anxiety drug therapy except for those taking benzodiazepines analogues for anxiety which need to be limited.
- Patients who have any history of bipolar disorder (DSM-IV) , any history of schizophrenia or any history of a psychotic disorder (DSM-IV) will be excluded from the study.
- Patients who have been diagnosed (DSM-IV) with a pervasive developmental disorder.
Trial locations and contacts
11 sites in 3 countries.
11 sites in 3 countries
South Korea4 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.
Busan, 602739
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.
Incheon, 405-760
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.
Jeonju, 561-712
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.
Seoul, 120-752
Taiwan4 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.
Neihu Taipei, 114
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.
Niao Sung Hsiang, 833
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.
Taipei, 100
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.
Taoyuan, 333
China3 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.
Beijing, 100088
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.
Changsha, 410011
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.
Guangzhou, 560370
About this study
Official title: An Open Study of Atomoxetine (LY139603) in Adult Subjects With Attention-deficit/Hyperactivity Disorder
The primary objective of this clinical study is to assess overall safety and tolerability as measured by discontinuation rate due to adverse events in doses up to 120 mg/day in relation to global clinical studies in adult subjects who meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV™) criteria for Attention-Deficit/Hyperactivity Disorder (ADHD).
- Conditions
- Attention Deficit Hyperactivity Disorder
- 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
Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
| Study group | Role | What they receive |
|---|---|---|
| Atomoxetine | Experimental | Not described Receives: Drug: Atomoxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discontinuations Due to Adverse Events (AE)
The definition of a study adverse event was any unfavorable medical event, newly emerged or a deterioration of a preexisting condition, in other words any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship, that occurred after the visit for informed consent and up to the visit for completion of administration, or discontinuation.
Measured: Baseline to 8 Weeks
Secondary outcomes (11)
Change From Baseline to 8 Week Endpoint in Conners' Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale-Investigator Rated:Screening Version (CAARS-Inv:SV) Total ADHD Symptom Score
Conners' Adult Attention-Deficit Hyperactivity Disorder (ADHD) Rating Scale-Investigator Rating:Screening Version. Total ADHD symptom score consisted of 18 items (sum of inattention and hyperactivity-impulsivity subscales) using a 4-point scale (0=not at all/never to 3=very much/very frequently) for total score range of 0 to 54.
Measured: Baseline and 8 Weeks
Change From Baseline to 8 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 and 8 Weeks
Change From Baseline to 8 Week Endpoint in Conners' Adult ADHD Rating Scale-Self Rated:Screening Version (CAARS-S:SV) Total ADHD Symptom Score
Conners' Adult Attention-Deficit Hyperactivity Disorder (ADHD) Rating Scale-Self Rating:Screening Version. Total ADHD symptom score consisted of 18 items (sum of inattention and hyperactivity-impulsivity subscales) using a 4-point scale (0=not at all/never to 3=very much/very frequently) for total score range of 0 to 54.
Measured: Baseline and 8 Weeks
Change From Baseline to 8 Week Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17)
The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).
Measured: Baseline and 8 Weeks
Change From Baseline to 8 Week Endpoint in Hamilton Anxiety Rating Scale (HAMA-14)
The HAMA-14 scale measures anxiety symptoms accompanying Major Depressive Disorder (MDD). Each item of the 14-item HAMA was scored from 0 (not present) to 4 (very severe), with a resulting maximum total score of 56.
Measured: Baseline and 8 Weeks
Change From Baseline to 8 Week Endpoint in Stroop Color Word Test
This was a psychological test to observe the interference in which disparity between the meaning and color affects reading speed. A subject was given 3 tasks of recognition: reading the printed colored ink (Color Test), reading color words in black ink (Word Test), and interference, reading color words printed in different colored ink (Word-Color Test). The test was scored on the number of correct answers. There were 100 items for each of the three categories and if they made it through the 100 words with time remaining, they would repeat the list.
Measured: Baseline and 8 Weeks
Change From Baseline to 8 Week Endpoint in Short Form-36 Version 2 (SF-36v2)
SF-36 assesses quality of life (QoL) on 8 domains and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). MCS and PCS scores=0-100 (higher scores indicate better QoL). Raw domain scores: general health=5-25; physical functioning=10-30; role-physical=4-20; role-emotional=3-15; social functioning=2-10; bodily pain=2-12; vitality=4-20; mental health=5-25. Using norm based scores, all domains, MCS and PCS scores have average score of 50 with standard deviation of 10. Norm-based score=Z-score*10+50 in each subscale. Range cannot be specified in norm-based scores.
Measured: Baseline and 8 Weeks
Number of Participants With Potentially Clinically Significant Changes in Vital Signs During the Study
Vital signs reported are Pulse (beats per minute [bpm]), Systolic Blood Pressure (SBP) (mmHg), and Diastolic Blood Pressure (DBP) (mmHg).
Measured: Baseline to 8 Weeks
Significant Changes in Body Weight During the Study
Potentially clinically significant weight loss was defined as any decrease of at least 7 percent (%). Potentially clinically significant weight gain was defined as any increase of at least 7%.
Measured: Baseline to 8 Weeks
Number of Participants With Abnormal QTc Interval Based on International Conference on Harmonisation Criterion
The Fridericia correction of the QT interval (QTcF) was used.
Measured: Baseline to 8 Weeks
Cytochrome P450 2D6 (CYP2D6) Phenotype Status
CYP2D6 is the primary atomoxetine metabolizing enzyme. Metabolizzer status was determined by focusing on the normal, decreased, and defective allele. Poor metabolizer = defective/defective. Extensive metabolizer is all except for poor metabolizer.
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionSep 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 Hyperactivity DisorderStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) Mon - Fri 9 AM - 5PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00636818
- Sponsor's protocol ID
- 12112
- Other IDs
- B4Z-JE-LYEH
- Status last verified
- Oct 2010
- First submitted
- 7 Mar 2008
- Last updated
- 4 Nov 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Study of Atomoxetine (LY139603) in Adult Subjects With Attention-deficit/Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT00636818
- Acronym / sponsor ID
- 12112
- Conditions
- Attention Deficit Hyperactivity Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 14 Mar 2008 (estimated)
- Results
- Posted 23 Dec 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this clinical study is to assess overall safety and tolerability as measured by discontinuation rate due to adverse events in doses up to 120 mg/day in relation to global clinical studies in adult subjects who meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV™) criteria for Attention-Deficit/Hyperactivity Disorder (ADHD).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atomoxetine | Experimental | Drug: Atomoxetine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- at least 18 years of age
- meet Conners' Adult ADHD Diagnostic Interview for DSM-IV (CAADID) diagnostic criteria for current ADHD as well as meeting criteria for a historical diagnosis of ADHD during childhood
- have a Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S) score of 4 (moderate symptoms) or greater
Key exclusion criteria (4 listed)
- Patients who meet DSM-IV diagnostic criteria for current major depression and also patients who have total score of more than 12 on the 17-item Hamilton Depression Rating Scale (HAMD-17) at Visit 1 and Visit 2. Patients who have both a current or past history of major depression and have received any anti-depression drug therapy within 6 months of Visit 1.
- Patients who meet DSM-IV diagnostic criteria for have a current anxiety disorder and also require anti-anxiety drug therapy except for those taking benzodiazepines analogues for anxiety which need to be limited.
- Patients who have any history of bipolar disorder (DSM-IV) , any history of schizophrenia or any history of a psychotic disorder (DSM-IV) will be excluded from the study.
- Patients who have been diagnosed (DSM-IV) with a pervasive developmental disorder.
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, StratteraStudy drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability. | Drug | Atomoxetine |
Primary outcome
Discontinuations Due to Adverse Events (AE)
Time frame: Baseline to 8 Weeks
The definition of a study adverse event was any unfavorable medical event, newly emerged or a deterioration of a preexisting condition, in other words any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship, that occurred after the visit for informed consent and up to the visit for completion of administration, or discontinuation.
11 secondary outcomes
Change From Baseline to 8 Week Endpoint in Conners' Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale-Investigator Rated:Screening Version (CAARS-Inv:SV) Total ADHD Symptom Score
Time frame: Baseline and 8 Weeks
Change From Baseline to 8 Week Endpoint in Clinical Global Impressions-ADHD Severity (CGI-ADHD-S)
Time frame: Baseline and 8 Weeks
Change From Baseline to 8 Week Endpoint in Conners' Adult ADHD Rating Scale-Self Rated:Screening Version (CAARS-S:SV) Total ADHD Symptom Score
Time frame: Baseline and 8 Weeks
Change From Baseline to 8 Week Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17)
Time frame: Baseline and 8 Weeks
Change From Baseline to 8 Week Endpoint in Hamilton Anxiety Rating Scale (HAMA-14)
Time frame: Baseline and 8 Weeks
Change From Baseline to 8 Week Endpoint in Stroop Color Word Test
Time frame: Baseline and 8 Weeks
Change From Baseline to 8 Week Endpoint in Short Form-36 Version 2 (SF-36v2)
Time frame: Baseline and 8 Weeks
Number of Participants With Potentially Clinically Significant Changes in Vital Signs During the Study
Time frame: Baseline to 8 Weeks
Significant Changes in Body Weight During the Study
Time frame: Baseline to 8 Weeks
Number of Participants With Abnormal QTc Interval Based on International Conference on Harmonisation Criterion
Time frame: Baseline to 8 Weeks
Cytochrome P450 2D6 (CYP2D6) Phenotype Status
Time frame: 8 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Attention Deficit Hyperactivity Disorder
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
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
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) Mon - Fri 9 AM - 5PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
11 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atomoxetine in people with Attention Deficit Hyperactivity Disorder, run by Eli Lilly and Company at 11 sites in 3 countries.
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 3 inclusion and 4 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 4 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in South Korea, Taiwan, China. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 23 Dec 2009). 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?
Discontinuations Due to Adverse Events (AE) (time frame: Baseline to 8 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2010.