Attention Deficit Disorder With HyperactivityPhase 4NCT00183391
Stimulant Versus Nonstimulant Medication for Attention Deficit Hyperactivity Disorder in Children
A Phase 4 study testing Atomoxetine and Methylphenidate in people with Attention Deficit Disorder With Hyperactivity, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.
Trial summary
This study will determine the effectiveness of stimulant and nonstimulant medication in treating the symptoms of attention deficit hyperactivity disorder (ADHD) in children and adolescents. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- What is being tested?
- Atomoxetine and Methylphenidate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2005to Jun 2011
- Phase
- Phase 4
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Meets DSM-IV-TR criteria for ADHD
- Scores at least 1.5 standard deviation higher than age and gender mean on ADHD-RS keyed to ADHD subtype
- CGI Severity ADHD Rating greater than or equal to 4
- Currently attends school with at least 3 months left in high school
- Currently lives at home with parent(s) or legal guardian(s), now and for the past year before study entry, and is expected to remain there
- Normal physical exam, laboratory tests, and electrocardiogram
Show all 11Show fewer
- Pulse and blood pressure within 95% of age and gender mean
- Full Scale IQ is greater than or equal to 75 OR if the results of testing indicate that Full Scale IQ is not a good indicator of intellectual ability, a General Ability Index greater than or equal to 75
- Weight is between 20 and 85 kilograms
- Able to swallow pills
- Parent or guardian willing to provide informed consent
Who cannot join
- History of atomoxetine or methylphenidate intolerance
- Any existing medical condition for which study medications are contraindicated
- If the child is in psychotherapy, no changes in therapy expected during the study trial
- Presence of any of the following: autism, mental retardation, schizophrenia, a psychotic disorder, bipolar disorder, severe depression, or conduct disorder
- Presence of a comorbid disorder that should be the primary focus of treatment
- Presence of a medical or neurological disorder precluding study medications or assessing ADHD
Show all 11Show fewer
- Allergic reactions to multiple medications
- History of alcohol or drug abuse in the 3 months before study entry, or positive urine toxic screen that is not explained by a time limited medical circumstance
- Involved in a medication treatment study in the 30 days before study entry
- Female who is sexually active and is unwilling to use birth control
- Evidence of child abuse or neglect
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Illinois, Chicago - Institute for Juvenile Research
Chicago, Illinois, 60612
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Measuring and Predicting Response to Atomoxetine and Methylphenidate
This study will determine the effectiveness of stimulant and nonstimulant medication in treating the symptoms of attention deficit hyperactivity disorder (ADHD) in children and adolescents.
Read the detailed description
ADHD is one of the most frequently occurring disorders of children and adolescents and is a significant public health problem. The most common treatment for the condition is stimulant medication. However, there are an increasing number of children who are experiencing negative side effects from stimulants, such as dizziness, loss of appetite, and headaches; these side effects have made the need for alternative treatments all the more important. This study will compare the stimulant methylphenidate to the nonstimulant atomoxetine to determine which is more effective in treating ADHD symptoms in children and adolescents. The two medications differ in the neurotransmitters they influence. Stimulants such as methylphenidate act upon the neurotransmitter dopamine, while atomoxetine works on norepinephrine. It has been proposed that the difference in neurotransmitter stimulation may result in differences in an ADHD patient's response to treatment.
Participants will be randomly assigned to receive either methylphenidate or atomoxetine for between 4 to 6 weeks, depending on how soon they respond to the treatment. After the 4 to 6 week period, participants will be crossed-over to receive whichever medication they did not receive in the first part of the study.
Participants will have up to 14 weekly study visits. Over the first two visits, participants will undergo psychological and intelligence tests, a medical history, an electrocardiogram, blood and urine collection, and a physical exam. The remaining visits will occur weekly. During these visits, participants will receive their assigned medication and, along with their parents, will complete questionnaires about their response to treatment and any side effects they may be experiencing. The teachers of all participants will be asked to complete a questionnaire about their student's behavior at 4 different times during the study. Participant, parent, and teacher questionnaires will be used to assess the ADHD symptoms of participants, as well as self-report clinical scales completed by the participants.
- Being tested
- Atomoxetine, Methylphenidate
- Keywords
- ADHD, Child, Adolescent, School
- 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
Participants will be randomly assigned to receive either methylphenidate or atomoxetine for either 2 or 5 weeks, depending on how soon they respond to the treatment. After the 2- or 5-week period, participants will be crossed-over to receive whichever medication they did not receive in the first part of the study.
MethylphenidateDrug
Participants will be randomly assigned to receive either methylphenidate or atomoxetine for either 2 or 5 weeks, depending on how soon they respond to the treatment. After the 2- or 5-week period, participants will be crossed-over to receive whichever medication they did not receive in the first part of the study.
| Study group | Role | What they receive |
|---|---|---|
| Atomoxetine | Active comparator | Participants will receive treatment for ADHD with the non-stimulant atomoxetine Receives: Drug: Atomoxetine; Drug: Methylphenidate |
| Methylphenidate | Active comparator | Participants will receive treatment for ADHD with the stimulant methylphenidate Receives: Drug: Atomoxetine; Drug: Methylphenidate |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADHD-RS Total Score
ADHD-RS Total Score Attention Deficit Hyperactivity Disorder Rating Scale. Each item on the 18-item measure is scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms), yielding a possible total score of 0-54. Higher score indicates higher probability of diagnosis.
Measured: up to 14 weeks
Secondary outcomes (25)
Treatment Preference Survey
Measured: Measured at ends of treatments one and two
ADHD - H/I
Attention deficit/hyperactivity disorder - hyperactivity/impulsivity (ADHD- H/I). Each item on the 18-item measure is scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms), yielding a possible total score of 0-27. Higher score indicates higher probability of diagnosis.
Measured: up to 14 weeks
ADHD-RS Inattention
Each item on the 18-item measure is scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms), yielding a possible total score of 0-27. Higher score indicates higher probability of diagnosis.
Measured: up to 14 weeks
Clinical Global Impressions (CGI)- Severity
The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.
Measured: up to 14 weeks
Social Skills Rating Scale (SSRS)- Parent Version
Measure of social skills, higher score is better. This scale is based on t-scores and does not have psychometrics available.
Measured: up to 14 weeks
Child Conflict Index (CCI)
Measure of conflict within the home over the past 24 hours. The CCI is a validated measure of family conflicts in the home and is completed by parents. It consists of 42 items (for boys) or 36 items (for girls) reflecting attention-seeking and conflictual behavior, as well as negativity and withdrawal. Items are scored as yes (1 point) or no (0 points). Mean score between 0 and 1 reported, with higher score indicating greater conflict.
Measured: up to 14 weeks
Continuous Performance Test (CPT)
CPT Commissions, impulsive responses, higher score is worse. This scale is based on t-scores and does not have psychometrics available.
Measured: up to 14 weeks
Children's Sleep Questionnaire
Children's Sleep Problems Severity, sum of scores, higher is worse.The scale assessed contains 16 items, each scored 0 to 3, with 0 representing no problems and 3 representing daily problems. total range from 0 to 48. This score does not have psychometrics available.
Measured: up to 14 weeks
Assessment of Affective Range (AAR)
Affective problems. This scale consists of 8 items, scored 0-3, with 0 representing no problems and 3 representing extreme problems. This analysis presents sum of scores, higher is worse. Full range from 0 to 24. This score does not have psychometrics available.
Measured: up to 14 weeks
Tics: Total Motor
Modified Yale Global Tic Severity Scale, sum, higher is worse. This score does not have psychometrics available. The Yale Global Tic Severity Scale (YGTSS) is a semistructured clinician-rated instrument that assesses the severity and frequency of motor and phonic tics over the previous week. Five index scores are obtained during the assessment, where higher scores indicate greater frequency or severity. These indices are: Total Motor Tic Score (0-25), Total Phonic Tic Score (0-25), Total Tic Score (0-50) Overall Impairment Rating (0-50).
Measured: up to 14 weeks
Tics: Total Phonic
Modified Yale Global Tic Severity Scale, sum, higher is worse. This score does not have psychometrics available. The Yale Global Tic Severity Scale (YGTSS) is a semistructured clinician-rated instrument that assesses the severity and frequency of motor and phonic tics over the previous week. Five index scores are obtained during the assessment, where higher scores indicate greater frequency or severity. These indices are: Total Motor Tic Score (0-25), Total Phonic Tic Score (0-25), Total Tic Score (0-50) Overall Impairment Rating (0-50).
Measured: up to 14 weeks
Tics: Total Impairment
Modified Yale Global Tic Severity Scale, sum, higher is worse. This score does not have psychometrics available. The Yale Global Tic Severity Scale (YGTSS) is a semistructured clinician-rated instrument that assesses the severity and frequency of motor and phonic tics over the previous week. Five index scores are obtained during the assessment, where higher scores indicate greater frequency or severity. These indices are: Total Motor Tic Score (0-25), Total Phonic Tic Score (0-25), Total Tic Score (0-50) Overall Impairment Rating (0-50).
Measured: up to 14 weeks
Vital Signs - Systolic Blood Pressure
Systolic blood pressure - the amount of pressure in arteries during contraction of the heart muscle Normal range varies by age, sex, height and weight and can range from 80mm Hg to 130mmHg
Measured: up to 14 weeks
Vital Signs - Diastolic Blood Pressure
Diastole blood pressure - blood pressure when the heart muscle is between beats. normal range varies by age, sex, height and weight and can range from 34mm Hg to 90mmHg
Measured: up to 14 weeks
Vital Signs - Pulse
Heartbeats per minute. Range varies from 50-205 depending on age and level of activity.
Measured: up to 14 weeks
SES (Hollingshead)
Measure of socioeconomic status, score calculated from averaging likert responses, lower = worse
Measured: up to 14 weeks
Conners-Wells Adolescent Self Report
Standardized measure of ADHD symptoms and severity, norm referenced T scores, higher = worse
Measured: up to 14 weeks
Conners Teacher Rating Scale- Short
Standardized measure of ADHD symptoms and severity, norm referenced T scores, higher = worse
Measured: up to 14 weeks
Child Behavior Checklist (CBCL)
CBCL Total Score, measure of psychosocial problems, higher is worse.
Measured: Measured at screening
Social Skills Rating Scale (SSRS)- Teacher Version
Measure of social skills, higher score is better. This scale is based on t-scores and does not have psychometrics available.
Measured: up to 14 weeks
Permanent Mathematics Product Test (PERMP)
Measure of fluency in performance of simple mathematics, sum, lower = worse
Measured: up to 14 weeks
Actigraphy
Measure of physical activity
Measured: Measured daily throughout the study
Sleep Logs
Questionnaire, qualitative
Measured: Measured daily throughout the study
Hyperactivity, Attention, and Learning Problems (HALP) Medical and Developmental History Questionnaire
Questionnaire, qualitative designed to collect family history, prenatal environmental influences, and developmental history.
Measured: Measured at screening
HALP Rebound Effects Questionnaire
Questionnaire, qualitative assesses symptoms of rebound (moodiness, irritability, aggression, and ADHD symptoms) when the medication wears off at night.
Measured: up to 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJul 2005
- Primary completionJun 2011
- Study completionJun 2011
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Jeffrey Newcorn, Icahn School of Medicine at Mount Sinai
- Investigators
- Jeffrey H. Newcorn, MD, Principal investigator, Icahn School of Medicine at Mount SinaiMark A. Stein, PhD, Principal investigator, University of Illinois, Chicago - Institute for Juvenile Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00183391
- Sponsor's protocol ID
- GCO 03-0612-00002
- Other IDs
- R01MH070935, R01MH070564, DSIR 84-CTM
- Status last verified
- May 2018
- First submitted
- 13 Sep 2005
- Last updated
- 6 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Bedard AC, Stein MA, Halperin JM, Krone B, Rajwan E, Newcorn JH. Differential impact of methylphenidate and atomoxetine on sustained attention in youth with attention-deficit/hyperactivity disorder. J Child Psychol Psychiatry. 2015 Jan;56(1):40-8. doi: 10.1111/jcpp.12272. Epub 2014 Jun 19.
PubMed 24942409Schulz KP, Bedard AV, Fan J, Hildebrandt TB, Stein MA, Ivanov I, Halperin JM, Newcorn JH. Striatal Activation Predicts Differential Therapeutic Responses to Methylphenidate and Atomoxetine. J Am Acad Child Adolesc Psychiatry. 2017 Jul;56(7):602-609.e2. doi: 10.1016/j.jaac.2017.04.005. Epub 2017 May 10.
PubMed 28647012
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring and Predicting Response to Atomoxetine and Methylphenidate
- ClinicalTrials.gov ID
- NCT00183391
- Acronym / sponsor ID
- GCO 03-0612-00002
- Keywords
- ADHD, Child, Adolescent, School
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jul 2005
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Posted 6 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine the effectiveness of stimulant and nonstimulant medication in treating the symptoms of attention deficit hyperactivity disorder (ADHD) in children and adolescents.
Detailed description
ADHD is one of the most frequently occurring disorders of children and adolescents and is a significant public health problem. The most common treatment for the condition is stimulant medication. However, there are an increasing number of children who are experiencing negative side effects from stimulants, such as dizziness, loss of appetite, and headaches; these side effects have made the need for alternative treatments all the more important. This study will compare the stimulant methylphenidate to the nonstimulant atomoxetine to determine which is more effective in treating ADHD symptoms in children and adolescents. The two medications differ in the neurotransmitters they influence. Stimulants such as methylphenidate act upon the neurotransmitter dopamine, while atomoxetine works on norepinephrine. It has been proposed that the difference in neurotransmitter stimulation may result in differences in an ADHD patient's response to treatment.
Participants will be randomly assigned to receive either methylphenidate or atomoxetine for between 4 to 6 weeks, depending on how soon they respond to the treatment. After the 4 to 6 week period, participants will be crossed-over to receive whichever medication they did not receive in the first part of the study.
Participants will have up to 14 weekly study visits. Over the first two visits, participants will undergo psychological and intelligence tests, a medical history, an electrocardiogram, blood and urine collection, and a physical exam. The remaining visits will occur weekly. During these visits, participants will receive their assigned medication and, along with their parents, will complete questionnaires about their response to treatment and any side effects they may be experiencing. The teachers of all participants will be asked to complete a questionnaire about their student's behavior at 4 different times during the study. Participant, parent, and teacher questionnaires will be used to assess the ADHD symptoms of participants, as well as self-report clinical scales completed by the participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atomoxetine | Active comparator | Drug: Atomoxetine, Drug: MethylphenidateParticipants will receive treatment for ADHD with the non-stimulant atomoxetine |
| Methylphenidate | Active comparator | Drug: Atomoxetine, Drug: MethylphenidateParticipants will receive treatment for ADHD with the stimulant methylphenidate |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Meets DSM-IV-TR criteria for ADHD
- Scores at least 1.5 standard deviation higher than age and gender mean on ADHD-RS keyed to ADHD subtype
- CGI Severity ADHD Rating greater than or equal to 4
- Currently attends school with at least 3 months left in high school
- Currently lives at home with parent(s) or legal guardian(s), now and for the past year before study entry, and is expected to remain there
Key exclusion criteria (11 listed)
- History of atomoxetine or methylphenidate intolerance
- Any existing medical condition for which study medications are contraindicated
- If the child is in psychotherapy, no changes in therapy expected during the study trial
- Presence of any of the following: autism, mental retardation, schizophrenia, a psychotic disorder, bipolar disorder, severe depression, or conduct disorder
- Presence of a comorbid disorder that should be the primary focus of treatment
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 |
|---|---|---|
| AtomoxetineParticipants will be randomly assigned to receive either methylphenidate or atomoxetine for either 2 or 5 weeks, depending on how soon they respond to the treatment. After the 2- or 5-week period, participants will be crossed-over to receive whichever medication they did not receive in the first part of the study. | Drug | Atomoxetine, Methylphenidate |
| MethylphenidateParticipants will be randomly assigned to receive either methylphenidate or atomoxetine for either 2 or 5 weeks, depending on how soon they respond to the treatment. After the 2- or 5-week period, participants will be crossed-over to receive whichever medication they did not receive in the first part of the study. | Drug | Atomoxetine, Methylphenidate |
Primary outcome
ADHD-RS Total Score
Time frame: up to 14 weeks
ADHD-RS Total Score Attention Deficit Hyperactivity Disorder Rating Scale. Each item on the 18-item measure is scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms), yielding a possible total score of 0-54. Higher score indicates higher probability of diagnosis.
25 secondary outcomes
Treatment Preference Survey
Time frame: Measured at ends of treatments one and two
ADHD - H/I
Time frame: up to 14 weeks
ADHD-RS Inattention
Time frame: up to 14 weeks
Clinical Global Impressions (CGI)- Severity
Time frame: up to 14 weeks
Social Skills Rating Scale (SSRS)- Parent Version
Time frame: up to 14 weeks
Child Conflict Index (CCI)
Time frame: up to 14 weeks
Continuous Performance Test (CPT)
Time frame: up to 14 weeks
Children's Sleep Questionnaire
Time frame: up to 14 weeks
Assessment of Affective Range (AAR)
Time frame: up to 14 weeks
Tics: Total Motor
Time frame: up to 14 weeks
Tics: Total Phonic
Time frame: up to 14 weeks
Tics: Total Impairment
Time frame: up to 14 weeks
Vital Signs - Systolic Blood Pressure
Time frame: up to 14 weeks
Vital Signs - Diastolic Blood Pressure
Time frame: up to 14 weeks
Vital Signs - Pulse
Time frame: up to 14 weeks
SES (Hollingshead)
Time frame: up to 14 weeks
Conners-Wells Adolescent Self Report
Time frame: up to 14 weeks
Conners Teacher Rating Scale- Short
Time frame: up to 14 weeks
Child Behavior Checklist (CBCL)
Time frame: Measured at screening
Social Skills Rating Scale (SSRS)- Teacher Version
Time frame: up to 14 weeks
Permanent Mathematics Product Test (PERMP)
Time frame: up to 14 weeks
Actigraphy
Time frame: Measured daily throughout the study
Sleep Logs
Time frame: Measured daily throughout the study
Hyperactivity, Attention, and Learning Problems (HALP) Medical and Developmental History Questionnaire
Time frame: Measured at screening
HALP Rebound Effects Questionnaire
Time frame: up to 14 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24942409Bedard AC, Stein MA, Halperin JM, Krone B, Rajwan E, Newcorn JH. Differential impact of methylphenidate and atomoxetine on sustained attention in youth with attention-deficit/hyperactivity disorder. J Child Psychol Psychiatry. 2015 Jan;56(1):40-8. doi: 10.1111/jcpp.12272. Epub 2014 Jun 19.
- Derived from this study: PubMed 28647012Schulz KP, Bedard AV, Fan J, Hildebrandt TB, Stein MA, Ivanov I, Halperin JM, Newcorn JH. Striatal Activation Predicts Differential Therapeutic Responses to Methylphenidate and Atomoxetine. J Am Acad Child Adolesc Psychiatry. 2017 Jul;56(7):602-609.e2. doi: 10.1016/j.jaac.2017.04.005. Epub 2017 May 10.
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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.
Jeffrey H. Newcorn, MD principal investigator
Icahn School of Medicine at Mount Sinai
Mark A. Stein, PhD principal investigator
University of Illinois, Chicago - Institute for Juvenile Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atomoxetine and Methylphenidate in people with Attention Deficit Disorder With Hyperactivity, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.
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 11 inclusion and 11 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 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Jun 2018). 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?
ADHD-RS Total Score (time frame: up to 14 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 NCT00183391, which also lists 2 linked publications.
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 Jun 2018.