ADHDPhase 4NCT00181948
Strattera Treatment in Children With ADHD Who Have Poor Response to Stimulant Therapy
A Phase 4 study testing atomoxetine (Strattera) in people with ADHD, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This will be a 6-week, unblinded study using the medication Strattera for children and adolescents with attention deficit hyperactivity disorder (ADHD) who failed to respond to an adequate trial of stimulant treatment. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- ADHD
- What is being tested?
- atomoxetine (Strattera)
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Sep 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Male and female outpatients 6-17 years of age.
- Subjects with the diagnosis of attention deficit hyperactivity disorder (ADHD), by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), as manifested in clinical evaluation and confirmed by structured interview.
- ADHD rating scale-symptom checklist > 24
- Subjects with a past history of depression, bipolar disorder, anxiety disorder (including obsessive compulsive disorder [OCD]) without current disorder for > 3 months as ascertained through structured diagnostic interview and clinical exam.
- Subjects treated for anxiety disorders and depression (with non-MAOI antidepressants [e.g., SSRIs, bupropion, venlafaxine] or benzodiazepines) who are on a stable medication regimen for at least three months, and who have a disorder specific Clinical Global Impression (CGI)-severity score ≤ 3 (mildly ill) and who have a score on the Hamilton-Depression and Hamilton-Anxiety Rating Scale below 15 (mild range) will be included in the study.
- Subjects with a past or present history of tics will be eligible.
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- Subjects with a past history of substance use disorders but drug and alcohol free for > 6 months.
- Subjects with mild cases of asthma and allergy will be included.
- Potential subjects will have failed an adequate trial of a stimulant as defined by:
- Subjects who had intolerable side effects on a stimulant, or
- Poor response (an ADHD CGI-I of > 3) on at least 4 weeks of > 1.0 mg/kg/day of a methylphenidate product; or > 0.5 mg/kg/day of an amphetamine product.
- Only English-speaking subjects will be allowed into the study for the following reasons:
- the assessment instruments are not available and have not been adequately standardized in other languages;
- the clinical trials facility is located in Cambridge and not in the Massachusetts General Hospital (MGH) main campus without the availability of translators;
- psychiatric questionnaires and evaluations are taxing and adding the complexity of a translator has the potential to make the patient experience even more exhausting.
Who cannot join
- Any clinically unstable psychiatric conditions including the following:
- acute psychosis,
- acute panic,
- acute OCD,
- acute mania,
- acute suicidality,
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- acute substance use disorders (alcohol or drugs),
- sociopathy,
- criminality.
- Any metabolic, neurological, hepatic, renal, cardiovascular, hematological, ophthalmic, or endocrine disease.
- Clinically significant abnormal baseline laboratory values which include the following:
- Values which deviate greater than 20% from the normal ranges of the laboratory standard for a basic metabolic screen and complete blood count.
- Exclusionary blood pressure parameters will include any values above 140 (systolic) and 90 (diastolic).
- Exclusionary electrocardiogram (ECG) parameters will include a QTC > 460 msec, QRS >120 msec, and PR > 200 msec. Subjects having ECG evidence of ischemia or arrhythmia as reviewed by an independent cardiologist.
- Mental retardation (intelligence quotient [I.Q.] < 75).
- Organic brain disorders.
- Seizures.
- Pregnant or nursing females.
- Subjects with current adequate treatment for ADHD or a history of a previous adequate trial of Strattera.
- Prior hypersensitivity to atomoxetine.
- MAOI antidepressant use currently or within two weeks of starting study.
- Urinary retention or bladder dysfunction.
- Narrow angle glaucoma.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Cambridge, Massachusetts, 02138
About this study
Official title: A Pilot Study of Strattera Treatment in Children With Attention-Deficit/Hyperactivity Disorder Who Have Poor Response to Stimulant Therapy
This will be a 6-week, unblinded study using the medication Strattera for children and adolescents with attention deficit hyperactivity disorder (ADHD) who failed to respond to an adequate trial of stimulant treatment. Specific hypotheses are as follows:
Hypothesis 1: ADHD symptomatology in youth with ADHD will be responsive to Strattera treatment in the short term.
Hypothesis 2: Strattera treatment (in doses of up to 120 mg/day or 1.2 mg/kg/day) in children and adolescents with ADHD will be safe and well tolerated.
Read the detailed description
Strattera (atomoxetine) is a non-stimulant presynaptic norepinephrine reuptake inhibitor recently approved by the Food and Drug Administration for use in child, adolescent and adult patients with ADHD. Atomoxetine is a potent inhibitor of the presynaptic norepinephrine transporter with minimal affinity for other noradrenergic receptors or for other neurotransmitter transporters or receptors. Thus, Strattera could be a viable alternative treatment for ADHD individuals who do not respond to stimulants.
The purpose of this study is to assess the effectiveness, safety and tolerability of Strattera in youth, ages 6-17 years with ADHD who failed to respond to an adequate trial of stimulant treatment. If this initial study shows proof of the concept, we will follow-up the study with a randomized clinical trial.
- Conditions
- ADHD
- Being tested
- atomoxetine (Strattera)
- Keywords
- ADHD, children, stimulant non-responders, Strattera
- 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.
atomoxetine (Strattera)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom reduction using Clinical Global Impression (ADHD)
Measured: administered weekly
ADHD Symptom Checklist
Measured: administered weekly
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 startSep 2004
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Investigators
- Joseph Biederman, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00181948
- Sponsor's protocol ID
- 2004-P-000883
- Status last verified
- Jun 2010
- First submitted
- 13 Sep 2005
- Last updated
- 22 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Strattera Treatment in Children With Attention-Deficit/Hyperactivity Disorder Who Have Poor Response to Stimulant Therapy
- ClinicalTrials.gov ID
- NCT00181948
- Acronym / sponsor ID
- 2004-P-000883
- Conditions
- ADHD
- Keywords
- ADHD, children, stimulant non-responders, Strattera
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- Sep 2004
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a 6-week, unblinded study using the medication Strattera for children and adolescents with attention deficit hyperactivity disorder (ADHD) who failed to respond to an adequate trial of stimulant treatment. Specific hypotheses are as follows:
Hypothesis 1: ADHD symptomatology in youth with ADHD will be responsive to Strattera treatment in the short term.
Hypothesis 2: Strattera treatment (in doses of up to 120 mg/day or 1.2 mg/kg/day) in children and adolescents with ADHD will be safe and well tolerated.
Detailed description
Strattera (atomoxetine) is a non-stimulant presynaptic norepinephrine reuptake inhibitor recently approved by the Food and Drug Administration for use in child, adolescent and adult patients with ADHD. Atomoxetine is a potent inhibitor of the presynaptic norepinephrine transporter with minimal affinity for other noradrenergic receptors or for other neurotransmitter transporters or receptors. Thus, Strattera could be a viable alternative treatment for ADHD individuals who do not respond to stimulants.
The purpose of this study is to assess the effectiveness, safety and tolerability of Strattera in youth, ages 6-17 years with ADHD who failed to respond to an adequate trial of stimulant treatment. If this initial study shows proof of the concept, we will follow-up the study with a randomized clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (15 listed)
- Male and female outpatients 6-17 years of age.
- Subjects with the diagnosis of attention deficit hyperactivity disorder (ADHD), by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), as manifested in clinical evaluation and confirmed by structured interview.
- ADHD rating scale-symptom checklist > 24
- Subjects with a past history of depression, bipolar disorder, anxiety disorder (including obsessive compulsive disorder [OCD]) without current disorder for > 3 months as ascertained through structured diagnostic interview and clinical exam.
- Subjects treated for anxiety disorders and depression (with non-MAOI antidepressants [e.g., SSRIs, bupropion, venlafaxine] or benzodiazepines) who are on a stable medication regimen for at least three months, and who have a disorder specific Clinical Global Impression (CGI)-severity score ≤ 3 (mildly ill) and who have a score on the Hamilton-Depression and Hamilton-Anxiety Rating Scale below 15 (mild range) will be included in the study.
Key exclusion criteria (23 listed)
- Any clinically unstable psychiatric conditions including the following:
- Any metabolic, neurological, hepatic, renal, cardiovascular, hematological, ophthalmic, or endocrine disease.
- Clinically significant abnormal baseline laboratory values which include the following:
- Mental retardation (intelligence quotient [I.Q.] < 75).
- Organic brain disorders.
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 |
|---|---|---|
| atomoxetine (Strattera) | Drug | – |
Primary outcome
Symptom reduction using Clinical Global Impression (ADHD)
Time frame: administered weekly
ADHD Symptom Checklist
Time frame: administered weekly
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2010.
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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.
Joseph Biederman, MD principal investigator
Massachusetts General Hospital
1 site 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 (Strattera) in people with ADHD, run by Massachusetts General Hospital at 1 site 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 15 inclusion and 23 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 22 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Symptom reduction using Clinical Global Impression (ADHD) (time frame: administered weekly). The study lists 2 primary outcomes in all. 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 22 Jun 2010.