ADHD NOSPhase 4NCT00181766
Strattera Treatment in Adults With Attention Deficit Hyperactivity Disorder Not Otherwise Specified (ADHD NOS)
A Phase 4 study testing Strattera (atomoxetine) in people with ADHD NOS, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This is an open-label study with daily doses up to 144 mg/day Strattera (atomoxetine) in the treatment of adults with attention deficit hyperactivity disorder not otherwise specified. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- ADHD NOS
- What is being tested?
- Strattera (atomoxetine)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2003to Jul 2008
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female outpatients older than 18 and younger than 55 years of age.
- Subjects with the diagnosis of attention deficit hyperactivity disorder not otherwise specified (ADHD NOS), by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), as manifested in clinical evaluation and confirmed by structured interview. This is operationalized by either:
- having currently at least 6/9 current items of either inattention or hyperactivity/impulsivity but < 5 items from either list in childhood; or
- having 5 out of 9 current DSM-IV items of inattention and/or hyperactivity/impulsivity, but not having 6 current symptoms in either category. This second category will be included independent of the presence or absence of ADHD symptoms in childhood.
- Subjects will have a current Clinical Global Impression ADHD score of 4 or higher.
- Subjects with past history of depression or anxiety disorder (including obsessive compulsive disorder [OCD]) without current disorder for > 3 months as ascertained through structured diagnostic interview and clinical exam will be allowed to participate.
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- Subjects treated for anxiety disorders and depression who are on a stable medication regimen for at least three months, and who have a disorder specific 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 past history of substance use disorders but have been asymptomatic for at least 6 months and have a negative drug screen will be allowed to participate.
- Subjects receiving non-monoamine oxidase inhibitor (MAOI) antidepressants (e.g., selective serotonin reuptake inhibitors [SSRIs], bupropion, venlafaxine), or benzodiazepines who have been on a stable regimen for > 3 months for any of the conditions listed above.
- Subjects with mild cases of asthma and allergy will be allowed to participate.
- Subjects with acid reflux syndrome will be allowed to participate.
- Subjects with hypercholesterolemia who are on a stable dose of cholesterol-lowering medication will be allowed to participate.
Who cannot join
- Any clinically unstable psychiatric conditions including the following: acute psychosis, acute panic, acute OCD, acute mania, acute suicidality, lifetime history of bipolar disorder, 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 larger than 20% above the upper range of the laboratory standard of a basic metabolic screen.
- 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.
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- Mental retardation (intelligence quotient [I.Q.] < 75).
- Organic brain disorders.
- Pregnant or nursing females.
- Subjects with current adequate treatment for ADHD or a history of a previous adequate trial of Strattera.
- Subjects who have failed to respond to an adequate trial, or who have had tolerability problems on Strattera.
- 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 researchers' 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.
- Prior hypersensitivity to Strattera.
- MAOI antidepressant use currently or within two weeks of starting study.
- Urinary retention or bladder dysfunction.
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 Adults With Attention Deficit Hyperactivity Disorder Not Otherwise Specified
This is an open-label study with daily doses up to 144 mg/day Strattera (atomoxetine) in the treatment of adults with attention deficit hyperactivity disorder not otherwise specified. The researchers hypothesize ADHD symptomatology in adults with ADHD NOS will be responsive to Strattera treatment and Strattera treatment (in doses of up to 120 mg/day or 1.5 mg/kg/day, whichever is less) in adults with ADHD NOS will be safe and well tolerated.
Read the detailed description
Strattera (atomoxetine) is a non-stimulant specific norepinephrine reuptake inhibitor recently approved by the Food and Drug Administration for the treatment of child, adolescent and adult patients with ADHD. It is possible Strattera could be a viable alternative treatment for ADHD individuals. The purpose of this study is to assess the effectiveness, safety and tolerability of Strattera in adults with ADHD NOS. If this initial study shows promise, we will follow-up with a randomized clinical trial.
The study includes:
- use of a six-week design to document the response rate,
- weekly assessments to document the impact of Strattera NOS on functional capacities,
- careful assessment of safety and tolerability.
Primary outcomes measure symptom reduction.
- Conditions
- ADHD NOS
- Being tested
- Strattera (atomoxetine)
- Keywords
- ADHD NOS, Adults, Strattera (atomoxetine), Open-Label
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strattera (atomoxetine)Drug
Also called Strattera
Up to maximum of 1.2mg atomoxetine/kg PO QD, or 120 mg atomoxetine PO QD (whichever is less).
| Study group | Role | What they receive |
|---|---|---|
| Strattera (atomoxetine) | Experimental | Not described Receives: Drug: Strattera (atomoxetine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADHD-Clinical Global Impression
The CGI includes Global Severity (1=not ill; 7=extremely ill) and the Global Improvement (1=very much improved; 7=very much worse) Scales. Overall severity and change in severity of ADHD was assessed with the Clinical Global Impression Scale (CGI). Improvement was defined by CGI-I ≤2, much or very much improved, at study endpoint. Results are given as number of subjects who improved according to the CGI-I using the definition above.
Measured: 6 Weeks
The Adult AISRS
The Adult AISRS was used to assess each of the 18 individual criteria symptoms (both inattentive and hyperactive) of ADHD in DSMIV on a severity grid (0=not present; 3=severe; minimum score=0; maximum score=54). Results are given as average change (reduction) in AISRS symptoms from baseline to Week 6.
Measured: baseline and 6 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 startDec 2003
- Primary completionJul 2008
- Study completionJul 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 ADHD NOSStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Principal investigator, Joseph Biederman, MD, Massachusetts General Hospital
- Investigators
- Janet Wozniak, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00181766
- Sponsor's protocol ID
- 2003-P-002052
- Status last verified
- Aug 2019
- First submitted
- 13 Sep 2005
- Last updated
- 21 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Strattera Treatment in Adults With Attention Deficit Hyperactivity Disorder Not Otherwise Specified
- ClinicalTrials.gov ID
- NCT00181766
- Acronym / sponsor ID
- 2003-P-002052
- Conditions
- ADHD NOS
- Keywords
- ADHD NOS, Adults, Strattera (atomoxetine), Open-Label
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- Dec 2003
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Posted 23 Jun 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label study with daily doses up to 144 mg/day Strattera (atomoxetine) in the treatment of adults with attention deficit hyperactivity disorder not otherwise specified. The researchers hypothesize ADHD symptomatology in adults with ADHD NOS will be responsive to Strattera treatment and Strattera treatment (in doses of up to 120 mg/day or 1.5 mg/kg/day, whichever is less) in adults with ADHD NOS will be safe and well tolerated.
Detailed description
Strattera (atomoxetine) is a non-stimulant specific norepinephrine reuptake inhibitor recently approved by the Food and Drug Administration for the treatment of child, adolescent and adult patients with ADHD. It is possible Strattera could be a viable alternative treatment for ADHD individuals. The purpose of this study is to assess the effectiveness, safety and tolerability of Strattera in adults with ADHD NOS. If this initial study shows promise, we will follow-up with a randomized clinical trial.
The study includes:
- use of a six-week design to document the response rate,
- weekly assessments to document the impact of Strattera NOS on functional capacities,
- careful assessment of safety and tolerability.
Primary outcomes measure symptom reduction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Strattera (atomoxetine) | Experimental | Drug: Strattera (atomoxetine) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Male and female outpatients older than 18 and younger than 55 years of age.
- Subjects with the diagnosis of attention deficit hyperactivity disorder not otherwise specified (ADHD NOS), by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), as manifested in clinical evaluation and confirmed by structured interview. This is operationalized by either:
- Subjects will have a current Clinical Global Impression ADHD score of 4 or higher.
- Subjects with past history of depression or anxiety disorder (including obsessive compulsive disorder [OCD]) without current disorder for > 3 months as ascertained through structured diagnostic interview and clinical exam will be allowed to participate.
- Subjects treated for anxiety disorders and depression who are on a stable medication regimen for at least three months, and who have a disorder specific 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 (18 listed)
- Any clinically unstable psychiatric conditions including the following: acute psychosis, acute panic, acute OCD, acute mania, acute suicidality, lifetime history of bipolar disorder, 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:
- 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 |
|---|---|---|
| Strattera (atomoxetine)Also: StratteraUp to maximum of 1.2mg atomoxetine/kg PO QD, or 120 mg atomoxetine PO QD (whichever is less). | Drug | Strattera (atomoxetine) |
Primary outcome
ADHD-Clinical Global Impression
Time frame: 6 Weeks
The CGI includes Global Severity (1=not ill; 7=extremely ill) and the Global Improvement (1=very much improved; 7=very much worse) Scales. Overall severity and change in severity of ADHD was assessed with the Clinical Global Impression Scale (CGI). Improvement was defined by CGI-I ≤2, much or very much improved, at study endpoint. Results are given as number of subjects who improved according to the CGI-I using the definition above.
The Adult AISRS
Time frame: baseline and 6 Weeks
The Adult AISRS was used to assess each of the 18 individual criteria symptoms (both inattentive and hyperactive) of ADHD in DSMIV on a severity grid (0=not present; 3=severe; minimum score=0; maximum score=54). Results are given as average change (reduction) in AISRS symptoms from baseline to Week 6.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Janet Wozniak, 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 Strattera (atomoxetine) in people with ADHD NOS, 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 12 inclusion and 18 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 21 Aug 2019. 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?
Yes. Results are posted in the registry (first posted 23 Jun 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?
ADHD-Clinical Global Impression (time frame: 6 Weeks). 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 21 Aug 2019.