A Phase 4 interventional study of Strattera (atomoxetine) in ADHD NOS, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2019-08-21.
Sponsored by Massachusetts General Hospital · Phase 4, Interventional, and Treatment
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.
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:
Primary outcomes measure symptom reduction.
1,514 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 255 are open to participants now.
This study's enrollment of 45 is below the median of 72 across 1,207 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.
Browse Attention Deficit Disorder with Hyperactivity studies →Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
Exclusion Criteria:
Clinically significant abnormal baseline laboratory values which include the following:
Only English-speaking subjects will be allowed into the study for the following reasons:
Drug: Strattera (atomoxetine)
Up to maximum of 1.2mg atomoxetine/kg PO QD, or 120 mg atomoxetine PO QD (whichever is less).
Also known as: Strattera
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.
Time frame: 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.
Time frame: baseline and 6 Weeks
Subjects were from referrals to the Adult ADHD Program at the MGH and through advertisements in the local media. The majority of subjects referred to our program first participate in our general screening protocol entitled, "A Screening Protocol for Adults with Attention Deficit Hyperactivity Disorder" (Protocol # 2002-P-001856).
| Milestone | Strattera (Atomoxetine) |
|---|---|
| Started | 45 |
| Completed | 33 |
| Not completed | 12 |
| Withdrew: Lost to follow-up | 6 |
| Withdrew: Adverse event | 4 |
| Withdrew: Non-compliance | 2 |
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.
| subjects | Strattera (Atomoxetine) |
|---|---|
| ADHD-Clinical Global Impression | 29 |
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.
| scores on a scale | Strattera (Atomoxetine) |
|---|---|
| The Adult AISRS | -12.1 ± 8.4 |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Strattera (Atomoxetine) | — | 0/45 (0%) | 45/45 (100%) |
| Event | Strattera (Atomoxetine) |
|---|---|
| Dry MouthGastrointestinal disorders | 26/45 |
| GastrointestinalGastrointestinal disorders | 22/45 |
| InsomniaGeneral disorders | 22/45 |
| Tired/fatiguedGeneral disorders | 22/45 |
| HeadacheGeneral disorders | 17/45 |
| Decreased appetiteMetabolism and nutrition disorders | 15/45 |
| Warmth/flushing/sweatingNervous system disorders | 13/45 |
| Colds/allergies/infectionsImmune system disorders | 11/45 |
| Lightheaded/dizzyGeneral disorders | 10/45 |
| Musculoskeletal discomfortMusculoskeletal and connective tissue disorders | 9/45 |
| Age, Categorical(Participants) | Strattera (Atomoxetine) |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 45 |
| >=65 years | 0 |
| Age, Continuous(years) | Strattera (Atomoxetine) |
|---|---|
| Mean | 39.5 ± 9.6 |
| Sex: Female, Male(Participants) | Strattera (Atomoxetine) |
|---|---|
| Female | 19 |
| Male | 26 |
| Region of Enrollment(participants) | Strattera (Atomoxetine) |
|---|---|
| United States | 45 |
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Attention Deficit Disorder with Hyperactivity→
Massachusetts General Hospital