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CompletedNCT00181766Updated Aug 21, 2019Results posted

Strattera Treatment in Adults With Attention Deficit Hyperactivity Disorder Not Otherwise Specified (ADHD NOS)

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

Phase
Phase 4
Study type
Interventional
Enrollment
45
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
All
01

Study 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. 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:

  1. use of a six-week design to document the response rate,
  2. weekly assessments to document the impact of Strattera NOS on functional capacities,
  3. careful assessment of safety and tolerability.

Primary outcomes measure symptom reduction.

02

Conditions studied

  • ADHD NOS

Keywords

  • ADHD NOS
  • Adults
  • Strattera (atomoxetine)
  • Open-Label
03

In context

Attention Deficit Disorder with Hyperactivity

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Male and female outpatients older than 18 and younger than 55 years of age.
  2. 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:

    1. having currently at least 6/9 current items of either inattention or hyperactivity/impulsivity but \< 5 items from either list in childhood; or
    2. 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.
  3. Subjects will have a current Clinical Global Impression ADHD score of 4 or higher.
  4. 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.
  5. 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.
  6. 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.
  7. 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.
  8. Subjects with mild cases of asthma and allergy will be allowed to participate.
  9. Subjects with acid reflux syndrome will be allowed to participate.
  10. Subjects with hypercholesterolemia who are on a stable dose of cholesterol-lowering medication will be allowed to participate.

Exclusion criteria

Exclusion Criteria:

  1. 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.
  2. Any metabolic, neurological, hepatic, renal, cardiovascular, hematological, ophthalmic, or endocrine disease.
  3. Clinically significant abnormal baseline laboratory values which include the following:

    1. Values larger than 20% above the upper range of the laboratory standard of a basic metabolic screen.
    2. Exclusionary blood pressure parameters will include any values above 140 (systolic) and 90 (diastolic).
    3. 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.
  4. Mental retardation (intelligence quotient [I.Q.] \< 75).
  5. Organic brain disorders.
  6. Pregnant or nursing females.
  7. Subjects with current adequate treatment for ADHD or a history of a previous adequate trial of Strattera.
  8. Subjects who have failed to respond to an adequate trial, or who have had tolerability problems on Strattera.
  9. Only English-speaking subjects will be allowed into the study for the following reasons:

    1. the assessment instruments are not available and have not been adequately standardized in other languages;
    2. the researchers' clinical trials facility is located in Cambridge and not in the Massachusetts General Hospital (MGH) main campus without the availability of translators;
    3. psychiatric questionnaires and evaluations are taxing and adding the complexity of a translator has the potential to make the patient experience even more exhausting.
  10. Prior hypersensitivity to Strattera.
  11. MAOI antidepressant use currently or within two weeks of starting study.
  12. Urinary retention or bladder dysfunction.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
45 participants (actual)

Study arms

  • Experimental
    Strattera (atomoxetine)

    Drug: Strattera (atomoxetine)

Interventions

  • DrugStrattera (atomoxetine)

    Up to maximum of 1.2mg atomoxetine/kg PO QD, or 120 mg atomoxetine PO QD (whichever is less).

    Also known as: Strattera

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

07

Results

Posted Jun 23, 2010
Limitations and caveats
* small, open label study * short exposure to medication

Participant flow

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).

Participant flow — Overall Study
MilestoneStrattera (Atomoxetine)
Started45
Completed33
Not completed12
Withdrew: Lost to follow-up6
Withdrew: Adverse event4
Withdrew: Non-compliance2

Outcome measures

PrimaryADHD-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
Reported as:
Number · subjects
ADHD-Clinical Global Impression
subjectsStrattera (Atomoxetine)
ADHD-Clinical Global Impression29
PrimaryThe 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
Reported as:
Mean · scores on a scale
The Adult AISRS
scores on a scaleStrattera (Atomoxetine)
The Adult AISRS-12.1 ± 8.4

Adverse events

Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Strattera (Atomoxetine)—0/45 (0%)45/45 (100%)
Most frequent other events
Showing 10 of 31
Most frequent other events
EventStrattera (Atomoxetine)
Dry MouthGastrointestinal disorders26/45
GastrointestinalGastrointestinal disorders22/45
InsomniaGeneral disorders22/45
Tired/fatiguedGeneral disorders22/45
HeadacheGeneral disorders17/45
Decreased appetiteMetabolism and nutrition disorders15/45
Warmth/flushing/sweatingNervous system disorders13/45
Colds/allergies/infectionsImmune system disorders11/45
Lightheaded/dizzyGeneral disorders10/45
Musculoskeletal discomfortMusculoskeletal and connective tissue disorders9/45

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Strattera (Atomoxetine)
<=18 years0
Between 18 and 65 years45
>=65 years0
Age, Continuous
Age, Continuous(years)Strattera (Atomoxetine)
Mean39.5 ± 9.6
Sex: Female, Male
Sex: Female, Male(Participants)Strattera (Atomoxetine)
Female19
Male26
Region of Enrollment
Region of Enrollment(participants)Strattera (Atomoxetine)
United States45
08

Study locations

1 site
  • Massachusetts General Hospital
    Cambridge, Massachusetts 02138, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00181766
Lead sponsor
Massachusetts General Hospital
Collaborators
Eli Lilly and Company
Responsible party
Joseph Biederman, MD (Chief, Clinical and Research Program in Pediatric Psychopharmacology and Adult ADHD; Professor of Psychiatry, Harvard Medical School, Massachusetts General Hospital) — Principal investigator
First posted
Sep 16, 2005
Start date
Dec 2003
Primary completion
Jul 2008
Completion
Jul 2008
Results posted
Jun 23, 2010
Last update
Aug 21, 2019

Study contacts

Janet Wozniak, MD
principal investigator · Massachusetts General Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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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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