Strattera Treatment in Children With ADHD Who Have Poor Response to Stimulant Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00181948
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : June 22, 2010
Eli Lilly and Company
Information provided by:
Massachusetts General Hospital

Brief 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. 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.

Condition or disease Intervention/treatment Phase
ADHD Drug: atomoxetine (Strattera) Phase 4

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Strattera Treatment in Children With Attention-Deficit/Hyperactivity Disorder Who Have Poor Response to Stimulant Therapy
Study Start Date : September 2004
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Symptom reduction using Clinical Global Impression (ADHD) [ Time Frame: administered weekly ]
  2. ADHD Symptom Checklist [ Time Frame: administered weekly ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.
  • 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:

    1. the assessment instruments are not available and have not been adequately standardized in other languages;
    2. the 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.

Exclusion Criteria:

  • Any clinically unstable psychiatric conditions including the following:

    • acute psychosis,
    • acute panic,
    • acute OCD,
    • acute mania,
    • acute suicidality,
    • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00181948

United States, Massachusetts
Massachusetts General Hospital
Cambridge, Massachusetts, United States, 02138
Sponsors and Collaborators
Massachusetts General Hospital
Eli Lilly and Company
Principal Investigator: Joseph Biederman, MD Massachusetts General Hospital

Responsible Party: Joseph Biederman, MD, Massachusetts General Hospital Identifier: NCT00181948     History of Changes
Other Study ID Numbers: 2004-P-000883
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: June 22, 2010
Last Verified: June 2010

Keywords provided by Massachusetts General Hospital:
stimulant non-responders

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Atomoxetine Hydrochloride
Central Nervous System Stimulants
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs