NCT00181948

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2004

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

June 22, 2010

Status Verified

June 1, 2010

Enrollment Period

3 years

First QC Date

September 13, 2005

Last Update Submit

June 18, 2010

Conditions

ADHD

Keywords

ADHDchildrenstimulant non-respondersStrattera

Outcome Measures

Primary Outcomes (2)

  • Symptom reduction using Clinical Global Impression (ADHD)

    administered weekly

  • ADHD Symptom Checklist

    administered weekly

Interventions

atomoxetine (Strattera)DRUG

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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:
  • 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.

You may not qualify if:

  • 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.
  • Mental retardation (intelligence quotient \[I.Q.\] \< 75).
  • Organic brain disorders.
  • Seizures.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Cambridge, Massachusetts, 02138, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Study Officials

  • Joseph Biederman, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

September 1, 2004

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

June 22, 2010

Record last verified: 2010-06

Locations

US(1)