Status:
COMPLETED
Strattera Treatment in Adults With Attention Deficit Hyperactivity Disorder Not Otherwise Specified (ADHD NOS)
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
ADHD NOS
Eligibility:
All Genders
18-55 years
Phase:
PHASE4
Brief 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 ...
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 wi...
Eligibility Criteria
Inclusion
- 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.
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00181766
Start Date
December 1 2003
End Date
July 1 2008
Last Update
August 21 2019
Active Locations (1)
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1
Massachusetts General Hospital
Cambridge, Massachusetts, United States, 02138