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

Primary Purpose

ADHD NOS

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Strattera (atomoxetine)
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ADHD NOS focused on measuring ADHD NOS, Adults, Strattera (atomoxetine), Open-Label

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Criteria: 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.

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Strattera (atomoxetine)

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 13, 2005
Last Updated
August 12, 2019
Sponsor
Massachusetts General Hospital
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00181766
Brief Title
Strattera Treatment in Adults With Attention Deficit Hyperactivity Disorder Not Otherwise Specified (ADHD NOS)
Official Title
A Pilot Study of Strattera Treatment in Adults With Attention Deficit Hyperactivity Disorder Not Otherwise Specified
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.
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: use of a six-week design to document the response rate, weekly assessments to document the impact of Strattera NOS on functional capacities, careful assessment of safety and tolerability. Primary outcomes measure symptom reduction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD NOS
Keywords
ADHD NOS, Adults, Strattera (atomoxetine), Open-Label

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Strattera (atomoxetine)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Strattera (atomoxetine)
Other Intervention Name(s)
Strattera
Intervention Description
Up to maximum of 1.2mg atomoxetine/kg PO QD, or 120 mg atomoxetine PO QD (whichever is less).
Primary Outcome Measure Information:
Title
ADHD-Clinical Global Impression
Description
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
Title
The Adult AISRS
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janet Wozniak, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02138
Country
United States

12. IPD Sharing Statement

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

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