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

NCT00181766 | Completed Phase 4 Results DMC

• 1 other identifier: 2003-P-002052
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

ADHD NOS

Keywords

ADHD NOS; Adults; Strattera (atomoxetine); Open-Label

Outcome Measures

Primary Outcomes (2)

• 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.

  6 Weeks

• 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.

  baseline and 6 Weeks

Study Arms (1)

Strattera (atomoxetine)

EXPERIMENTAL

Drug: Strattera (atomoxetine)

Interventions

Strattera (atomoxetine) DRUG

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

Also known as: Strattera

Strattera (atomoxetine)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Massachusetts General Hospital

Cambridge, Massachusetts, 02138, United States

Location

MeSH Terms

Interventions

Atomoxetine Hydrochloride

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Limitations and Caveats

* small, open label study * short exposure to medication

Results Point of Contact

• Title: Joseph Biederman, MD
• Organization: Massachusetts General Hospital

jbiederman@partners.org

617-726-1743

Study Officials

• Janet Wozniak, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Clinical and Research Program in Pediatric Psychopharmacology and Adult ADHD; Professor of Psychiatry, Harvard Medical School

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 16, 2005
• Study Start: December 1, 2003
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: August 21, 2019
• Results First Posted: June 23, 2010

Record last verified: 2019-08

Locations

US (1)