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

This study has been completed.

Sponsor:

Collaborator:

Eli Lilly and Company

Information provided by:

Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT00181766

First received: September 13, 2005

Last updated: May 27, 2010

Last verified: May 2010

History of Changes

Results First Received: February 26, 2010

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	ADHD NOS
Intervention:	Drug: Strattera (atomoxetine)

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were from referrals to the Adult ADHD Program at the MGH and through advertisements in the local media. The majority of subjects referred to our program first participate in our general screening protocol entitled, “A Screening Protocol for Adults with Attention Deficit Hyperactivity Disorder” (Protocol # 2002-P-001856).

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Strattera (Atomoxetine)	Atomoxetine monotherapy up o 1.2 mg/kg/day or 120 mg/day.

Participant Flow: Overall Study

	Strattera (Atomoxetine)
STARTED	45 ^[1]
COMPLETED	33 ^[2]
NOT COMPLETED	12
Lost to Follow-up	6
Adverse Event	4
non-compliance	2

[1]	Number of subjects enrolled and treated with Atomoxetine.
[2]	Completed the trial.

Baseline Characteristics

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Reporting Groups

	Description
Strattera (Atomoxetine)	Atomoxetine monotherapy up o 1.2 mg/kg/day or 120 mg/day.

Baseline Measures

	Strattera (Atomoxetine)
Number of Participants [units: participants]	45
Age [units: participants]
<=18 years	0
Between 18 and 65 years	45
>=65 years	0
Age [units: years] Mean ± Standard Deviation	39.5 ± 9.6
Gender [units: participants]
Female	19
Male	26
Region of Enrollment [units: participants]
United States	45

Outcome Measures

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1. Primary:

ADHD-Clinical Global Impression [ Time Frame: 6 Weeks ]

Measure Type	Primary
Measure Title	ADHD-Clinical Global Impression
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All analyses were intention to treat (ITT) with the last observation carried forward (LOCF) for subjects who did not complete the full study schedule.

Reporting Groups

	Description
Strattera (Atomoxetine)	Atomoxetine monotherapy up o 1.2 mg/kg/day or 120 mg/day.

Measured Values

	Strattera (Atomoxetine)
Number of Participants Analyzed [units: participants]	45
ADHD-Clinical Global Impression [units: subjects]	29

No statistical analysis provided for ADHD-Clinical Global Impression

2. Primary:

The Adult AISRS [ Time Frame: baseline and 6 Weeks ]

Measure Type	Primary
Measure Title	The Adult AISRS
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All analyses were intention to treat (ITT) with the last observation carried forward (LOCF) for subjects who did not complete the full study schedule. Baseline and endpoint AISRS scores were compared used paired t-tests. Statistical significance was determined at alpha level 0.05.

Reporting Groups

	Description
Strattera (Atomoxetine)	Atomoxetine monotherapy up o 1.2 mg/kg/day or 120 mg/day.

Measured Values

	Strattera (Atomoxetine)
Number of Participants Analyzed [units: participants]	45
The Adult AISRS [units: scores on a scale] Mean ± Standard Deviation	-12.1 ± 8.4

No statistical analysis provided for The Adult AISRS

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
small, open label study short exposure to medication

Results Point of Contact:

Name/Title: Janet Wozniak, MD
Organization: Massachusetts General Hospital
phone: 617-503-1038
e-mail: jwozniak@partners.org

No publications provided

Responsible Party:	Janet Wozniak, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00181766 History of Changes
Other Study ID Numbers:	2003-P-002052
Study First Received:	September 13, 2005
Results First Received:	February 26, 2010
Last Updated:	May 27, 2010
Health Authority:	United States: Institutional Review Board

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