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 ]

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2. Primary:

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

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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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