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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01272726
Other study ID # ARI-1260-ADHD
Secondary ID
Status Completed
Phase N/A
First received January 6, 2011
Last updated May 31, 2012
Start date March 2009
Est. completion date January 2011

Study information

Verified date May 2012
Source Avera McKennan Hospital & University Health Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The goal of this research study is to measure what percentage of women who suspect they have symptoms of ADHD will go on to be diagnosed with ADHD using accepted practice standards. The study will also evaluate the influence education on the genetics of ADHD has on a woman in her deciding to receive behavioral health treatment for ADHD.


Description:

Attention Deficit Hyperactivity Disorder (ADHD) affects approximately 10-12% of school-aged children in the United States, making it one of the most common psychiatric disorders in children. It is characterized as inattention and hyperactivity-impulsivity, which has persisted for at least 6 months to a degree that is maladaptive and inconsistent with developmental level (DSM-IV-TR). ADHD is a non-fluctuating illness unlike many other psychiatric co-morbid conditions.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date January 2011
Est. primary completion date December 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 59 Years
Eligibility Inclusion Criteria:

- Subjects must be females, 18 through 59 years of age

- Subjects must think they have ADHD or have been previously diagnosed with ADHD but may not have received any treatment for ADHD

- Subjects must be able to participate in the informed consent process and give their written consent to participate in the study

Exclusion Criteria:

- Subjects who have been treated (at any time) for ADHD will be excluded from the study

- Potential subjects consuming greater than 21 units of alcohol (1 unit=12.0 ounces beer, 1.5 ounces hard liquor or 5.0 ounces wine) a week will be excluded from the study

- Potential subjects currently experiencing suicidal ideation or who have been hospitalized within the past six months for suicidal ideation will be excluded from the study

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms

  • Attention Deficit Disorder with Hyperactivity
  • Attention Deficit Hyperactivity Disorder
  • Hyperkinesis

Intervention

Behavioral:
Education
Education on the genetics of ADHD and treatment options for ADHD

Locations

Country Name City State
United States Avera Research Institute Sioux Falls South Dakota

Sponsors (1)

Lead Sponsor Collaborator
Avera McKennan Hospital & University Health Center

Country where clinical trial is conducted

United States, 

References & Publications (6)

Barr CL, Feng Y, Wigg K, Bloom S, Roberts W, Malone M, Schachar R, Tannock R, Kennedy JL. Identification of DNA variants in the SNAP-25 gene and linkage study of these polymorphisms and attention-deficit hyperactivity disorder. Mol Psychiatry. 2000 Jul;5(4):405-9. — View Citation

Biederman J, Faraone SV, Keenan K, Knee D, Tsuang MT. Family-genetic and psychosocial risk factors in DSM-III attention deficit disorder. J Am Acad Child Adolesc Psychiatry. 1990 Jul;29(4):526-33. — View Citation

Biederman J, Milberger S, Faraone SV, Kiely K, Guite J, Mick E, Ablon S, Warburton R, Reed E. Family-environment risk factors for attention-deficit hyperactivity disorder. A test of Rutter's indicators of adversity. Arch Gen Psychiatry. 1995 Jun;52(6):464-70. — View Citation

Faraone SV, Doyle AE. The nature and heritability of attention-deficit/hyperactivity disorder. Child Adolesc Psychiatr Clin N Am. 2001 Apr;10(2):299-316, viii-ix. Review. — View Citation

Murphy KR, Adler LA. Assessing attention-deficit/hyperactivity disorder in adults: focus on rating scales. J Clin Psychiatry. 2004;65 Suppl 3:12-7. Review. — View Citation

Smalley SL, McGough JJ, Del'Homme M, NewDelman J, Gordon E, Kim T, Liu A, McCracken JT. Familial clustering of symptoms and disruptive behaviors in multiplex families with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2000 Sep;39(9):1135-43. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary To determine if offering relative risk genotyping for ADHD, and educating around the genetic and environmental contributions to ADHD, may lead to greater health care acceptance in women who struggle with ADHD. 24 hours No
Secondary To determine if women who think they have ADHD actually have ADHD. 24 hours No
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