Adult Normative Performance of the Quotient ADHD System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BioBehavioral Diagnostics Company
ClinicalTrials.gov Identifier:
NCT01308450
First received: March 2, 2011
Last updated: November 4, 2013
Last verified: November 2013
  Purpose

This study is being conducted to enhance and extend the clinical utility of the Quotient® ADHD System Adolescent and Adult Version Test by adding large numbers of well-screened controls to the existing Quotient® ADHD System database of adolescents and adults (ages 15-55).


Condition Phase
ADHD
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Adult Normative Performance on Quotient ADHD System - Adolescent and Adult Version (Ages 15-55 Years Old)

Further study details as provided by BioBehavioral Diagnostics Company:

Primary Outcome Measures:
  • Well-screened, Non-ADHD Controls to Augment the Existing Adolescent and Adult Database Thus Expanding the Normative Reference Range of Performance of the Quotient® Adolescent and Adult Version Test. [ Time Frame: 12 to 18 weeks ] [ Designated as safety issue: No ]

    To increase the number of "normal" Adolescent and Adult tests to the existing Quotient System Database. To assure subjects are "normal", participants will complete a standard battery of self assessment questionnaires to screen for the presence of mental health issues including: ADHD, Anxiety Disorder, Depressive Disorder or Bipolar Disorder using the following well established scales and their scoring guidelines:

    1. ADHD Self Rating Scale (ASRS)
    2. Zung Self-Rated Anxiety Scale (SAS)
    3. Zung Self-Rated Depression Scale (SDS)
    4. Mood Disorder Questionnaire (MDQ)
    5. Quotient® ADHD System Test, Adolescent and version Each subject and their individual assessment scores will be evaluated by a physician. Those participants evaluated as "normal"(without ADHD) will have the results of their Quotient test added to the existing Quotient normative database of Non ADHD subjects.


Enrollment: 300
Study Start Date: March 2011
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Single Arm, Non ADHD Control Group
Single site, single visit study. Subjects will be administered Standard Rating Scales (Defined) and the Quotient ADHD System Test (Adolescent and Adult Version). Subject's assessed to be Non-ADHD will be eligible to have their Quotient tests added to the Quotient Adolescent and Adult Normative Database.

Detailed Description:

This study consists of one study visit. Subjects will be recruited using the clinic's relevant patient population. A "Study Recruitment Flyer" will also be posted in various clinic locations (Attachment BBD0111-1). Interested volunteers will participate in an initial screening, which may be done by telephone or in person that will be conducted by the clinic's research staff. Upon preliminary confirmation that the subject meets all inclusion criteria and does not meet any exclusion criteria, an appointment will be scheduled for the study visit.

At the study visit, study will be explained in detail. Adults will be asked to provide written informed consent, parents/guardians of individuals <18 year old will provide written informed consent and minor individual's will provide written assent, prior to any study procedure being performed.

Following consent, a medical history, including current medications the subject is taking, will be obtained. Subjects will complete standard self assessment questionnaires to screen for presence of mental health issues including ADHD, anxiety disorder, depressive disorder or bipolar disorder using the ADHD Self Rating Scale (ASRS), Zung Self-Rated Anxiety Scale (SAS), Zung Self-Rated Depression Scale (SDS), and Mood Disorder Questionnaire (MDQ).

Subjects will not be excluded from the study based on responses to the mental health questionnaires, but results will be considered in the analysis of results.

The subjects will take the 20-minute Quotient® ADHD System Test for Adolescent and Adult assessment.

Subject's assessed to be Non-ADHD will be eligible to have their Quotient tests added to the Quotient Adolescent and Adult Normative Database.

Study Enrollment:

200 Normal control subjects with oversampling of 10%. Total enrollment is expected to be 220.

Study Population:

Male and female subjects from age 15 through 55 years of age. Optimally, there will be approximately 25 subjects per age and gender category but enrollment will not be restricted or limited to these desired categorical goals.

Age Ranges Males Females 15-25 25 25 26-35 25 25 36-45 25 25 46-55 25 25

  Eligibility

Ages Eligible for Study:   15 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Well-screened, Healthy Non-ADHD Controls, Ages 15-55 from a single private practice clinic.

Criteria

Inclusion Criteria:

Subjects are eligible for enrollment if they fulfill the following inclusion criteria:

  1. Male or Female
  2. Ages 15 to 55
  3. Un-medicated with medications known to affect ADHD or cognitive functioning
  4. Report of good physical health
  5. Able to understand test instructions and comply with testing
  6. Willing to give written informed consent and/or assent

Exclusion Criteria:

  1. History of diagnosis of ADHD
  2. History of known neurological disease or insult (e.g., head trauma with LOC, skull fracture, past or present migraine headaches, seizure disorders)
  3. Major Medical Disorders
  4. Past/present alcohol or substance abuse or dependence
  5. Current or past DSM-IV disorder, screened by the computerized SCID I & II, and reviewed by investigator
  6. Any major medical or neurological condition that could affect motor activity or attention (e.g. Parkinson's, MS, dementia)
  7. Currently ill with cold/flu/infections which may compromise their ability to perform the computer task
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01308450

Locations
United States, Utah
The Focus Center
Clinton, Utah, United States, 84015
Sponsors and Collaborators
BioBehavioral Diagnostics Company
  More Information

No publications provided

Responsible Party: BioBehavioral Diagnostics Company
ClinicalTrials.gov Identifier: NCT01308450     History of Changes
Other Study ID Numbers: BBD0111, BBD0111
Study First Received: March 2, 2011
Results First Received: February 4, 2013
Last Updated: November 4, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by BioBehavioral Diagnostics Company:
ADHD Normative Control Group

ClinicalTrials.gov processed this record on October 19, 2014