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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

March 2, 2011
November 4, 2013
March 2011
June 2011   (final data collection date for primary outcome measure)
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.
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 ]
The data of the study will be used to identify normative ranges and percentiles by age and gender. Each group of 25 will be compared for group differences between genders, and evaluated for the effects of age on performance. The SPSS software (SPSS Inc., Chicago, Illinois) will be used for statistic procedures in this study.
Complete list of historical versions of study NCT01308450 on ClinicalTrials.gov Archive Site
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Adult Normative Performance of the Quotient ADHD System
Adult Normative Performance on Quotient ADHD System - Adolescent and Adult Version (Ages 15-55 Years Old)

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).

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

Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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Non-Probability Sample

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

ADHD
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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.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
June 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
15 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01308450
BBD0111, BBD0111
No
BioBehavioral Diagnostics Company
BioBehavioral Diagnostics Company
Not Provided
Not Provided
BioBehavioral Diagnostics Company
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP