Adult Normative Performance of the Quotient ADHD System

BioBehavioral Diagnostics Company

Status: Completed

Conditions: ADHD

Study type: Observational

Funder types: Industry

Identifiers

NCT01308450

BBD0111 (Other Identifier)

Details and patient eligibility

About

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).

Full 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

Enrollment: 300 patients

Sex: All

Ages: 15 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

300 participants in 1 patient group

Single Arm, Non ADHD Control Group

Description:

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.