Trial Outcomes & Findings for Adult Normative Performance of the Quotient ADHD System (NCT NCT01308450)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

300 participants

Primary outcome timeframe

12 to 18 weeks

Results posted on

2013-11-27

Participant Flow

302 subjects meeting enrollment criteria were recruited for this study from a database of patients from a single site, The Focus Center. 300 subjects were eligible to participated and signed Informed Consent.

This one visit, one site study was conducted to enhance and extend the current "normative" database of the adolescent and adult version of the Quotient ADHD System, an FDA cleared medical device. The study enrolled both male and females, between the ages of 15 and 55 (to match the current database)who were considered "normal", non-ADHD subjects.

Participant milestones

Participant milestones
Measure	Adolescent and Adult Normative Group Males and Females from ages 15 -55 divided into 4 age groups: 15-25; 26-35;36-45 and 46-55 with each group having approximately equal representation of both genders. Subjects will be recruited to represent a "normative" adolescent and adult sampling of subjects who are not known to have ADHD.
Overall Study STARTED	302
Overall Study COMPLETED	300
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Adult Normative Performance of the Quotient ADHD System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adolescent and Adult Normative Group n=302 Participants Males and Females from ages 15 -55 divided into 4 age groups: 15-25; 26-35;36-45 and 46-55 with each group having approximately equal representation of both genders. Subjects will be recruited to represent a "normative" adolescent and adult sampling of subjects who are not known to have ADHD.
Age, Categorical <=18 years	22 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	280 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	155 Participants n=5 Participants
Sex: Female, Male Male	147 Participants n=5 Participants
Region of Enrollment United States	302 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 to 18 weeks

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.

Outcome measures

Outcome measures
Measure	Adolescent and Adult Normative Group n=300 Participants Males and Females from ages 15 -55 divided into 4 age groups: 15-25; 26-35;36-45 and 46-55 with each group having approximately equal representation of both genders. Subjects will be recruited to represent a "normative" adolescent and adult sampling of subjects who are not known to have ADHD.
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.	300 participants 300

Adverse Events

Adolescent and Adult Normative Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Calvin R. Sumner, MD, CMO, Sr. VP for Clinical Development

BioBDx

Phone: 978-431-5103

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place