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| ID | Type | Description | Link |
|---|---|---|---|
| BBD0111 | Other Identifier | BioBehavioral Diagnostics Company |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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:
| 12 to 18 weeks |
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Inclusion Criteria:
Subjects are eligible for enrollment if they fulfill the following inclusion criteria:
Exclusion Criteria:
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Well-screened, Healthy Non-ADHD Controls, Ages 15-55 from a single private practice clinic.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Focus Center | Clinton | Utah | 84015 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29116540 | Derived | Pivonello R, Muscogiuri G, Holder G, Paul M, Sarp S, Lesogor A, Jordaan P, Eisinger J, Colao A. Long-term safety of long-acting octreotide in patients with diabetic retinopathy: results of pooled data from 2 randomized, double-blind, placebo-controlled phase 3 studies. Endocrine. 2018 Apr;60(1):65-72. doi: 10.1007/s12020-017-1448-5. Epub 2017 Nov 7. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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:
| Posted | Number | participants | 12 to 18 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Calvin R. Sumner, MD, CMO, Sr. VP for Clinical Development | BioBDx | 978-431-5103 | calvin_sumner@biobdx.com |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 |
| 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. |
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| 0 |
| 300 |
| 0 |
| 300 |
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