Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:02 PM
Ignite Modification Date:
2025-12-24 @ 5:02 PM
NCT ID:
NCT01308450
Brief Summary:
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).
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
Study:
NCT01308450
Study Brief:
Protocol Section:
NCT01308450