Adult Normative Performance of the Quotient ADHD System (Adult Database)
| Tracking Information | |
|---|---|
| First Received Date ICMJE | March 2, 2011 |
| Last Updated Date | April 17, 2012 |
| Start Date ICMJE | March 2011 |
| Primary Completion Date | June 2011 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
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. |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT01308450 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | Not Provided |
| Original Secondary Outcome Measures ICMJE | Not Provided |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Adult Normative Performance of the Quotient ADHD System |
| Official Title ICMJE | Adult Normative Performance on Quotient ADHD System - Adolescent and Adult Version (Ages 15-55 Years Old) |
| 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. 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 Type ICMJE | Interventional |
| Study Phase | Phase 4 |
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
| Condition ICMJE | To Increase the Number of Adolescents and Adults in the Quotient® ADHD System Database. |
| Intervention ICMJE | Device: Quotient ADHD System
The Quotient® was designed to emphasize and accurately measure an individual's capacity to attend to a demanding but monotonous attention task, while inhibiting activity and impulsive responses. This paradigm measures the individual's capacity at a given point in time, under specific and reproducible test conditions. In this way capabilities can be accurately compared to the capabilities of others at the same developmental level. Upon completion of the test, a report can be generated with the performance compared to the normal range of results for peers of the same age and gender. The Quotient® ADHD System Test has been FDA approved for the following intended use: "The system provides clinicians with objective measurements of hyperactivity, impulsivity and inattention to aid in the clinical assessment of ADHD." It can also be used to assess the effectiveness of medication and dose titration. |
| Study Arm (s) | Not Provided |
| Publications * | Not Provided |
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 300 |
| Completion Date | June 2011 |
| Primary Completion Date | June 2011 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria: Subjects are eligible for enrollment if they fulfill the following inclusion criteria:
Exclusion Criteria:
|
| Gender | Both |
| Ages | 15 Years to 55 Years |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT Number ICMJE | NCT01308450 |
| Other Study ID Numbers ICMJE | BBD0111, BBD0111 |
| Has Data Monitoring Committee | No |
| Responsible Party | BioBehavioral Diagnostics Company |
| Study Sponsor ICMJE | BioBehavioral Diagnostics Company |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | BioBehavioral Diagnostics Company |
| Verification Date | April 2012 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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