Adult Normative Performance of the Quotient ADHD System

NCT01308450 | Completed Results

• 1 other identifier: BBD0111
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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).

Conditions

ADHD

Keywords

ADHD Normative Control Group

Outcome Measures

Primary Outcomes (1)

• 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: 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.

  12 to 18 weeks

Study Arms (1)

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.

Eligibility Criteria

• Age: 15 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Well-screened, Healthy Non-ADHD Controls, Ages 15-55 from a single private practice clinic.

You may qualify if:

• Male or Female
• Ages 15 to 55
• Un-medicated with medications known to affect ADHD or cognitive functioning
• Report of good physical health
• Able to understand test instructions and comply with testing
• Willing to give written informed consent and/or assent

You may not qualify if:

• History of diagnosis of ADHD
• History of known neurological disease or insult (e.g., head trauma with LOC, skull fracture, past or present migraine headaches, seizure disorders)
• Major Medical Disorders
• Past/present alcohol or substance abuse or dependence
• Current or past DSM-IV disorder, screened by the computerized SCID I \& II, and reviewed by investigator
• Any major medical or neurological condition that could affect motor activity or attention (e.g. Parkinson's, MS, dementia)
• Currently ill with cold/flu/infections which may compromise their ability to perform the computer task

Sponsors & Collaborators

• BioBehavioral Diagnostics Company: lead

Study Sites (1)

The Focus Center

Clinton, Utah, 84015, United States

Location

Related Publications (1)

• 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.

  PMID: 29116540 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Calvin R. Sumner, MD, CMO, Sr. VP for Clinical Development
• Organization: BioBDx

calvin_sumner@biobdx.com

978-431-5103

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2011
• First Posted: March 4, 2011
• Study Start: March 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: November 27, 2013
• Results First Posted: October 30, 2013

Record last verified: 2013-11

Locations

US (1)