Candidate Gene Screening for Attention Deficit/Hyperactive Disorder (ADHD)

February 22, 2018 updated by: Xijing Hospital

Candidate Gene Screening for 6-14 Year Old Patients With ADHD (Attention Deficit/ Hyperactivity Disorder)

Source: Sample bank of Xijing Hospital and Children's Hospital Affiliated to Soochow University; Sample form: Whole blood; Estimated number of samples: 100 patients with ADHD and age, sex matched healthy controls; Case exclusion criteria: all kinds of neuropsychiatric disorders, IQ value of less than 70;

Study protocol:

  1. Using Qiagen kit to extract the genomic DNA of 200 microliters of blood.
  2. UV spectrophotometer test DNA purity of 260/280 close to 1.8 (1.8 ± 0.05), the concentration of 100ng/μL or more before the next sequencing.
  3. The extracted genomic DNA will be sent to Sangon Biology Engineering Limited Company (Shanghai) and sequenced to find candidate mutations related to ADHD risk sequence. According to NIH gene database, the longest transcript of NDRG2 (ID: 57447 gene, https://www.ncbi.nlm.nih.gov/nuccore/NC_000014.9? Report=genbank&from=21016763&to=21070872&strand=true) (a total of 17 exons and 16 introns and the gene 5 'UTR and 3' UTR region) will be alignmented sequences to find potential mutations.
  4. Using the chi square analysis and other statistical methods to determine the relationship between the mutations and susceptibility to ADHD.

Study Overview

Status

Completed

Conditions

Detailed Description

Source: Sample bank of Xijing Hospital and Children's Hospital Affiliated to Soochow University; Sample form: Whole blood; Estimated number of samples: 100 patients with ADHD and age, sex matched healthy controls; Case exclusion criteria: all kinds of neuropsychiatric disorders, IQ value of less than 70;

Study protocol:

  1. Using Qiagen kit to extract the genomic DNA of 200 microliters of blood. (1) melt frozen blood at room temperature; (2) take the blood of 0.2 ml into a sterile anti coagulation centrifuge tube, add an equal volume of PBS phosphate buffer, after fully mixing 12000rpm centrifugation 5min, discard supernatant; (3) 66.7 L STE 2.4 L, 20% SDS, 37 DEG C water bath 1h; (4) protease K plus 1 20mg/ml l mix, 55 DEG C water bath digestion overnight (10 ~ 14h); (5) the digested samples treated with Tris saturated phenol, shake well, 12000rpm centrifugal 10min; (6) the upper aqueous phase to a sterile centrifuge tube; adding volume of Tris saturated phenol, shake well, 12000rpm centrifugal 10min; (7) the upper aqueous phase was transferred to another sterile centrifuge tube, and an equal volume of phenol was added: chloroform: isoamyl alcohol (25: 24: 1). The oscillation of the vortex was fully mixed, and the 12000rpm was centrifuged to 10min; (8) the upper aqueous phase was transferred to another sterile centrifuge tube, and an equal volume of chloroform was added: iso amyl alcohol (24: 1), which was fully vibrated and mixed with 12000rpm centrifugation 10min; (9) transfer the supernatant to another sterile centrifuge tube; adding 2 times volume ethanol, the volume level of sodium acetate 1/10 shake, until the flocculent precipitation of DNA visible; (10) the sample is placed at -20 DEG C refrigerator freezer 30min or ice bath for 15 ~ 20min, after removal of 12000rpm centrifugal 10min again, so that DNA precipitation; (11) the gun head will pick DNA to another sterile centrifugal tube, with the amount of 70% ethanol washing and shaking, to wash out impurities DNA; (12) out of ethanol, DNA by vacuum drying or dry naturally, TE buffer adding dissolution, -20 stored at standby.
  2. UV spectrophotometer test DNA purity of 260/280 close to 1.8 (1.8 ± 0.05), the concentration of 100ng/μL or more before the next sequencing.
  3. The extracted genomic DNA will be sent to Sangon Biology Engineering Limited Company (Shanghai) and sequenced to find candidate mutations related to ADHD risk sequence. According to NIH gene database, the longest transcript of NDRG2 (ID: 57447 gene, https://www.ncbi.nlm.nih.gov/nuccore/NC_000014.9? Report=genbank&from=21016763&to=21070872&strand=true) (a total of 17 exons and 16 introns and the gene 5 'UTR and 3' UTR region) will be alignmented sequences to find potential mutations.
  4. Using the chi square analysis and other statistical methods to determine the relationship between the mutations and susceptibility to ADHD.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Xijing hospital of The fourth military medical university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 14 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Diagnoses of the children with ADHD were made in Xijing Hospital and Children's Hospital Affiliated to Soochow University according to criteria described in the Diagnostic and Statistical Manual of Mental Disorders. Children with ADHD had an IQ score above 70.

Description

Inclusion Criteria:

  • Diagnoses of the children with ADHD were made in Xijing Hospital and Children's Hospital Affiliated to Soochow University according to criteria described in the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV). Children with ADHD had an IQ score above 70.

Exclusion Criteria:

  • Children who had a past history of or were currently affected by neurological diseases, including convulsive disorders or brain damage; or who had any evidence of comorbid psychiatric conditions, such as Tourette's syndrome, IQ below 70, pervasive developmental disorder (autism), bipolar disorder, psychosis, language difficulties or learning disorders (reading disorders, mathematics disorders and disorders of written expression).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
ADHD-patients
The whole blood sample from diagnoses of the children 6-14 years old with ADHD. Diagnoses of the children with ADHD were made in Xijing Hospital and Children's Hospital Affiliated to Soochow University according to criteria described in the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV). Children with ADHD had an IQ score above 70.
Controls-healthy children
The whole blood sample from age- and gender- matched healthy 6-14 years old children

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Gene point mutation in the genome of ADHD patients and healthy controls
Time Frame: 2016-2017
2016-2017

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Collaborators

Soochow University

Investigators

  • Principal Investigator: Yan Li, PhD&MD, Xijing hospital of The fourth military medical university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

January 11, 2017

First Submitted That Met QC Criteria

January 11, 2017

First Posted (Estimate)

January 12, 2017

Study Record Updates

Last Update Posted (Actual)

February 26, 2018

Last Update Submitted That Met QC Criteria

February 22, 2018

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20163381

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Publish all data in a paper

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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