Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03018574
Recruitment Status : Completed
First Posted : January 12, 2017
Last Update Posted : February 26, 2018
Sponsor:
Collaborator:
Soochow University
Information provided by (Responsible Party):
Xijing Hospital

Brief Summary:

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.

Condition or disease
Gene Product Sequence Variation

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Candidate Gene Screening for 6-14 Year Old Patients With ADHD (Attention Deficit/ Hyperactivity Disorder)
Study Start Date : May 2016
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017


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



Primary Outcome Measures :
  1. Gene point mutation in the genome of ADHD patients and healthy controls [ Time Frame: 2016-2017 ]

Biospecimen Retention:   Samples With DNA
Whole blood


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03018574


Locations
Layout table for location information
China, Shaanxi
Xijing Hospital of the Fourth Military Medical University
Xi'an, Shaanxi, China, 710032
Sponsors and Collaborators
Xijing Hospital
Soochow University
Investigators
Layout table for investigator information
Principal Investigator: Yan Li, PhD&MD Xijing hospital of The fourth military medical university

Publications of Results:
Layout table for additonal information
Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT03018574     History of Changes
Other Study ID Numbers: KY20163381
First Posted: January 12, 2017    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Publish all data in a paper
Additional relevant MeSH terms:
Layout table for MeSH terms
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders