NCT03018574

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. 1.Using Qiagen kit to extract the genomic DNA of 200 microliters of blood.
  2. 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. 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. 4.Using the chi square analysis and other statistical methods to determine the relationship between the mutations and susceptibility to ADHD.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 12, 2017

Completed
Last Updated

February 26, 2018

Status Verified

January 1, 2017

Enrollment Period

8 months

First QC Date

January 11, 2017

Last Update Submit

February 22, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Gene point mutation in the genome of ADHD patients and healthy controls

    2016-2017

Study Arms (2)

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

Eligibility Criteria

Age6 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital of the Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

Location

Related Publications (3)

  • Won H, Mah W, Kim E, Kim JW, Hahm EK, Kim MH, Cho S, Kim J, Jang H, Cho SC, Kim BN, Shin MS, Seo J, Jeong J, Choi SY, Kim D, Kang C, Kim E. GIT1 is associated with ADHD in humans and ADHD-like behaviors in mice. Nat Med. 2011 May;17(5):566-72. doi: 10.1038/nm.2330. Epub 2011 Apr 17.

  • Salatino-Oliveira A, Genro JP, Chazan R, Zeni C, Schmitz M, Polanczyk G, Roman T, Rohde LA, Hutz MH. Association study of GIT1 gene with attention-deficit hyperactivity disorder in Brazilian children and adolescents. Genes Brain Behav. 2012 Oct;11(7):864-8. doi: 10.1111/j.1601-183X.2012.00835.x. Epub 2012 Sep 7.

  • Vegt R, Bertoli-Avella AM, Tulen JH, de Graaf B, Verkerk AJ, Vervoort J, Twigt CM, Maat-Kievit A, van Tuijl R, van der Lijn M, Hengeveld MW, Oostra BA. Genome-wide linkage analysis in a Dutch multigenerational family with attention deficit hyperactivity disorder. Eur J Hum Genet. 2010 Feb;18(2):206-11. doi: 10.1038/ejhg.2009.148. Epub 2009 Aug 26.

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

Study Officials

  • Yan Li, PhD&MD

    Xijing hospital of The fourth military medical university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2017

First Posted

January 12, 2017

Study Start

May 1, 2016

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

February 26, 2018

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will share

Publish all data in a paper

Locations