Effects of Polyunsaturated Fatty Acids on the Visual Memory of Children With Attention Deficit Hyperactivity Disorder

NCT03299647 | Unknown DMC

• 1 other identifier: 201705134RINC
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators anticipate to identify specific polyunsaturated fatty acids that show significant differences between ADHD and control groups. In addition, these findings may offer more biological understanding in explaining the relationship between polyunsaturated fatty acids and visual memory among children with ADHD. The results will significantly contribute to the knowledge of the pathophysiological mechanisms of ADHD, especially the polyunsaturated fatty acids related to the behavioral/visual memory deficits of ADHD.

Conditions

Attention-deficit/Hyperactivity Disorder

Keywords

Attention-deficit/hyperactivity disorder; behavioral deficits; cognitive function; polyunsaturated fatty acids; visual memory

Outcome Measures

Primary Outcomes (1)

• Psychiatric interview

  Subjects will be interviewed by Chinese Version of the Kiddie Epidemiologic version of the Schedule for Affective Disorders and Schizophrenia (K-SADS-E)

  1 hour

Secondary Outcomes (3)

• Continuous Performance Test (CPT)

  15 minutes

• Wechsler Intelligence Scale for Children-3rd edition (WISC-III)

  1.5 hours

• Cambridge Neuropsychological Test Automated Batteries (CANTAB)

  1.5 hours

Study Arms (2)

ADHD group

Subjects with clinical diagnosis of ADHD according to the DSM-V criteria

TD group

Typically development controls without lifetime diagnosis with ADHD

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The researchers plan to recruit 35 ADHD subjects and 35 control subjects.

You may qualify if:

• Patients with ADHD are eligible to be included in this study only if they meet all of the following criteria:
• Patients will be outpatients who are between 7 and 18 years of age.
• Patients must have ADHD that meet the Diagnostic and Statistical Manual of Mental disorders, 5th edition (DSM-V) disease diagnostic criteria assessed by the investigator's clinical evaluation, as well as confirmed by the Chinese version of the Schedule for Affective Disorders and Schizophrenia for School-Age Children-Epidemiological Version (K-SADS-E).
• Patients must have a Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S) score \> 4 at baseline.
• Patients must be psychotropic drug-naïve. Patients will be considered to be drug-naïve if they have never received medications specifically to treat ADHD.
• Patients and parents (or legal representative) must have a degree of understanding sufficient to be able to communicate suitably with the investigator.
• Patients must be of normal intelligence in the judgment of the investigator. Normal intelligence is defined as achieving a score of 80 or more when IQ testing is administrated.
• Patients must have been judged by the investigator to be reliable to keep appointments for clinic visits and all tests, including neuropsychological testing and venipunctures.

You may not qualify if:

• Patients will be excluded from the study if they meet any of the following criteria:
• Patients with current or past history of schizophrenia, schizoaffective Disorder, organic psychosis, bipolar I or II disorder, autism, or autism spectrum disorder. Other comorbid psychiatric disorders are not excluded if the ADHD symptoms are the primary source of impairment for the patient.
• Patients with a history of any seizure disorder (other than febrile convulsion) or patients who are taking anticonvulsants for seizure control.
• Patients have been at serious suicidal risk, determined by the investigator.
• Patients with a history of alcohol or drug abuse within the past 3 months, or who are currently using alcohol, drugs of abuse, or any described or over-the-counter medication in a manner that the investigator considers indicative of abuse.
• Patients with cardiovascular disease or other conditions that could be aggravated by an increased heart rate or increased blood pressure.
• Patients who are likely to need Chinese medicine or health-food supplements that have central nervous system activity.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan Univeristy Hospital

Taipei, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The biospecimen includes plasma and DNA of the participants.

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

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

Study Officials

• Chi-Yung Shang, MD

  Dept of Psychiatry, National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chi-Yung Shang, MD

CONTACT

886-2-23123456 Ext. 66965; cyshang@ntu.edu.tw

Study Design

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

Study Record Dates

• First Submitted: September 25, 2017
• First Posted: October 3, 2017
• Study Start: July 31, 2017
• Primary Completion: July 30, 2018
• Study Completion: July 30, 2018
• Last Updated: October 13, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)