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

Attention-deficit/Hyperactivity Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03299647
• Other study ID #: 201705134RINC
• Status: Recruiting
• Phase: N/A
• First received: September 25, 2017
• Last updated: October 11, 2017
• Start date: July 31, 2017
• Est. completion date: July 30, 2018

Study information

• Verified date: September 2017
• Source: National Taiwan University Hospital
• Contact: Chi-Yung Shang, MD
• Phone: 886-2-23123456 Ext. 66965
• Email: cyshang[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Because attention deficit hyperactivity disorder (ADHD) is an early onset and long-term impairing disorder with tremendous impact on individuals, families, and societies, detection and diagnosis are very important for ADHD. According to the investigators' previous work, children with ADHD have visual memory deficits as well as inattentive deficits. Previous studies show that polyunsaturated fatty acids are associated with cognitive problems in children. Analyzing differences in polyunsaturated fatty acids between children with ADHD and healthy controls could provide insight into underlying disease pathology of cognitive deficits. In this one-year project, the researchers will perform an analysis of polyunsaturated fatty acids in serum to identify potential biomarkers for the visual memory deficits of ADHD.

The purpose of this study is to:

1. To identify the specific polyunsaturated fatty acids of ADHD symptoms;

2. To identify the relationship between specific polyunsaturated fatty acids and visual memory deficits of ADHD.

This is a one-year project. After careful calculation of sample size, the study will recruit 35 children with ADHD, aged 7-18, and 35 healthy controls with matched age, sex and BMI. The investigators will quantify the polyunsaturated fatty acids in serum. The behavioral measures include ADHDRS-IV, SNAP-IV, CBCL, CGI-ADHD-S, SAICA, and Family APGAR-C. The Cambridge Neuropsychological Test Automated Battery (CANTAB) will be used to assess the visual memory of all participants. Conditional logistic regression and partial least squares discriminant analysis will be applied to identify significant polyunsaturated fatty acids for ADHD and visual memory deficits.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: July 30, 2018
• Est. primary completion date: July 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 18 Years

Eligibility

Inclusion Criteria:

Patients with ADHD are eligible to be included in this study only if they meet all of the following criteria:

1. Patients will be outpatients who are between 7 and 18 years of age.

2. 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).

3. Patients must have a Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S) score > 4 at baseline.

4. Patients must be psychotropic drug-naïve. Patients will be considered to be drug-naïve if they have never received medications specifically to treat ADHD.

5. Patients and parents (or legal representative) must have a degree of understanding sufficient to be able to communicate suitably with the investigator.

6. 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.

7. 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.

Exclusion Criteria:

Patients will be excluded from the study if they meet any of the following criteria:

1. 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.

2. Patients with a history of any seizure disorder (other than febrile convulsion) or patients who are taking anticonvulsants for seizure control.

3. Patients have been at serious suicidal risk, determined by the investigator.

4. 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.

5. Patients with cardiovascular disease or other conditions that could be aggravated by an increased heart rate or increased blood pressure.

6. Patients who are likely to need Chinese medicine or health-food supplements that have central nervous system activity.

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention-deficit/Hyperactivity Disorder
• Disease
• Hyperkinesis

Locations

Country	Name	City	State
Taiwan	National Taiwan Univeristy Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Continuous Performance Test (CPT)	The main feature of CPT is that a rapid presentation of visual or auditory stimuli over a definite period of time. The subjects respond by pressing a switch button in response to a critical stimulus.	15 minutes
Secondary	Wechsler Intelligence Scale for Children-3rd edition (WISC-III)	The WISC-III is composed of 13 subtests to test children's cognitive ability of different dimensions, which are grouped into two scores: performance IQ score (7 subtests: Picture Completion, Block Design, Object Assembly, Picture Arrangement, Coding, Symbol Search and Mazes subtests) and verbal IQ score (Information, Comprehension, Arithmetic, Similarities, Digit Span and Vocabulary subtests) (Allen and Thorndike 1995).	1.5 hours
Secondary	Cambridge Neuropsychological Test Automated Batteries (CANTAB)	The CANTAB is a computer-administered, nonverbal (visually-presented) set of neuropsychological tasks developed at the University of Cambridge.	1.5 hours