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

11. oktober 2017 oppdatert av: National Taiwan University Hospital
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.

Studieoversikt

Status

Ukjent

Forhold

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Forventet)

70

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Taiwan
      • Taipei, Taiwan
        • Rekruttering
        • National Taiwan Univeristy Hospital
        • Ta kontakt med:
          • Chi-Yung Shang, MD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

7 år til 18 år (Barn, Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
TD gruppe
Typisk utviklingskontroll uten livstidsdiagnose med ADHD
ADHD gruppe
Personer med klinisk diagnose ADHD i henhold til DSM-V-kriteriene

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Psykiatrisk intervju
Tidsramme: 1 time
Forsøkspersonene vil bli intervjuet av kinesisk versjon av Kiddie Epidemiologic-versjonen av Schedule for Affective Disorders and Schizophrenia (K-SADS-E)
1 time

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Continuous Performance Test (CPT)
Tidsramme: 15 minutes
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
Wechsler Intelligence Scale for Children-3rd edition (WISC-III)
Tidsramme: 1.5 hours
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
Cambridge Neuropsychological Test Automated Batteries (CANTAB)
Tidsramme: 1.5 hours
The CANTAB is a computer-administered, nonverbal (visually-presented) set of neuropsychological tasks developed at the University of Cambridge.
1.5 hours

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

National Taiwan University Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

31. juli 2017

Primær fullføring (Forventet)

30. juli 2018

Studiet fullført (Forventet)

30. juli 2018

Datoer for studieregistrering

Først innsendt

25. september 2017

Først innsendt som oppfylte QC-kriteriene

1. oktober 2017

Først lagt ut (Faktiske)

3. oktober 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

13. oktober 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. oktober 2017

Sist bekreftet

1. september 2017

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 201705134RINC

Plan for individuelle deltakerdata (IPD)

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Studerer et amerikansk FDA-regulert medikamentprodukt

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Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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