UnknownNot Applicable

Metabolic Pathway of Tryptophan and Executive Dysfunction in Children With Attention Deficit Hyperactivity Disorder

Taiwan240 participantsStarted 2019-04-01

Plain-language summary

The present project is to identify the relationship between ADHD and the metabolites of tryptophan.

Age range7 Years – 18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

Serum level of Indolepropionic acid [IPA]

Timeframe: 1 year

Serum level of indoleacetic acid [IAA]

Timeframe: 1 year

Serum level of kynurenic acid [KYNA]

Timeframe: 1 year

NCT IDNCT03901859

SponsorNational Taiwan University Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-03-31

Chi-Yung Shang

Who can participate

Age range7 Years – 18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.