Pharmacogenetic Studies on Attention Deficit Hyperactivity Disorder

NCT00916786 | Completed DMC

• 1 other identifier: 200812153M
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

The ultimate goal of this study is to find the association between specific polymorphism of candidate genes and medication response in attention deficit hyperactivity disorder (ADHD) patients. These results will lead the investigators' team: (1) to resolve controversies over inconsistent findings in previous pharmacogenetic studies; (2) to study the medication effect on the neuropsychological functions that are useful candidate endophenotypes for ADHD; (3) to delineate the nature and the effect of gene-gene interaction in the drug response of ADHD patients.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Attention-deficit/hyperactivity disorder; pharmacogenetics; molecular genetics; medication response

Study Arms (3)

OROS-methylphenidate

The patients will be randomly assigned to two treatment groups, the OROS-methylphenidate group (n=80) and the atomoxetine group (n=80), respectively.

Atomoxetine group

The patients will be randomly assigned to two treatment groups, the OROS-methylphenidate group (n=80) and the atomoxetine group (n=80), respectively.

Control group

Healthy controls matching for the distribution of age and sex of the case groups

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 sample will consist of 160 drug-naïve ADHD patients and 80 matched normal controls, aged 7-18. The patients will be randomly assigned to two treatment groups, the OROS-methylphenidate group (n=80) and the atomoxetine group (n=80), respectively.

You may qualify if:

• Patients 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, 4th edition (DSM-IV) 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 Visit 1.
• Patients must be psychotropic medication-naïve. Patients will be considered to be medication-naïve if they have never received medications specifically to treat ADHD.
• Patients must have laboratory results, including serum chemistries, hematology, and urine analysis showing no significant abnormalities and no clinical information that should preclude a patient's participation at study entry. A patient with a significant abnormal laboratory result mat enter the study if, after appropriate medical evaluation, the result dose not indicate a serious medical condition that in the investigator's judgment would preclude participation.
• 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, Asperger's disorder, or pervasive developmental 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 severe allergies to more than one class of medications or multiple adverse drug reactions.
• 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 psychotropic medications apart from methylphenidate or atomoxetine, including Chinese medicine or health-food supplements that have central nervous system activity.

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Science and Technology Council, Taiwan: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

Related Publications (3)

• Wu CS, Shang CY, Lin HY, Gau SS. Differential Treatment Effects of Methylphenidate and Atomoxetine on Executive Functions in Children with Attention-Deficit/Hyperactivity Disorder. J Child Adolesc Psychopharmacol. 2021 Apr;31(3):187-196. doi: 10.1089/cap.2020.0146.

  PMID: 33890819 DERIVED

• Chou TL, Chia S, Shang CY, Gau SS. Differential therapeutic effects of 12-week treatment of atomoxetine and methylphenidate on drug-naive children with attention deficit/hyperactivity disorder: A counting Stroop functional MRI study. Eur Neuropsychopharmacol. 2015 Dec;25(12):2300-10. doi: 10.1016/j.euroneuro.2015.08.024. Epub 2015 Sep 8.

  PMID: 26409297 DERIVED

• Shang CY, Pan YL, Lin HY, Huang LW, Gau SS. An Open-Label, Randomized Trial of Methylphenidate and Atomoxetine Treatment in Children with Attention-Deficit/Hyperactivity Disorder. J Child Adolesc Psychopharmacol. 2015 Sep;25(7):566-73. doi: 10.1089/cap.2015.0035. Epub 2015 Jul 29.

  PMID: 26222447 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

The subjects will receive blood withdrawal. The blood sample will be used for establishing lymphoblastoid cell lines, which will be used for molecular genetic experiments.

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

Study Design

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

Study Record Dates

• First Submitted: June 8, 2009
• First Posted: June 10, 2009
• Study Start: August 1, 2009
• Primary Completion: July 31, 2012
• Study Completion: July 31, 2012
• Last Updated: September 2, 2021

Record last verified: 2021-09

Locations

TW (1)