Identify Peripheral Biomarkers of Symptomatology, Neurocognitive Functions, and Medication Response in ADHD

NCT02074228 | Unknown Phase 4

• 1 other identifier: 201112131MIB
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Attention deficit hyperactivity disorder (ADHD), characterized by inattention, hyperactivity and impulsivity, is an early onset, highly heritable, clinically heterogeneous, long-term impairing disorder with tremendous impact on individuals, families, and societies. It affects 5-10% of school-aged children worldwide (7.5% in Taiwan) and 2-4% of adults. Although the efficacy of medications for ADHD is well demonstrated in clinical trials, substantial numbers of patients fail to remain on therapy, and there is tremendous variability in tolerability and treatment acceptance. It is of great interest to identify biomarkers relating to medication response in ADHD. However, the procedure for obtaining central markers such as PET scan is invasive and expensive. Previous studies have found that mRNA expression of neurochemical markers in circulating blood can reflect the neurochemical levels in the brain. Further studies to identify peripheral biomarkers related to medication response in ADHD are warranted.

Conditions

Attention-deficit/Hyperactivity Disorder

Keywords

Attention-deficit/hyperactivity disorder,; symptomatology,; neurocognitive endophenotype,; medication response

Outcome Measures

Primary Outcomes (1)

• ADHD Rating Scale-IV

  Evaluate the symptom change after medication

  baseline and 12 weeks after treatment

Secondary Outcomes (2)

• SNAP-IV

  Baseline and 12 weeks after treatment

• Safety Questionnaire

  baseline and 12 weeks after treatment

Study Arms (1)

Methylphenidate

EXPERIMENTAL

Methylphenidate (Concerta) 18mg or 36mg 1# qd, 12 weeks

Drug: Methylphenidate (Concerta)

Interventions

Methylphenidate (Concerta) DRUG

Methylphenidate

Eligibility Criteria

• Age: 7 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients will be outpatients who are between 7 and 16 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 may enter the study if, after appropriate medical evaluation, the result does 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 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, 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)

college of Medicine, National Taiwan University

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Chi-Yung Shang, M.D., Ph.D.

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chi-Yung Shang, Ph.D.

CONTACT

+886-2-2312-3456; cyshang@ntu.edu.tw

Shur-Fen Susan Gau, Ph. D

CONTACT

+886-2-2312-3456; Gaushufe@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2012
• First Posted: February 28, 2014
• Study Start: August 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: February 28, 2014

Record last verified: 2014-02

Locations

TW (1)