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Center for Global Research Data

Elucidation of the predictive factors for active and placebo drug response on social functioning and quality of life (QOL) in psychiatric illnesses including developmental disorders

Lead Investigator: Yoshie Omachi, National Center of Neurology and Psychiatry
Title of Proposal Research: Elucidation of the predictive factors for active and placebo drug response on social functioning and quality of life (QOL) in psychiatric illnesses including developmental disorders
Vivli Data Request: 7801, 6864
Funding Source: Funded by Japanese Agency for Medical Research and Development
Potential Conflicts of Interest: None

Summary of the Proposed Research:
Attention deficit hyperactivity disorder (ADHD) is a neurodevelopmental disorder characterized by inattention, excessive activity and impulsivity. ADHD is estimated to affect about 6–7% of child and adolescent and few percentages of adult. ADHD significantly affects the quality of life (QOL) of patients and their families. This is an individual participant data (IPD) level meta-analysis for estimating factors leading to improve the quality of life (QOL) in the Japanese patient with ADHD, in order to reduce the burden on them and their families. This research collects placebo-controlled clinical studies evaluated QOL, makes integrated data set and identifies factors leading to improve the QOL in the patient with ADHD by statistical analyses.

Requested Studies:

A Double-blind, Placebo-controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of JNS001 in Adults With Attention-Deficit/Hyperactivity Disorder at Doses of 18 mg, 36 mg, 54 mg, or 72 mg Per Day
Data Contributor: Johnson & Johnson
Study ID: NCT01323192
Sponsor ID: CR017755

A Double-Blind Placebo-Controlled Asian Study of Atomoxetine Hydrochloride in the Treatment of Adult Patients With Attention-Deficit/Hyperactivity Disorder (ADHD)
Data Contributor: Lilly
Study ID: NCT00962104
Sponsor ID: 12107

Tipepidine in Children With Attention Deficit/Hyperactivity Disorder (AD/HD): a Double-blind, Placebo-controlled Trial
Brief Summary: Tipepidine (3-[di-2-thienylmethylene]-1-methylpiperidine) has been used solely as a nonnarcotic antitussive in Japan since 1959. The safety of tipepidine in children and adults has already been established. It is reported that tipepidine inhibits G-protein-coupled inwardly rectifying potassium (GIRK)-channel currents. The inhibition of GIRK channels by tipepidine is expected to modulate the level of monoamines in the brain. We put forward the hypothesis that tipepidine can improve attention deficit/hyperactivity disorder (ADHD) symptoms by modulating monoaminergic neurotransmission through the inhibition of GIRK channels. The purpose of this double-blind, placebo-controlled trial is to confirm whether treatment with tipepidine can improve symptoms in pediatric patients with ADHD.
Data Contributor: I WILL BRING MY OWN
Study ID: NCT02305134

A Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Comparison of Fixed-Dose Ranges of Atomoxetine Hydrochloride in Child Outpatients with Attention-Deficit/Hyperactivity Disorder
Data Contributor: Lilly
Study ID: NCT00191295
Sponsor ID: 5285

(Note: Additional study added as part of Data Request 7801)

Shionogi study (PMID:32297719)
Data Contributor: Shionogi
Sponsor ID: JapicCTI-163231