Tipepidine in children with attention deficit/hyperactivity disorder: a 4-week, open-label, preliminary study
Tsuyoshi Sasaki1, Kenji Hashimoto2, Masumi Tachibana3
1Department of Child Psychiatry, Chiba University Hospital, Chiba, Japan ; Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan.
Insights
Tipepidine may be a promising new treatment for pediatric attention deficit/hyperactivity disorder (ADHD). This pilot study found significant ADHD symptom improvement with tipepidine, with good tolerability.
Area of Science:
- Neuroscience
- Pharmacology
- Pediatric Psychiatry
Background:
- Tipepidine, an antitussive since 1959, inhibits GIRK channels, potentially modulating brain monoamines.
- Established safety profile in children and adults.
- Hypothesized to improve ADHD symptoms via monoaminergic neurotransmission modulation.
Purpose of the Study:
- To investigate the efficacy of tipepidine in improving symptoms of pediatric attention deficit/hyperactivity disorder (ADHD).
Main Methods:
- Open-label, 4-week pilot study.
- Ten pediatric ADHD subjects (mean age 9.9 years) received 30 mg/day oral tipepidine hibenzate.
- Assessed using ADHD Rating Scale IV (ADHD-RS) and Das-Naglieri Cognitive Assessment System (DN-CAS).
Main Results:
- Significant improvement in all ADHD-RS scores (total, hyperactive, inattentive) (P<0.001).
- Mild trend of improvement in DN-CAS total scores (P=0.093).
- Tipepidine was well tolerated; no discontinuations due to side effects.
Conclusions:
- Tipepidine shows potential as an effective alternative treatment for pediatric ADHD.
- Further randomized, double-blind trials are necessary to confirm efficacy.
Background:
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 open-label trial was to confirm whether treatment with tipepidine can improve symptoms in pediatric patients with ADHD.
Subjects And Methods:
This was a 4-week, open-label, proof-of-efficacy pilot study for pediatric subjects with ADHD. Ten pediatric ADHD subjects (70% male; mean age, 9.9 years; combined [inattentive and hyperactive/impulsive] subtype, n=7; inattentive subtype, n=3; hyperimpulsive subtype, n=0) received tipepidine hibenzate taken orally at 30 mg/day for 4 weeks. All subjects were assessed using the ADHD Rating Scale IV (ADHD-RS), Japanese version, and the Das-Naglieri Cognitive Assessment System (DN-CAS), Japanese version.
Results:
A comparison of baseline scores and 4-week end-point scores showed that all the ADHD-RS scores (total scores, hyperimpulsive subscores, and inattentive subscores) improved significantly (P<0.001). Furthermore, a comparison of baseline DN-CAS total scores and 4-week end-point scores showed a mild trend of improvement (P=0.093). Tipepidine was well tolerated, with no patients discontinuing medication because of side effects.
Conclusion:
Our pilot study suggests that tipepidine therapy may prove to be an effective alternative treatment for pediatric patients with ADHD. Nonetheless, more detailed randomized, double-blind trials are needed to confirm tipepidine's efficacy.
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