Efficacy and Safety of Tipepidine as Adjunctive Therapy in Children with Attention-Deficit / Hyperactivity Disorder: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial.
Psychiatry Clin Neurosci. 2019 Jul 11;:
Authors: Dehbozorghi S, Bagheri S, Moradi K, Shokraee K, Mohammadi MR, Akhondzadeh S
AIM: This study aimed to evaluate the efficacy and safety of tipepidine as an add-on to methylphenidate in drug treatment of Attention-deficit /hyperactivity disorder (ADHD).
METHODS: This study was an 8-week, randomized, parallel group, double-blind, placebo-controlled trial recruiting 53 ADHD-diagnosed children. Patients were randomly divided to receive methylphenidate + tipepidine or methylphenidate + placebo for eight weeks. Participants were assessed using the Parent version of ADHD Rating Scale-IV and the Clinical Global Impression scale at baseline, at weeks four, and at the end of the trial. Moreover, the safety and tolerability of the treatment strategies were compared.
RESULTS: General linear model repeated measures analysis demonstrated a significant effect for time-treatment interaction on total and hyperactivity-impulsivity subscales of the Parent ADHD Rating Scale-IV during the trial period (Greenhouse-Geisser corrected: F = 3.45, df = 1.52, p = 0.049, and F = 5.17, df = 1.52, p = 0.014, respectively). The effect for time-treatment interaction, however, was not significant on Clinical Global Impression- Severity scale (Greenhouse-Geisser corrected: F = 1.79, df = 1.43, p = 0.182). The frequencies of adverse events were reported similar between the two groups.
CONCLUSION: Eight weeks of treatment with tipepidine, as a supplementary medication, resulted in satisfactory efficacy and safety of the adjuvant therapy in management of patients with ADHD. However, rigorous investigations should be considered containing larger sample sizes, more extended treatment periods, and dose-responses. This article is protected by copyright. All rights reserved.
PMID: 31294924 [PubMed – as supplied by publisher]