An Efficient Combination Therapy with Lisdexamfetamine Dimesylate and Topiramate in Improving Binge Eating Scale & Metabolic Profile in Binge Eating Disorder: A Randomized Control Trial
Farnoosh Mokhtari1, Mahsa Taghavi1, Mina Mashayekh2
1Medical School, Islamic Azad University, Kazeroon branch, Kazeroon, Iran
2Shiraz Nephron-Urology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran
Correspondence to: Mahsa Taghavi
Department of Psychiatry, Islamic Azad University, Kazeroon branch, Kilometer 5 of Kazeroon-Bushehr road, kazeroon 7319866451, Iran
E-mail: dr_mahsataghavi@yahoo.com
ORCID: https://orcid.org/0000-0002-0170-5710
Received: December 11, 2023; Revised: April 4, 2024; Accepted: May 13, 2024; Published online: June 27, 2024.
© The Korean College of Neuropsychopharmacology. All rights reserved.

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Abstract
Objective: Comprehensive evaluation of lisedexamfetamine dimesylate (LDX) alone and in combination with topiramate (TPM) was done for treatment of binge eating disorder (BED) in adults aged 18−55 years.
Methods: In the present randomized clinical trial study, 93 patients were selected by convenience sampling method and were allocated to two groups of 48 and 45 using the permuted block randomization method. This study was conducted from January to September 2022 in Shiraz, Iran. Patients received LDX (n = 48) or LDX plus TPM. Average dose of LDX was 37.5 mg/day and 38 mg/day in the first and second group respectively. The second group (n = 45) also received TPM with average dose of 77.7 mg/day.
Results: Twelve weeks treatment caused significant higher mean reduction in level of triglyceride (73.68 vs. 58.97 respectively, p = 0.024), low density lipo-protein (LDL) (9.66 vs. 5.16 respectively, p < 0.001) and body mass index (5.48 vs. 3.41 respectively, p < 0.001) with TPM plus LDX and also greater significant improvement (p < 0.001) in binge eating scale compared to use of LDX alone. Combination therapy with TPM and LDX had better tolerability and lower adverse events such as insomnia (p < 0.001), paresthesia (p = 0.001), confusion (p = 0.035) and ataxia (p = 0.009) compared to monotherapy in BED.
Conclusion: The combinative treatment was more effective than single drug in terms of higher tolerability, safety and causing lesser adverse events for BED patients. However, more studies with larger samples are needed.
Keywords: Binge-eating disorder; Lisedexamfetamine dimesylate; Topiramate


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