Clinical Psychopharmacology and Neuroscience Papers in Press available online.

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 Mokhtari, Mahsa Taghavi , Mina Mashayekh
Islamic Azad university, Kazeroon branch, Shiraz nephron-urology research center, Shiraz university of medical sciences
Objective: Comprehensive evaluation of lisedexamfetamine dimesylate (LDX) alone and in combination with topiramate (TPM) was done for treatment of BED in adults aged 18-55 years who were referred to medical clinics of Shiraz, Iran.
Method: 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. LDX was titrated from 30 mg/day to a maximum of 50mg/day in both groups, with average dose of 37.5 mg/day and 38 mg/day in the first and second group respectively. The second group (n=45) also received TPM, started with 25 mg/day and if tolerated, increased to max dose of 150 mg/day with average dose of 77.7 mg/day.
Results: Twelve weeks treatment caused significant higher mean reduction in level of triglyceride (TG) (73.68 vs 58.97 respectively, P=0.024), low density lipo-protein (LDL) (9.66 vs 5.16 respectively, P<0.001) and BMI (5.48 vs 3.41 respectively, P<0.001) with TPM plus LDX and also greater significant improvement (P<0.001) in BES 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 to clarify efficacy of combination of TPM plus LDX compared to using these medications separately.
Accepted Manuscript [Submitted on 2023-11-23, Accepted on 2024-05-13]