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6. Investigating the effectiveness of a smart mental health intervention (inMind) for stress reduction during pharmacological treatment for mild to moderate major depressive disorders: Study protocol for a randomized control trial

Author

Kim, Junhyung, primary, Shin, Cheolmin, additional, Han, Kyu-Man, additional, Lee, Moon-Soo, additional, Jeong, Hyun-Ghang, additional, Pae, Chi-Un, additional, Patkar, Ashwin A., additional, Masand, Prakash M., additional, and Han, Changsu, additional

Published
2023
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11. Vortioxetine: a meta-analysis of 12 short-term, randomized, placebo-controlled clinical trials for the treatment of major depressive disorder

Author

Pae, Chi-Un, Wang, Sheng-Min, Han, Changsu, Lee, Soo-Jung, Patkar, Ashwin A., Masand, Praksh S., and Serretti, Alessandro

Subjects
Major depressive disorder -- Drug therapy, Clinical trials -- Methods, Health, Psychology and mental health
Abstract

Background: Vortioxetine was approved by the U.S. Food and Drug Administration (FDA) in September 2013 for treating major depressive disorder (MDD). Thus far, a number of randomized, double-blind, placebo-controlled clinical trials (RCTs) of vortioxetine have been conducted in patients with MDD. We performed a meta-analysis to increase the statistical power of these studies and enhance our current understanding of the role of vortioxetine in the treatment of MDD. Methods: We performed an extensive search of databases and the clinical trial registry. The mean change in total scores on the 24-item Hamilton Rating Scale for Depression (HAM-D) and the Montgomery-Asberg Depression Rating Scale (MADRS) from the baseline were the primary outcome measures. The secondary efficacy measures were the response and remission rates, as defined by a 50% or greater reduction in HAM-D/MADRS total scores and as a score of 10 or less in the MADRS and 7 or less in the HAM-D total scores at the end of treatment. Results: We included 7 published and 5 unpublished short-term (6-12 wk) RCTs in our meta-analysis. Vortioxetine was significantly more effective than placebo, with an effect size (standardized mean difference [SMD]) of -0.217 (95% confidence interval [CI] -0.313 to -0.122) and with odds ratios (ORs) for response and remission of 1.652 (95% CI 1.321 to 2.067) and 1.399 (95% CI 1.104 to 1.773), respectively. Those treated with vortioxetine did not differ significantly from those treated with selective norepinephrine reuptake inhibitors/agomelatine with regard to the SMD of the primary outcome measure (0.081, -0.062 to 0.223) or for response (OR 0.815, 95% CI 0.585 to 1.135) and remission (OR 0.843, 95% CI 0.575 to 1.238) rates. Discontinuation owing to lack of efficacy (OR 0.541,95% CI 0.308 to 0.950) was significantly less common among those treated with vortioxetine than among those who received placebo, whereas discontinuation owing to adverse events (AEs; OR 1.530, 95% CI 1.144 to 2.047) was significantly more common among those treated with vortioxetine than among those receiving placebo. There was no significant difference in discontinuation rates between vortioxetine and comparators owing to inefficacy (OR 0.983, 95% CI 0.585 to 1.650), whereas discontinuation owing to AEs was significantly less common in the vortioxetine than in the comparator group (OR 0.728, 95% CI 0.554 to 0.957). Limitations: Studies examining the role of vortioxetine in the treatment of MDD are limited. Conclusion: Although our results suggest that vortioxetine may be an effective treatment option for MDD, they should be interpreted and translated into clinical practice with caution, as the meta-analysis was based on a limited number of heterogeneous RCTs., Introduction Major depressive disorder (MDD), a common debilitating illness, is one of the leading causes of disability and disease worldwide. (1) Despite the availability of diverse antidepressants, many patients with [...]

Published
2015
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14. Possible modulatory role of ARC gene variants in mood disorders

Author

Crisafulli, Concetta, Calabrò, Marco, Mandelli, Laura, Wang, Sheng Min, Lee, Soo Jung, Han, Changsu, Patkar, Ashwin, Masand, Prakash, Pae, Chi Un, Souery, Daniel, Mendlewicz, Julien, Serretti, Alessandro, Crisafulli, Concetta, Calabrò, Marco, Mandelli, Laura, Wang, Sheng Min, Lee, Soo Jung, Han, Changsu, Patkar, Ashwin, Masand, Prakash, Pae, Chi Un, Souery, Daniel, Mendlewicz, Julien, and Serretti, Alessandro

Abstract

Objective: The genetic background of mood disorders is gradually emerging through the use of large multicenter samples but a detailed phenotyping is complementary in elucidating the role of modulating variants. Methods: In the present paper we focused on the possible modulatory effects of ARC gene variants on two independent mood disorder samples of European (n = 246 bipolar disorder) and Korean (n = 132 bipolar disorder; n = 242 major depressive disorder [MDD]) ancestry. Results: No result survived Bonferroni correction, however we evidenced promising trend toward possible association between ARC gene variants and mood disorder phenotypes. In particular, we evidenced weak correlations of ARC single nucleotide polymorphisms with depressive symptoms severity (evaluated through Hamilton depression rating scale scores) in the MDD Korean (rs7465272) and European (rs11167152) samples. Additionally rs10110456 was found to be related to Family History, while rs7465272 was related to suicide risk in the Korean sample. Finally, rs7465272 was associated with body mass index in the European sample. Conclusion: Overall, ARC gene variants may have a partial role in modulatory effect on treatment efficacy or phenotypes of mood disorders. Further studies, on larger samples may provide a better understanding on the role of ARC gene variants in the symptom severity and treatment outcomes in patients with mood disorders., SCOPUS: ar.j, DecretOANoAutActif, info:eu-repo/semantics/published

Published
2021

19. Possible Modulatory Role of ARC Gene Variants in Mood Disorders

Author

Crisafulli, Concetta, primary, Calabrò, Marco, additional, Mandelli, Laura, additional, Wang, Sheng-Min, additional, Lee, Soo-Jung, additional, Han, Changsu, additional, Patkar, Ashwin, additional, Masand, Prakash, additional, Pae, Chi-Un, additional, Souery, Daniel, additional, Mendlewicz, Julien, additional, and Serretti, Alessandro, additional

Published
2021
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37. ZNF804A Gene Variants Have a Cross-diagnostic Influence on Psychosis and Treatment Improvement in Mood Disorders

Author

Calabrò, Marco, primary, Mandelli, Laura, additional, Crisafulli, Concetta, additional, Nicola, Marco Di, additional, Colombo, Roberto, additional, Janiri, Luigi, additional, Lee, Soo-Jung, additional, Jun, Tae-Youn, additional, Wang, Sheng-Min, additional, Masand, Prakash S., additional, Patkar, Ashwin A., additional, Han, Changsu, additional, Pae, Chi-Un, additional, and Serretti, Alessandro, additional

Published
2020
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