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A Preliminary Randomized Controlled Trial of Different Treatment Regimens for Melancholic Depression

Background: Fluoxetine, bupropion, cognitive behavioral therapy (CBT), and physical therapies (modified electroconvulsive treatment or repetitive transcranial magnetic stimulation) can be used to manage melancholic depression. Objective: To compare the efficacy and safety of various treatments in pa...

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Published in:Neuropsychiatric disease and treatment 2021-01, Vol.17, p.2441-2449
Main Authors: Wang, Yun, Liu, Xiaohua, Peng, Daihui, Wu, Yan, Su, Yun'ai, Xu, Jia, Ma, Xiancang, Li, Yi, Shi, Jianfei, Cheng, Xiaojing, Rong, Han, Fang, Yiru
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container_title Neuropsychiatric disease and treatment
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creator Wang, Yun
Liu, Xiaohua
Peng, Daihui
Wu, Yan
Su, Yun'ai
Xu, Jia
Ma, Xiancang
Li, Yi
Shi, Jianfei
Cheng, Xiaojing
Rong, Han
Fang, Yiru
description Background: Fluoxetine, bupropion, cognitive behavioral therapy (CBT), and physical therapies (modified electroconvulsive treatment or repetitive transcranial magnetic stimulation) can be used to manage melancholic depression. Objective: To compare the efficacy and safety of various treatments in patients with melancholic depression. Methods: This was a preliminary multicenter randomized controlled trial that included patients with depression in their first or recurrent acute episode between September 2016 and June 2019, and randomized to fluoxetine, fluoxetine+CBT, fluoxetine+bupropion, and fluoxetine+bupropion+brain stimulation. The primary endpoint was the decrease in the 17-item Hamilton Depression Rating Scale (17-HDRS). The secondary endpoint included the scores from the Quick Inventory of Depressive Symptomatology (QIDS-SR), QOL-6, and safety. Adverse events (AEs) were monitored. The follow-ups were performed at the end of the 0th, 2nd, 4th, 6th, 8th, and 12th weeks of treatment. Results: Finally, 113 patients were included in the analyses: fluoxetine (n=37), fluoxetine +CBT (n=27), fluoxetine+bupropion (n=34), and fluoxetine+bupropion+brain stimulation (n=15). The 17-HDRS and QIDS-SR scores decreased in all four groups (all P
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Objective: To compare the efficacy and safety of various treatments in patients with melancholic depression. Methods: This was a preliminary multicenter randomized controlled trial that included patients with depression in their first or recurrent acute episode between September 2016 and June 2019, and randomized to fluoxetine, fluoxetine+CBT, fluoxetine+bupropion, and fluoxetine+bupropion+brain stimulation. The primary endpoint was the decrease in the 17-item Hamilton Depression Rating Scale (17-HDRS). The secondary endpoint included the scores from the Quick Inventory of Depressive Symptomatology (QIDS-SR), QOL-6, and safety. Adverse events (AEs) were monitored. The follow-ups were performed at the end of the 0th, 2nd, 4th, 6th, 8th, and 12th weeks of treatment. Results: Finally, 113 patients were included in the analyses: fluoxetine (n=37), fluoxetine +CBT (n=27), fluoxetine+bupropion (n=34), and fluoxetine+bupropion+brain stimulation (n=15). The 17-HDRS and QIDS-SR scores decreased in all four groups (all P&lt;0.05). There were no differences in the 17-HDRS scores among the four groups at the end of treatment (P=0.779), except for fluoxetine alone showing a better response regarding self-consciousness than fluoxetine+bupropion. The QOL-6 scores increased in all four groups. The occurrence of AEs among the four groups showed no significant difference (P=0.053). Conclusion: This preliminary trial suggests that all four interventions (fluoxetine, fluoxetine +CBT, fluoxetine+bupropion, and fluoxetine+bupropion+brain stimulation) achieved similar response and remission rates in patients with melancholic depression, but that fluoxetine had a better effect on self-consciousness than fluoxetine+bupropion. The safety profile was manageable. Keywords: major depressive disorder, melancholic depression, fluoxetine, bupropion, cognitive behavioral therapy, brain stimulation</description><identifier>ISSN: 1178-2021</identifier><identifier>ISSN: 1176-6328</identifier><identifier>EISSN: 1178-2021</identifier><identifier>DOI: 10.2147/NDT.S303938</identifier><identifier>PMID: 34326642</identifier><language>eng</language><publisher>Auckland: Dove Medical Press Limited</publisher><subject>Adverse events ; Angina pectoris ; Antidepressants ; Behavior modification ; brain stimulation ; Bupropion ; Care and treatment ; Clinical trials ; Cognitive ability ; Cognitive behavioral therapy ; Cognitive therapy ; Consciousness ; Depression, Mental ; Drugs ; Electroconvulsive therapy ; Fluoxetine ; Magnetic brain stimulation ; Magnetic fields ; major depressive disorder ; melancholic depression ; Mental depression ; Normal distribution ; Original Research ; Patients ; Psychotherapy ; Remission ; Remission (Medicine) ; Safety ; Suicides &amp; suicide attempts ; Testing ; Transcranial magnetic stimulation ; Variables</subject><ispartof>Neuropsychiatric disease and treatment, 2021-01, Vol.17, p.2441-2449</ispartof><rights>COPYRIGHT 2021 Dove Medical Press Limited</rights><rights>2021. This work is licensed under https://creativecommons.org/licenses/by-nc/3.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2021 Wang et al. 2021 Wang et al.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c508t-89f2cb84ca763834358e1ed663361ed4263ad170f520f00795a8797e943a63963</cites><orcidid>0000-0003-4338-967X ; 0000-0001-8445-9633 ; 0000-0002-7826-305X ; 0000-0002-8748-9085</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.proquest.com/docview/2562050673/fulltextPDF?pq-origsite=primo$$EPDF$$P50$$Gproquest$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.proquest.com/docview/2562050673?pq-origsite=primo$$EHTML$$P50$$Gproquest$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,885,25753,27924,27925,37012,37013,44590,53791,53793,75126</link.rule.ids></links><search><creatorcontrib>Wang, Yun</creatorcontrib><creatorcontrib>Liu, Xiaohua</creatorcontrib><creatorcontrib>Peng, Daihui</creatorcontrib><creatorcontrib>Wu, Yan</creatorcontrib><creatorcontrib>Su, Yun'ai</creatorcontrib><creatorcontrib>Xu, Jia</creatorcontrib><creatorcontrib>Ma, Xiancang</creatorcontrib><creatorcontrib>Li, Yi</creatorcontrib><creatorcontrib>Shi, Jianfei</creatorcontrib><creatorcontrib>Cheng, Xiaojing</creatorcontrib><creatorcontrib>Rong, Han</creatorcontrib><creatorcontrib>Fang, Yiru</creatorcontrib><title>A Preliminary Randomized Controlled Trial of Different Treatment Regimens for Melancholic Depression</title><title>Neuropsychiatric disease and treatment</title><description>Background: Fluoxetine, bupropion, cognitive behavioral therapy (CBT), and physical therapies (modified electroconvulsive treatment or repetitive transcranial magnetic stimulation) can be used to manage melancholic depression. Objective: To compare the efficacy and safety of various treatments in patients with melancholic depression. Methods: This was a preliminary multicenter randomized controlled trial that included patients with depression in their first or recurrent acute episode between September 2016 and June 2019, and randomized to fluoxetine, fluoxetine+CBT, fluoxetine+bupropion, and fluoxetine+bupropion+brain stimulation. The primary endpoint was the decrease in the 17-item Hamilton Depression Rating Scale (17-HDRS). The secondary endpoint included the scores from the Quick Inventory of Depressive Symptomatology (QIDS-SR), QOL-6, and safety. Adverse events (AEs) were monitored. The follow-ups were performed at the end of the 0th, 2nd, 4th, 6th, 8th, and 12th weeks of treatment. Results: Finally, 113 patients were included in the analyses: fluoxetine (n=37), fluoxetine +CBT (n=27), fluoxetine+bupropion (n=34), and fluoxetine+bupropion+brain stimulation (n=15). The 17-HDRS and QIDS-SR scores decreased in all four groups (all P&lt;0.05). There were no differences in the 17-HDRS scores among the four groups at the end of treatment (P=0.779), except for fluoxetine alone showing a better response regarding self-consciousness than fluoxetine+bupropion. The QOL-6 scores increased in all four groups. The occurrence of AEs among the four groups showed no significant difference (P=0.053). Conclusion: This preliminary trial suggests that all four interventions (fluoxetine, fluoxetine +CBT, fluoxetine+bupropion, and fluoxetine+bupropion+brain stimulation) achieved similar response and remission rates in patients with melancholic depression, but that fluoxetine had a better effect on self-consciousness than fluoxetine+bupropion. The safety profile was manageable. 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Objective: To compare the efficacy and safety of various treatments in patients with melancholic depression. Methods: This was a preliminary multicenter randomized controlled trial that included patients with depression in their first or recurrent acute episode between September 2016 and June 2019, and randomized to fluoxetine, fluoxetine+CBT, fluoxetine+bupropion, and fluoxetine+bupropion+brain stimulation. The primary endpoint was the decrease in the 17-item Hamilton Depression Rating Scale (17-HDRS). The secondary endpoint included the scores from the Quick Inventory of Depressive Symptomatology (QIDS-SR), QOL-6, and safety. Adverse events (AEs) were monitored. The follow-ups were performed at the end of the 0th, 2nd, 4th, 6th, 8th, and 12th weeks of treatment. Results: Finally, 113 patients were included in the analyses: fluoxetine (n=37), fluoxetine +CBT (n=27), fluoxetine+bupropion (n=34), and fluoxetine+bupropion+brain stimulation (n=15). The 17-HDRS and QIDS-SR scores decreased in all four groups (all P&lt;0.05). There were no differences in the 17-HDRS scores among the four groups at the end of treatment (P=0.779), except for fluoxetine alone showing a better response regarding self-consciousness than fluoxetine+bupropion. The QOL-6 scores increased in all four groups. The occurrence of AEs among the four groups showed no significant difference (P=0.053). Conclusion: This preliminary trial suggests that all four interventions (fluoxetine, fluoxetine +CBT, fluoxetine+bupropion, and fluoxetine+bupropion+brain stimulation) achieved similar response and remission rates in patients with melancholic depression, but that fluoxetine had a better effect on self-consciousness than fluoxetine+bupropion. The safety profile was manageable. Keywords: major depressive disorder, melancholic depression, fluoxetine, bupropion, cognitive behavioral therapy, brain stimulation</abstract><cop>Auckland</cop><pub>Dove Medical Press Limited</pub><pmid>34326642</pmid><doi>10.2147/NDT.S303938</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0003-4338-967X</orcidid><orcidid>https://orcid.org/0000-0001-8445-9633</orcidid><orcidid>https://orcid.org/0000-0002-7826-305X</orcidid><orcidid>https://orcid.org/0000-0002-8748-9085</orcidid><oa>free_for_read</oa></addata></record>
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ispartof Neuropsychiatric disease and treatment, 2021-01, Vol.17, p.2441-2449
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1176-6328
1178-2021
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subjects Adverse events
Angina pectoris
Antidepressants
Behavior modification
brain stimulation
Bupropion
Care and treatment
Clinical trials
Cognitive ability
Cognitive behavioral therapy
Cognitive therapy
Consciousness
Depression, Mental
Drugs
Electroconvulsive therapy
Fluoxetine
Magnetic brain stimulation
Magnetic fields
major depressive disorder
melancholic depression
Mental depression
Normal distribution
Original Research
Patients
Psychotherapy
Remission
Remission (Medicine)
Safety
Suicides & suicide attempts
Testing
Transcranial magnetic stimulation
Variables
title A Preliminary Randomized Controlled Trial of Different Treatment Regimens for Melancholic Depression
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