Efficacy and acceptability of lurasidone for bipolar depression: a systematic review and dose–response meta-analysis

Question The optimal dose of lurasidone for bipolar depression is unclear. This study examined its dose–response relationship for efficacy, acceptability, and metabolic/endocrine profiles.Study selection and analysis Five databases and grey literature published until 1 August 2024, were systematical...

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Main Authors: Marco Solmi, Edward Chia-Cheng Lai, Andre F Carvalho, Yu-Kang Tu, Pao-Yen Lin, Ping-Tao Tseng, Chih-Wei Hsu, Chih-Sung Liang, Kuo-Chuan Hung, Eduard Vieta, Yu-Wei Lin, Yang-Chieh Brian Chen
Format: Article
Language:English
Published: BMJ Publishing Group 2024-11-01
Series:BMJ Mental Health
Online Access:https://mentalhealth.bmj.com/content/27/1/e301165.full
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author Marco Solmi
Edward Chia-Cheng Lai
Andre F Carvalho
Yu-Kang Tu
Pao-Yen Lin
Ping-Tao Tseng
Chih-Wei Hsu
Chih-Sung Liang
Kuo-Chuan Hung
Eduard Vieta
Yu-Wei Lin
Yang-Chieh Brian Chen
author_facet Marco Solmi
Edward Chia-Cheng Lai
Andre F Carvalho
Yu-Kang Tu
Pao-Yen Lin
Ping-Tao Tseng
Chih-Wei Hsu
Chih-Sung Liang
Kuo-Chuan Hung
Eduard Vieta
Yu-Wei Lin
Yang-Chieh Brian Chen
author_sort Marco Solmi
collection DOAJ
description Question The optimal dose of lurasidone for bipolar depression is unclear. This study examined its dose–response relationship for efficacy, acceptability, and metabolic/endocrine profiles.Study selection and analysis Five databases and grey literature published until 1 August 2024, were systematically reviewed. The outcomes included efficacy (changes in depression, anxiety, clinical global impression, disability and quality of life), acceptability (dropout, manic switch, suicidality and side effects) and metabolic/endocrine profiles (changes in body weight, glucose, lipid and prolactin levels). Effect sizes were calculated using a one-step dose–response meta-analysis, expressed as standardised mean differences (SMDs), risk ratios (RRs) and mean differences (MDs) with 95% CIs.Findings Five randomised clinical trials (2032 patients, mean treatment duration 6 weeks) indicated that the optimal therapeutic dose of lurasidone (40–60 mg) improved depression (50 mg: SMD −0.60 (95% CI −0.30, –0.89)), anxiety (50 mg: −0.32 (95% CI −0.21, –0.42)), clinical global impression (50 mg: −0.67 (95% CI −0.30, –1.03)) and disability (50 mg: −0.38 (95% CI −0.08, –0.69)). Side effects increased with higher doses (50 mg: RR 1.15 (95% CI 1.05, 1.25); 100 mg: 1.18 (95% CI 1.02, 1.36)), but dropout, manic switch and suicidality did not show a dose–effect relationship. Weight increased at doses<60 mg (40 mg: MD 0.38 (95% CI 0.16, 0.60) kg), while blood glucose levels rose at doses>70 mg (100 mg: 3.16 (95% CI 0.76, 5.57) mg/dL). Prolactin levels increased in both males (50 mg: 3.21 (95% CI 1.59, 4.84) ng/mL; 100 mg: 5.61 (95% CI 2.42, 8.81)) and females (50 mg: 6.64 (95% CI 3.50, 9.78); 100 mg: 5.33 (95% CI 0.67, 10.00)).Conclusions A daily dose of 40–60 mg of lurasidone is a reasonable choice for bipolar depression treatment.Trial registration number INPLASY202430069.
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spelling doaj-art-9c597983173d4dc0a3bd9cb8ebb6a4102024-11-22T05:25:09ZengBMJ Publishing GroupBMJ Mental Health2755-97342024-11-0127110.1136/bmjment-2024-301165Efficacy and acceptability of lurasidone for bipolar depression: a systematic review and dose–response meta-analysisMarco Solmi0Edward Chia-Cheng Lai1Andre F Carvalho2Yu-Kang Tu3Pao-Yen Lin4Ping-Tao Tseng5Chih-Wei Hsu6Chih-Sung Liang7Kuo-Chuan Hung8Eduard Vieta9Yu-Wei Lin10Yang-Chieh Brian Chen11Department of Mental Health, The Ottawa Hospital, Ottawa, Ontario, CanadaSchool of Pharmacy, Institute of Clinical Pharmacy and Pharmaceutical Sciences, College of Medicine, National Cheng Kung University, Tainan, TaiwanInnovation in Mental and Physical Health and Clinical Treatment (IMPACT) Strategic Research Centre, School of Medicine, Barwon Health, Deakin University, Geelong, Victoria, AustraliaInstitute of Health Data Analytics & Statistics, College of Public Health, National Taiwan University, Taipei, TaiwanDepartment of Psychiatry, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, TaiwanProspect Clinic for Otorhinolaryngology & Neurology, Kaohsiung, TaiwanDepartment of Psychiatry, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, TaiwanDepartment of Psychiatry, Beitou Branch, Tri-Service General Hospital, National Defense Medical Center, Taipei, TaiwanDepartment of Anesthesiology, Chi Mei Medical Center, Tainan, TaiwanBipolar and Depressive Disorders Unit, Hospital Clinic, IDIBAPS, CIBERSAM, Institute of Neuroscience, University of Barcelona, Barcelona, Catalonia, SpainDepartment of Psychiatry, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, TaiwanDepartment of Psychiatry, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, TaiwanQuestion The optimal dose of lurasidone for bipolar depression is unclear. This study examined its dose–response relationship for efficacy, acceptability, and metabolic/endocrine profiles.Study selection and analysis Five databases and grey literature published until 1 August 2024, were systematically reviewed. The outcomes included efficacy (changes in depression, anxiety, clinical global impression, disability and quality of life), acceptability (dropout, manic switch, suicidality and side effects) and metabolic/endocrine profiles (changes in body weight, glucose, lipid and prolactin levels). Effect sizes were calculated using a one-step dose–response meta-analysis, expressed as standardised mean differences (SMDs), risk ratios (RRs) and mean differences (MDs) with 95% CIs.Findings Five randomised clinical trials (2032 patients, mean treatment duration 6 weeks) indicated that the optimal therapeutic dose of lurasidone (40–60 mg) improved depression (50 mg: SMD −0.60 (95% CI −0.30, –0.89)), anxiety (50 mg: −0.32 (95% CI −0.21, –0.42)), clinical global impression (50 mg: −0.67 (95% CI −0.30, –1.03)) and disability (50 mg: −0.38 (95% CI −0.08, –0.69)). Side effects increased with higher doses (50 mg: RR 1.15 (95% CI 1.05, 1.25); 100 mg: 1.18 (95% CI 1.02, 1.36)), but dropout, manic switch and suicidality did not show a dose–effect relationship. Weight increased at doses<60 mg (40 mg: MD 0.38 (95% CI 0.16, 0.60) kg), while blood glucose levels rose at doses>70 mg (100 mg: 3.16 (95% CI 0.76, 5.57) mg/dL). Prolactin levels increased in both males (50 mg: 3.21 (95% CI 1.59, 4.84) ng/mL; 100 mg: 5.61 (95% CI 2.42, 8.81)) and females (50 mg: 6.64 (95% CI 3.50, 9.78); 100 mg: 5.33 (95% CI 0.67, 10.00)).Conclusions A daily dose of 40–60 mg of lurasidone is a reasonable choice for bipolar depression treatment.Trial registration number INPLASY202430069.https://mentalhealth.bmj.com/content/27/1/e301165.full
spellingShingle Marco Solmi
Edward Chia-Cheng Lai
Andre F Carvalho
Yu-Kang Tu
Pao-Yen Lin
Ping-Tao Tseng
Chih-Wei Hsu
Chih-Sung Liang
Kuo-Chuan Hung
Eduard Vieta
Yu-Wei Lin
Yang-Chieh Brian Chen
Efficacy and acceptability of lurasidone for bipolar depression: a systematic review and dose–response meta-analysis
BMJ Mental Health
title Efficacy and acceptability of lurasidone for bipolar depression: a systematic review and dose–response meta-analysis
title_full Efficacy and acceptability of lurasidone for bipolar depression: a systematic review and dose–response meta-analysis
title_fullStr Efficacy and acceptability of lurasidone for bipolar depression: a systematic review and dose–response meta-analysis
title_full_unstemmed Efficacy and acceptability of lurasidone for bipolar depression: a systematic review and dose–response meta-analysis
title_short Efficacy and acceptability of lurasidone for bipolar depression: a systematic review and dose–response meta-analysis
title_sort efficacy and acceptability of lurasidone for bipolar depression a systematic review and dose response meta analysis
url https://mentalhealth.bmj.com/content/27/1/e301165.full
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