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Review
. 2023 Mar 31;3(3):CD011006.
doi: 10.1002/14651858.CD011006.pub4.

Antidepressants for the treatment of depression in people with cancer

Giovanni Vita  1 , Beatrice Compri  1 , Faith Matcham  2 , Corrado Barbui  3 , Giovanni Ostuzzi  3
Affiliations
Review

Antidepressants for the treatment of depression in people with cancer

Giovanni Vita et al. Cochrane Database Syst Rev. .

Abstract

Background: Major depression and other depressive conditions are common in people with cancer. These conditions are not easily detectable in clinical practice, due to the overlap between medical and psychiatric symptoms, as described by diagnostic manuals such as the Diagnostic and Statistical Manual of Mental Disorders (DSM) and International Classification of Diseases (ICD). Moreover, it is particularly challenging to distinguish between pathological and normal reactions to such a severe illness. Depressive symptoms, even in subthreshold manifestations, have a negative impact in terms of quality of life, compliance with anticancer treatment, suicide risk and possibly the mortality rate for the cancer itself. Randomised controlled trials (RCTs) on the efficacy, tolerability and acceptability of antidepressants in this population are few and often report conflicting results.

Objectives: To evaluate the efficacy, tolerability and acceptability of antidepressants for treating depressive symptoms in adults (aged 18 years or older) with cancer (any site and stage).

Search methods: We used standard, extensive Cochrane search methods. The latest search date was November 2022.

Selection criteria: We included RCTs comparing antidepressants versus placebo, or antidepressants versus other antidepressants, in adults (aged 18 years or above) with any primary diagnosis of cancer and depression (including major depressive disorder, adjustment disorder, dysthymic disorder or depressive symptoms in the absence of a formal diagnosis).

Data collection and analysis: We used standard Cochrane methods. Our primary outcome was 1. efficacy as a continuous outcome. Our secondary outcomes were 2. efficacy as a dichotomous outcome, 3. Social adjustment, 4. health-related quality of life and 5. dropouts. We used GRADE to assess certainty of evidence for each outcome.

Main results: We identified 14 studies (1364 participants), 10 of which contributed to the meta-analysis for the primary outcome. Six of these compared antidepressants and placebo, three compared two antidepressants, and one three-armed study compared two antidepressants and placebo. In this update, we included four additional studies, three of which contributed data for the primary outcome. For acute-phase treatment response (six to 12 weeks), antidepressants may reduce depressive symptoms when compared with placebo, even though the evidence is very uncertain. This was true when depressive symptoms were measured as a continuous outcome (standardised mean difference (SMD) -0.52, 95% confidence interval (CI) -0.92 to -0.12; 7 studies, 511 participants; very low-certainty evidence) and when measured as a proportion of people who had depression at the end of the study (risk ratio (RR) 0.74, 95% CI 0.57 to 0.96; 5 studies, 662 participants; very low-certainty evidence). No studies reported data on follow-up response (more than 12 weeks). In head-to-head comparisons, we retrieved data for selective serotonin reuptake inhibitors (SSRIs) versus tricyclic antidepressants (TCAs) and for mirtazapine versus TCAs. There was no difference between the various classes of antidepressants (continuous outcome: SSRI versus TCA: SMD -0.08, 95% CI -0.34 to 0.18; 3 studies, 237 participants; very low-certainty evidence; mirtazapine versus TCA: SMD -4.80, 95% CI -9.70 to 0.10; 1 study, 25 participants). There was a potential beneficial effect of antidepressants versus placebo for the secondary efficacy outcomes (continuous outcome, response at one to four weeks; very low-certainty evidence). There were no differences for these outcomes when comparing two different classes of antidepressants, even though the evidence was very uncertain. In terms of dropouts due to any cause, we found no difference between antidepressants compared with placebo (RR 0.85, 95% CI 0.52 to 1.38; 9 studies, 889 participants; very low-certainty evidence), and between SSRIs and TCAs (RR 0.83, 95% CI 0.53 to 1.22; 3 studies, 237 participants). We downgraded the certainty of the evidence because of the heterogeneous quality of the studies, imprecision arising from small sample sizes and wide CIs, and inconsistency due to statistical or clinical heterogeneity.

Authors' conclusions: Despite the impact of depression on people with cancer, the available studies were few and of low quality. This review found a potential beneficial effect of antidepressants against placebo in depressed participants with cancer. However, the certainty of evidence is very low and, on the basis of these results, it is difficult to draw clear implications for practice. The use of antidepressants in people with cancer should be considered on an individual basis and, considering the lack of head-to-head data, the choice of which drug to prescribe may be based on the data on antidepressant efficacy in the general population of people with major depression, also taking into account that data on people with other serious medical conditions suggest a positive safety profile for the SSRIs. Furthermore, this update shows that the usage of the newly US Food and Drug Administration-approved antidepressant esketamine in its intravenous formulation might represent a potential treatment for this specific population of people, since it can be used both as an anaesthetic and an antidepressant. However, data are too inconclusive and further studies are needed. We conclude that to better inform clinical practice, there is an urgent need for large, simple, randomised, pragmatic trials comparing commonly used antidepressants versus placebo in people with cancer who have depressive symptoms, with or without a formal diagnosis of a depressive disorder.

Trial registration: ClinicalTrials.gov NCT00935675 NCT02246244 NCT00005805 NCT00129467 NCT00234195 NCT00352885 NCT00488072 NCT00536172 NCT00832520 NCT01219673 NCT01501396 NCT01725048.

PubMed Disclaimer

Conflict of interest statement

GV: none.

BC: none.

FM: none.

CB: none.

GO: none.

Figures

1
1
PRISMA flow diagram.
2
2
Forest plot of comparison: 1 Depression: efficacy at six to 12 weeks (continuous outcome), outcome: 1.1 Antidepressants versus placebo.
3
3
Forest plot of comparison: 1 Depression: efficacy at six to 12 weeks (continuous outcome), outcome: 1.2 Antidepressants versus antidepressants.
1.1
1.1. Analysis
Comparison 1: Depression: efficacy as a continuous outcome at 6–12 weeks, Outcome 1: Antidepressants vs placebo
1.2
1.2. Analysis
Comparison 1: Depression: efficacy as a continuous outcome at 6–12 weeks, Outcome 2: SSRIs vs TCAs
1.3
1.3. Analysis
Comparison 1: Depression: efficacy as a continuous outcome at 6–12 weeks, Outcome 3: Mirtazapine vs TCA
2.1
2.1. Analysis
Comparison 2: Depression: efficacy as a continuous outcome at 1–4 weeks, Outcome 1: Antidepressants vs placebo
2.2
2.2. Analysis
Comparison 2: Depression: efficacy as a continuous outcome at 1–4 weeks, Outcome 2: Mirtazapine vs TCA
3.1
3.1. Analysis
Comparison 3: Depression: efficacy as a dichotomous outcome at 6–12 weeks, Outcome 1: Antidepressants vs placebo
3.2
3.2. Analysis
Comparison 3: Depression: efficacy as a dichotomous outcome at 6–12 weeks, Outcome 2: SSRI vs TCA
3.3
3.3. Analysis
Comparison 3: Depression: efficacy as a dichotomous outcome at 6–12 weeks, Outcome 3: Mirtazapine vs TCA
4.1
4.1. Analysis
Comparison 4: Social adjustment at 6–12 weeks, Outcome 1: Antidepressants vs antidepressants
5.1
5.1. Analysis
Comparison 5: Quality of life at 6–12 weeks, Outcome 1: Antidepressants vs placebo
5.2
5.2. Analysis
Comparison 5: Quality of life at 6–12 weeks, Outcome 2: Antidepressants vs antidepressants
6.1
6.1. Analysis
Comparison 6: Dropouts due to any cause (acceptability), Outcome 1: Antidepressants vs placebo
6.2
6.2. Analysis
Comparison 6: Dropouts due to any cause (acceptability), Outcome 2: SSRI vs TCA
6.3
6.3. Analysis
Comparison 6: Dropouts due to any cause (acceptability), Outcome 3: Mirtazapine vs TCA
7.1
7.1. Analysis
Comparison 7: Dropouts due to inefficacy, Outcome 1: Antidepressants vs placebo
7.2
7.2. Analysis
Comparison 7: Dropouts due to inefficacy, Outcome 2: Antidepressants vs antidepressants
8.1
8.1. Analysis
Comparison 8: Dropouts due to adverse effects (tolerability), Outcome 1: Antidepressants vs placebo
8.2
8.2. Analysis
Comparison 8: Dropouts due to adverse effects (tolerability), Outcome 2: Antidepressants vs antidepressants
9.1
9.1. Analysis
Comparison 9: Subgroup analysis: psychiatric diagnosis, Outcome 1: Antidepressants vs placebo
9.2
9.2. Analysis
Comparison 9: Subgroup analysis: psychiatric diagnosis, Outcome 2: SSRI vs TCA
9.3
9.3. Analysis
Comparison 9: Subgroup analysis: psychiatric diagnosis, Outcome 3: Mirtazapine vs TCA
10.1
10.1. Analysis
Comparison 10: Subgroup analysis: cancer site, Outcome 1: Antidepressants vs placebo
10.2
10.2. Analysis
Comparison 10: Subgroup analysis: cancer site, Outcome 2: Antidepressants vs antidepressants
11.1
11.1. Analysis
Comparison 11: Subgroup analysis: cancer stage, Outcome 1: Antidepressants vs placebo
11.2
11.2. Analysis
Comparison 11: Subgroup analysis: cancer stage, Outcome 2: Antidepressants vs antidepressants
12.1
12.1. Analysis
Comparison 12: Sensitivity analysis: excluding trials that did not employ depressive symptoms as their primary outcome, Outcome 1: Antidepressants vs placebo
13.1
13.1. Analysis
Comparison 13: Sensitivity analysis: excluding trials with imputed data, Outcome 1: Antidepressants vs placebo
13.2
13.2. Analysis
Comparison 13: Sensitivity analysis: excluding trials with imputed data, Outcome 2: Mirtazapine vs TCA
See this image and copyright information in PMC

Update of

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NCT00129467 {unpublished data only}
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NCT00234195 {unpublished data only}
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NCT00302744 {published data only}
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NCT00352885 {unpublished data only}
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NCT00488072 {unpublished data only}
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NCT00536172 {unpublished data only}
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NCT00832520 {unpublished data only}
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NCT01598584 {unpublished data only}
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NCT01719861 {published data only}
    1. NCT01719861. Phase 2a desipramine in small cell lung cancer and other high-grade neuroendocrine tumors. clinicaltrials.gov/ct2/show/NCT01719861 (first received 1 November 2012). [NCT01719861]
NCT01725048 {unpublished data only}
    1. NCT01725048. Pilot study to evaluate individualized choice of antidepressants in patients with cancer. clinicaltrials.gov/ct2/show/NCT01725048 (first received 12 November 2012).
NCT02443194 {published data only}
    1. NCT02443194. The effect of duloxetine on mood, quality of life and cognitive functioning in glioblastoma patients. clinicaltrials.gov/ct2/show/NCT02443194 (first received 13 May 2015). [NCT02443194]
NCT02637466 {published data only}
    1. NCT02637466. Vortioxetine for MDD, cognition, and systemic inflammatory biomarkers. clinicaltrials.gov/ct2/show/NCT02637466 (first received 22 December 2015). [CLINICALTRIALS.GOV: NCT02637466]
NCT02650544 {published data only}
    1. NCT02650544. Efficacy and safety analyses of mirtazapine in NSCLC patients with depression. clinicaltrials.gov/ct2/show/NCT02650544 (first received 8 January 2016). [NCT02650544]
NCT03086148 {published data only}
    1. NCT03086148. Ketamine and postoperative depressive symptom. clinicaltrials.gov/ct2/show/NCT03086148 (first received 22 March 2017). [NCT03086148]
NCT03254173 {published data only}
    1. NCT03254173. Mirtazapine for treatment of cancer associated anorexia-cachexia (MCACS100). clinicaltrials.gov/ct2/show/NCT03254173 (first received 18 August 2017). [CLINICALTRIALS.GOV: NCT03254173]
NCT03935685 {published data only}
    1. NCT03935685. Pilot study of mirtazapine for the dual Tx of depression and CINV in high-grade glioma Pts on TMZ. clinicaltrials.gov/ct2/show/NCT03935685 (first received 2 May 2019). [CLINICALTRIALS.GOV: NCT03935685]
NCT03996265 {published data only}
    1. NCT03996265. Bupropion in Reducing Cancer Related Fatigue in Stage I-III Breast Cancer Survivors. clinicaltrials.gov/ct2/show/NCT03996265 (first received 24 June 2019). [CLINICALTRIALS.GOV: NCT03996265]
NCT04253678 {published data only}
    1. NCT04253678. Vortioxetine for Cancer Patients With Depression: An Observational Study. clinicaltrials.gov/ct2/show/NCT04253678 (first received 5 February 2020). [CLINICALTRIALS.GOV: 04253678]
Ng 2014 {published data only}
    1. Ng CG, Boks MP, Roes KC, Zainal NZ, Sulaiman AH, Tan SB, et al. Rapid response to methylphenidate as an add-on therapy to mirtazapine in the treatment of major depressive disorder in terminally ill cancer patients: a four-week, randomized, double-blinded, placebo-controlled study. European Neuropsychopharmacology 2014;24:491-8. [DOI: 10.1016/j.euroneuro.2014.01.016] - DOI - PubMed
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    1. Nunez GR, Pinczowski H, Zanellato R, Tateyama L, Schindler F, Fonseca F, et al. Bupropion for control of hot flashes in breast cancer survivors: a prospective, double-blind, randomized, crossover, pilot phase II trial. Journal of Pain and Symptom Management 2013;45(6):969-79. [DOI: 10.1016/j.jpainsymman.2012.06.011] - DOI - PubMed
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    1. Palesh OG, Mustian KM, Peppone LJ, Janelsins M, Sprod LK, Kesler S, et al. Impact of paroxetine on sleep problems in 426 cancer patients receiving chemotherapy: a trial from the University of Rochester Cancer Center Community Clinical Oncology Program. Sleep Medicine 2012;13(9):1184-90. [DOI: 10.1016/j.sleep.2012.06.001] - DOI - PMC - PubMed
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Panwar 2018 {published data only}
    1. Panwar A, Rieke K, Burke WJ, Sayles H, Lydiatt WM. Prevention of Depression in Patients Being Treated for Head and Neck Cancer Trial (PROTECT) study group. Identification of baseline characteristics associated with development of depression among patients with head and neck cancer: a secondary analysis of a randomized clinical trial. JAMA Otolaryngology – Head & Neck Surgery 2018;1(11):1004-10. [DOI: 10.1001/jamaoto.2018.2228] - DOI - PMC - PubMed
Peng 2021 {published data only}
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    1. Roscoe JA, Morrow GR, Hickok JT, Mustian KM, Griggs JJ, Matteson SE, et al. Effect of paroxetine hydrochloride (Paxilò) on fatigue and depression in breast cancer patients receiving chemotherapy. Breast Cancer Research and Treatment 2005;89(3):243-9. [PMID: ] - PubMed
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Ross 2021 {published data only}
    1. Ross S, Agin-Liebes G, Lo S, Zeifman RJ, Ghazal L, Benville J, et al. Acute and sustained reductions in loss of meaning and suicidal ideation following psilocybin-assisted psychotherapy for psychiatric and existential distress in life-threatening cancer. ACS Pharmacology & Translational Science 2021;4(2):553-62. [DOI: 10.1021/acsptsci.1c00020.] - DOI - PMC - PubMed
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    1. Sullivan DR, Mongoue-Tchokote S, Mori M, Goy E, Ganzini L. Randomized, double-blind, placebo-controlled study of methylphenidate for the treatment of depression in SSRI-treated cancer patients receiving palliative care. Psychooncology 2017;26(11):1763-9. [PMID: doi: 10.1002/pon.4220. Epub 2016 Aug 12. PMID: 27429350; PMCID: PMC5509522.] - PMC - PubMed
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Theobald 2002 {published data only}
    1. Theobald DE, Kirsh KL, Holtsclaw E, Donaghy K, Passik SD. An open-label, crossover trial of mirtazapine (15 and 30 mg) in cancer patients with pain and other distressing symptoms. Journal of Pain and Symptom Management 2002;23(5):442-7. [PMID: ] - PubMed
Tondlova 1997 {published data only}
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Tondlova 2002 {published data only}
    1. Tondlová H, Baštecký J. Citalopram and dosulepine in adjuvant treatment of oncological pain [Citalopram a dosulepin v adjuv antním léčení nádorové bolesti]. Bolest 2002;4:0.
UKCCCR {unpublished data only}
    1. UK Co-ordinating Committee on Cancer Research (UKCCCR). Neuropathic Pain Trial I: a national randomised trial of amitriptyline versus placebo. controlled-trials.com 2007. [PA/NPS]
Vitolins 2013 {published data only}
    1. Vitolins MZ, Griffin L, Tomlinson WV, Vuky J, Adams PT, Moose D, et al. Randomized trial to assess the impact of venlafaxine and soy protein on hot flashes and quality of life in men with prostate cancer. Journal of Clinical Oncology 2013;31(32):4092-8. - PMC - PubMed
Zhang 2003 {published data only}
    1. Zhang L. Paroxetine in treatment of cancer patients with anxiety and depression. Zhongguo zin li wei sheng za zhi (Chinese Mental Health Journal) 2003;17(7):482-3. [ETOCRN134568493]
Zhang 2011 {published data only}
    1. Zhang J, Fang F, Zhang C. Preliminary study of association between breast cancer and depression [乳腺癌与抑郁相关性的初步研究]. Tumor 2011;31(5):457-9. [DOI: 10.3781/j.issn.1000-7431.2011.05.015] - DOI
Zimmerman 2016 {published data only}
    1. Zimmerman C, Atherton PJ, Pachman D, Seisler D, Wagner-Johnston N, Dakhil S, et al. MC11C4: a pilot randomized, placebo-controlled, double-blind study of venlafaxine to prevent oxaliplatin-induced neuropathy. Supportive Care in Cancer 2016;24(3):1071-8. - PMC - PubMed
Zvukova 2010 {published data only}
    1. Zvukova EM, Mokhov EM, Marasanov SB. Pharmacological correction of psychoemotional states of patients with thyroid nodules in the preoperative period [ФАРМАКОЛОГИЧЕСКАЯ КОРРЕКЦИЯ ПСИХОЭМОЦИОНАЛЬНОГОСТАТУСА БОЛЬНЫХ С УЗЛОВЫМИ ОБРАЗОВАНИЯМИЩИТОВИДНОЙ ЖЕЛЕЗЫ В ПРЕДОПЕРАЦИОННОМ ПЕРИОДЕГоУ ВПО Тверская государственная медицинская академия]. Russian Journal of Medicine 2011;3c(6):31-3.

References to studies awaiting assessment

N0405078066 {unpublished data only}
    1. N0405078066. Randomised double-blind placebo controlled trial of venlafaxine in recently diagnosed lung cancer patients: effects on symptom profiles after 12 weeks. controlled-trials.com 2003. [N0405078066]
UMIN000008768 {unpublished data only}
    1. UMIN000008768. A randomized comparative study of efficacy and safety between mirtazapine and duloxetine hydrochloride in patients with cancer. UMIN Clinical Trials Registry 2012. [UMIN000008768]

References to ongoing studies

IRCT20210425051075N1 {unpublished data only}
    1. IRCT20220406054440N1. Comparison of the effectiveness of mirtazapine and citalopram on general health and quality of life in patients with major depression and breast cancer in the oncology ward. en.irct.ir/trial/63231 (first received 10 May 2022).
NCT04303325 {published data only}
    1. NCT04303325. Effect of esketamine on postoperative depression, gut microbiota, Bispectral Index data of depression patients undergoing breast cancer operation (ESPOD-BI) (ESPOD-BI). clinicaltrials.gov/ct2/show/record/NCT04303325 (first received 11 March 2020). [CLINICALTRIALS.GOV: NCT04303325]
NCT04763135 {published data only}
    1. NCT04763135. Mirtazapine in cancer-related poly-symptomatology (MIR-P). clinicaltrials.gov/ct2/show/record/NCT04763135 (first received 21 February 2021). [CLINICALTRIALS.GOV: NCT04763135]
NCT04818099 {published data only}
    1. NCT04818099. Vortioxetine in the treatment of depression associated with head and neck cancers undergoing radiotherapy. clinicaltrials.gov/ct2/show/record/NCT04818099 (first received 26 March 2021). [CLINICALTRIALS.GOV: NCT04818099]

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References to other published versions of this review

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