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Meta-Analysis
. 2020 Jan 28;1(1):CD003437.
doi: 10.1002/14651858.CD003437.pub4.

Pharmacological, psychological, and non-invasive brain stimulation interventions for treating depression after stroke

Sabine Allida  1 , Katherine Laura Cox  1 , Cheng-Fang Hsieh  2 , Helen Lang  3 , Allan House  4 , Maree L Hackett  1   5
Affiliations
Meta-Analysis

Pharmacological, psychological, and non-invasive brain stimulation interventions for treating depression after stroke

Sabine Allida et al. Cochrane Database Syst Rev. .

Update in

Abstract

Background: Depression is an important morbidity associated with stroke that impacts on recovery yet often undetected or inadequately treated. This is an update and expansion of a Cochrane Review first published in 2004 and updated in 2008.

Objectives: Primary objective • To determine whether pharmacological therapy, non-invasive brain stimulation, psychological therapy, or combinations of these interventions reduce the prevalence of diagnosable depression after stroke Secondary objectives • To determine whether pharmacological therapy, non-invasive brain stimulation, psychological therapy, or combinations of these interventions reduce levels of depressive symptoms, improve physical and neurological function and health-related quality of life, and reduce dependency after stroke • To assess the safety of and adherence to such treatments SEARCH METHODS: We searched the Specialised Registers of Cochrane Stroke and Cochrane Depression Anxiety and Neurosis (last searched August 2018), the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 1), in the Cochrane Library, MEDLINE (1966 to August 2018), Embase (1980 to August 2018), the Cumulative Index to Nursing and Alllied Health Literature (CINAHL) (1982 to August 2018), PsycINFO (1967 to August 2018), and Web of Science (2002 to August 2018). We also searched reference lists, clinical trial registers (World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) to August 2018; ClinicalTrials.gov to August 2018), and conference proceedings, and we contacted study authors.

Selection criteria: Randomised controlled trials comparing (1) pharmacological interventions with placebo; (2) one of various forms of non-invasive brain stimulation with sham stimulation or usual care; (3) one of various forms of psychological therapy with usual care and/or attention control; (4) pharmacological intervention and various forms of psychological therapy with pharmacological intervention and usual care and/or attention control; (5) non-invasive brain stimulation and pharmacological intervention with pharmacological intervention and sham stimulation or usual care; (6) pharmacological intervention and one of various forms of psychological therapy with placebo and psychological therapy; (7) pharmacological intervention and non-invasive brain stimulation with placebo plus non-invasive brain stimulation; (8) non-invasive brain stimulation and one of various forms of psychological therapy versus non-invasive brain stimulation plus usual care and/or attention control; and (9) non-invasive brain stimulation and one of various forms of psychological therapy versus sham brain stimulation or usual care plus psychological therapy, with the intention of treating depression after stroke.

Data collection and analysis: Two review authors independently selected studies, assessed risk of bias, and extracted data from all included studies. We calculated mean difference (MD) or standardised mean difference (SMD) for continuous data, and risk ratio (RR) for dichotomous data, with 95% confidence intervals (CIs). We assessed heterogeneity using the I² statistic and certainty of the evidence according to GRADE.

Main results: We included 49 trials (56 comparisons) with 3342 participants. Data were available for: (1) pharmacological interventions with placebo (with 20 pharmacological comparisons); (2) one of various forms of non-invasive brain stimulation with sham stimulation or usual care (with eight non-invasive brain stimulation comparisons); (3) one of various forms of psychological therapy with usual care and/or attention control (with 16 psychological therapy comparisons); (4) pharmacological intervention and various forms of psychological therapy with pharmacological intervention and usual care and/or attention control (with two comparisons); and (5) non-invasive brain stimulation and pharmacological intervention with pharmacological intervention and sham stimulation or usual care (with 10 comparisons). We found no trials for the following comparisons: (6) pharmacological intervention and various forms of psychological therapy interventions versus placebo and psychological therapy; (7) pharmacological intervention and non-invasive brain stimulation versus placebo plus non-invasive brain stimulation; (8) non-invasive brain stimulation and one of various forms of psychological therapy versus non-invasive brain stimulation plus usual care and/or attention control; and (9) non-invasive brain stimulation and one of various forms of psychological therapy versus sham brain stimulation or usual care plus psychological therapy. Treatment effects observed: very low-certainty evidence from eight trials suggests that pharmacological interventions decreased the number of people meeting study criteria for depression (RR 0.70, 95% CI 0.55 to 0.88; 1025 participants) at end of treatment, and very low-certainty evidence from six trials suggests that pharmacological interventions decreased the number of people with less than 50% reduction in depression scale scores at end of treatment (RR 0.47, 95% CI 0.32 to 0.69; 511 participants) compared to placebo. No trials of non-invasive brain stimulation reported on meeting study criteria for depression at end of treatment. Only one trial of non-invasive brain stimulation reported on the outcome <50% reduction in depression scale scores; thus, we were unable to perform a meta-analysis for this outcome. Very low-certainty evidence from six trials suggests that psychological therapy decreased the number of people meeting the study criteria for depression at end of treatment (RR 0.77, 95% CI 0.62 to 0.95; 521 participants) compared to usual care/attention control. No trials of combination therapies reported on the number of people meeting the study criteria for depression at end of treatment. Only one trial of combination (non-invasive brain stimulation and pharmacological intervention) therapy reported <50% reduction in depression scale scores at end of treatment. Thus, we were unable to perform a meta-analysis for this outcome. Five trials reported adverse events related to the central nervous system (CNS) and noted significant harm in the pharmacological interventions group (RR 1.55, 95% CI 1.12 to 2.15; 488 participants; very low-certainty evidence). Four trials found significant gastrointestinal adverse events in the pharmacological interventions group (RR 1.62, 95% CI 1.19 to 2.19; 473 participants; very low-certainty evidence) compared to the placebo group. No significant deaths or adverse events were found in the psychological therapy group compared to the usual care/attention control group. Non-invasive brain stimulation interventions and combination therapies resulted in no deaths.

Authors' conclusions: Very low-certainty evidence suggests that pharmacological or psychological therapies can reduce the prevalence of depression. This very low-certainty evidence suggests that pharmacological therapy, psychological therapy, non-invasive brain stimulation, and combined interventions can reduce depressive symptoms. Pharmacological intervention was associated with adverse events related to the CNS and the gastrointestinal tract. More research is required before recommendations can be made about the routine use of such treatments.

PubMed Disclaimer

Conflict of interest statement

SA: none known. KC: none known. C‐FH: none known. HL: none known. AH: none known. MH: none known.

Figures

1
1
Study flow diagram. Eligibility criteria were changed to include non‐invasive brain stimulation interventions in this update. The 2015 search was rerun from the point of inception to screen for non‐invasive brain stimulation and combination interventions.
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
4
4
Funnel plot of comparison: 1 Pharmacological interventions versus placebo, outcome: 1.1 Depression: meeting study criteria for depression at end of treatment.
See this image and copyright information in PMC

Update of

References

References to studies included in this review

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    1. Choi‐Kwon S, Choi J, Kwon SU, Kang D, Kim JS. Fluoxetine is not effective in the treatment of poststroke fatigue: a double‐blind, placebo controlled study. Cerebrovascular Diseases 2007;23:103‐8. - PubMed
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Clark 2003 {published data only}
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Delbari 2011 {published data only}
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Downes 1995 {published data only}
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Evans 1997 {published data only}
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Finkenzeller 2006 {published data only}
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Hadidi 2014 {published data only}
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Hu 2003 {published data only}
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ISRCTN88489864 {published data only}
    1. ISRCTN88489864. Influence of a single dose of fluoxetine on muscle activation patterns and functional ability in chronic stroke patients. http://www.isrctn.com/ISRCTN88489864 (first received 23 July 2005).
Jiang 2004 {published data only}
    1. Jiang JB, Li GC. Effects of post‐stroke depression and anti‐depression therapy on rehabilitation of neurological function in patients with meta method. Chinese Journal of Clinical Rehabilitation 2004;8(31):6829‐31.
Jorge 2004 {published data only}
    1. Jorge RE, Robinson RG, Tateno A, Narushima K, Acion L, Moser D, et al. Repetitive transcranial magnetic stimulation as treatment of poststroke depression: a preliminary study. Biological Psychiatry 2004;55:398‐405. - PubMed
Jorge 2008 {published data only}
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Kim 2010a {published data only}
    1. Kim BR, Kim D, Chun MH, Yi JH, Kwon JS. Effect of repetitive transcranial magnetic stimulation on cognition and mood in stroke patients: a double‐blind, sham‐controlled trial. American Journal of Physical Medicine and Rehabilitation 2010;89(5):362‐8. - PubMed
Kim 2010b {published data only}
    1. Kim BR, Kim D, Chun MH, Yi JH, Kwon JS. Effect of repetitive transcranial magnetic stimulation on cognition and mood in stroke patients: a double‐blind, sham‐controlled trial. American Journal of Physical Medicine and Rehabilitation 2010;89(5):362‐8. - PubMed
Kim 2017 {published data only}
    1. Kim JS, Lee E‐J, Chang D, Park J‐H, Ahn SH, Cha J‐K, et al. Efficacy of early administration of escitalopram on depressive and emotional symptoms and neurological dysfunction after stroke: a multicentre, double‐blind,randomised, placebo‐controlled study. Lancet Psychiatry 2017;4(1):33‐43. - PubMed
Kim 2017a {published data only}
    1. Kim K‐U, Kim S‐H, An T‐G. The effects of repetitive transcranial magnetic stimulation (rTMS) on depression, visual perception, and activities of daily living in stroke patients. Journal of Physical Therapy Science 2017;29:1036–9. - PMC - PubMed
Kootker 2012 {published data only}
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Laska 2005 {published data only}
    1. Laska AC, Arbin M, Kahan T, Hellblom A, Murray V. Long‐term antidepressant treatment with moclobemide for aphasia in acute stroke patients: a randomised, double‐blind, placebo‐controlled study. Cerebrovascular Diseases 2005;19(2):125‐32. - PubMed
Leijon 1989 {published data only}
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Lobjanidze 2010 {published data only}
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Mauri 1988 {published data only}
    1. Marui L, Arboix A, Marti‐Vilalta JL. Efficacy of antidepressive treatment in affective disorders associated to ischemic vascular disease. Neurologia 1988;3 Suppl 3:10.
Meara 1998 {published data only}
    1. Meara JR. A randomised double blind placebo controlled study of the treatment of post stroke depression. National Research Register.
    1. Meara RJ, Thalanany M, Balonwu V, Hobson P. The treatment of depression after stroke with the selective serotonin reuptake inhibitor sertraline. Cerebrovascular Diseases 1998;8 Suppl 4:90.
Narushima 2007 {published data only}
    1. Narushima K, Paradiso S, Moser D, Jorge R, Robinson R. Effect of antidepressant therapy on executive function after stroke. British Journal of Psychiatry 2007;190:260‐5. - PubMed
Ohtomo 1985 {published data only}
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Ostwald 2014 {published data only}
    1. NCT00178529. Intervention for stroke survivors and their spousal caregivers. https://clinicaltrials.gov/ct2/show/NCT00178529 (first received 19 July 2001).
    1. Ostwald S, Godwin K, Cron S, Kelley C, Hersch G, Davis S. Home‐based psychoeducational and mailed information programs for stroke‐caregiving dyads post‐discharge: a randomized trial. Disability and Rehabilitation 2014;36(1):55‐62. - PubMed
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Otomo 1986 {published data only}
    1. Otomo E, Tohgi H, Hirai S, Gotoh F, Hasegawa K, Tazaki Y, et al. Clinical evaluation of YM‐08054 (indeloxazine) in the treatment of cerebrovascular disorder. Igaku no Ayumi 1986;136(7):535‐55.
Raffaele 1996 {published data only}
    1. Raffaele R, Rampello L, Vecchio I, Tornali C, Malaguanera M. Trazodone therapy of the post‐stroke depression. Archives of Gerontology and Geriatrics 1996;22 Suppl 1:217‐20. - PubMed
Rich 2016 {published data only}
    1. Rich TL, Menk J, Krach LE, Feyma T, Gillick BT. Repetitive transcranial magnetic stimulation/behavioural intervention clinical trial: long‐term follow‐up of outcomes in congenital hemiparesis. Journal of Child and Adolescent Psychopharmacology 2016;26(7):598‐605. - PMC - PubMed
Robinson 2000 {published data only}
    1. Robinson RG, Schultz SK, Castillo C, Kopel T, Kosier T, Newman M, et al. Nortriptyline versus fluoxetine in the treatment of depression and in‐short‐term recovery after stroke: a placebo‐controlled, double‐blind study. American Journal of Psychiatry 2000;157(3):351‐9. - PubMed
Robinson 2017 {published data only}
    1. Robinson RG, Jorge RE, Long J. Prevention of poststroke mortality using problem‐solving therapy or escitalopram. American Journal of Geriatric Psychiatry 2017;25(5):512‐9. - PubMed
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Sieger 2018 {published data only}
    1. Sieger FS, Poveda MYP, Moreno AP, Sanchez JAM, Romero LAL, Guzman LCR, et al. Effects of repetitive transcranial magnetic stimulation in aphasic stroke: a randomised double‐blind controlled clinical trial. Neurology 2018;90(15 Suppl 1):P5.004.
Sivenius 2001 {published data only}
    1. Sivenius J, Sarasoja T, Aaltonen H, Heinonen E, Kilkku O, Reinikainen K. Selegiline treatment facilitates recovery after stroke. Journal of Neurologic Rehabilitation 2001;15(3):183‐90. - PubMed
Su 2004a {published data only}
    1. Su XL, Xiao XC. Effect of psychotherapy on the motor functional rehabilitation in patients with post‐stroke depression. Chinese Journal of Clinical Rehabilitation 2004;8(19):3720‐1.
Sun 2000 {published data only}
    1. Sun B, Chan JL. Effects of psychological rehabilitation on the recovery of hemiplegia patients after stroke. Modern Rehabilitation 2000;4(1):36‐7.
Szepfalusi 2017 {published data only}
    1. Szepfalusi N, Nemeth VL, Vekony T, Imre N, Balogh R, Holczer A, et al. Ten‐day cognitive training program combined with transcranial direct current stimulation (tDCS) in stroke rehabilitation ‐ a sham controlled study. European Neuropsychopharmacology 2017;27 Suppl 4:S1038‐9.
    1. Szepfalusi N, Nemeth VL, Vekony T, Imre N, Balogh R, Holczer A, et al. The use of transcranial direct current stimulation (tDCS) combined with cognitive training in stroke rehabilitation ‐ a sham‐controlled pilot study. Cerebrovascular Diseases 2017;43 Suppl 1:61.
Valiengo 2017 {published data only}
    1. NCT01525524. Treatment of major depressive disorder post stroke with transcranial direct current stimulation. https://clinicaltrials.gov/ct2/show/NCT01525524 (first received 3 February 2012).
    1. Valiengo LCL, Goulart AC, Oliveira JF, Benseñor IM, Lotufo PA, Brunoni AR. Transcranial direct current stimulation for the treatment of post‐stroke depression: results from a randomised, sham‐controlled, double‐blinded trial. Journal of Neurology, Neurosurgery and Psychiatry 2017;88:170‐5. - PubMed
Visser 2015 {published data only}
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Wang 2009 {published data only}
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References to studies awaiting assessment

Chen 2002a {published data only}
    1. Chen W, Wang GF, Chen XH, Sheng YL, Zhu H. Effects of paroxetine on function recovery in patients with poststroke depression. Chinese Journal of Clinical Rehabilitation 2002;6(13):2014‐5.
Chen 2002b {published data only}
    1. Chen W, Wang GF, Chen XH, Sheng YL, Zhu H. Effects of paroxetine on function recovery in patients with poststroke depression. Chinese Journal of Clinical Rehabilitation 2002;6(13):2014‐5.
Ding 2005 {published data only}
    1. Ding D, Zhang Z. Combination of paroxetine and psychotherapy in the treatment of post‐stroke depression. Shanghai Archives of Psychiatry 2005;17(2):89‐91.
Evans 1985 {published data only}
    1. Evans RL, Kleinman L, Halar EM, Herzer K. Predicting outcome of group counselling with severely disabled patients. American Journal of Physical Medicine 1985;64(1):24‐31. - PubMed
Finkenzeller 2009 {published data only}
    1. Finkenzeller W, Zobel I, Rietz S, Schramm E, Berger M. Interpersonal psychotherapy and pharmacotherapy in post‐stroke depression [Interpersonelle Psychotherapie und Pharmakotherapie bei Post‐Stroke‐Depression]. Nervenarzt 2009;80:805‐12. - PubMed
Hanspal 2007 {published data only}
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He 2003 {published data only}
    1. He C. The effect of psychological intervention combined with amitriptyline on patients with depression after stroke. Chinese Journal of Clinical Rehabilitation 2003;7(5):850.
He 2005 {published data only}
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    1. He Y. Prospective study of effects of paroxetine with mental intervention on depression and anxiety after stroke. Nervous Disease and Mental Health 2005;5(1):6‐8.
Huang 2005 {published data only}
    1. Huang C, Shi G, Bai C. A comparative study of venlafaxine plus cognitive therapy in the treatment of post‐stroke depression. Chinese Journal of Behavioral Medical Science 2005;14(9):790‐1.
Katz 1998 {published data only}
    1. Katz RA, Hubbard DJ, Blaine J. The effect of group psychotherapy on post‐stroke depression. Rehabilitation Psychology 1998;43(2):178.
Latow 1983 {published data only}
    1. Latow J. Psychotherapy and its effect on depression, sick‐role identification and rehabilitation outcome for stroke victims. Archives of Physical Medicine and Rehabilitation 1983;64(10):511‐2.
Lee 2005 {published data only}
    1. Lee NG, Choi IS, Kim JH, Lee SY, Han JY. The effect of repetitive transcranial magnetic stimulation on the post‐stroke depression. Proceedings of the Proceedings of 3rd World Congress of the International Society of Physical and Rehabilitation Medicine ‐ ISPRM. Brazil, Sao Paulo, 10‐14 April 2005:105‐9.
Liu 2010 {published data only}
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Pearson 2005 {published data only}
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Tang 2002 {published data only}
    1. Tang LY, Ye JH. Cognitive therapy on depression and cognitive dysfunction after stroke. Nursing Journal of Chinese People's Liberation Army 2002;19(4):6‐7.
Wang 2015 {published data only}
    1. Wang J, Zhang M, Xu L. The clinical observation of post‐stroke depression improvement by repetitive transcranial magnetic stimulation. Chinese Journal of Rehabilitation 2015;6(30):167‐70.
Yan 2010a {published data only}
    1. Yan TT, He LM, Gu ZT. A randomized, controlled study of high‐ and low‐frequency rTMS on the treatment outcome for post stroke depression [高频及低频重复经颅磁剌激对脑卒中后抑郁的疗效对比研究]. Qingdao Yiyao Weisheng 2010;42(2):81‐5.
Yan 2010b {published data only}
    1. Yan TT, He LM, Gu ZT. A randomized, controlled study of high‐ and low‐frequency rTMS on the treatment outcome for post stroke depression [高频及低频重复经颅磁剌激对脑卒中后抑郁的疗效对比研究]. Qingdao Yiyao Weisheng 2010;42(2):81‐5.
Yan 2010c {published data only}
    1. Yan TT, He LM, Gu ZT. A randomized, controlled study of high‐ and low‐frequency rTMS on the treatment outcome for post stroke depression [[高频及低频重复经颅磁剌激对脑卒中后抑郁的疗效对比研究]]. Qingdao Yiyao Weisheng 2010;42(2):81‐5.
Yan 2010d {published data only}
    1. Yan TT, He LM, Gu ZT. A randomized, controlled study of high‐ and low‐frequency rTMS on the treatment outcome for post stroke depression [高频及低频重复经颅磁剌激对脑卒中后抑郁的疗效对比研究]. Qingdao Yiyao Weisheng 2010;42(2):81‐5.

References to ongoing studies

Kirkevold 2018 {published data only}
    1. Kirkevold M, Bragstad LK, Bronken BA, Kvigne K, Martinsen R, Hjelle EG, et al. Promoting psychosocial well‐being following stroke: study protocol for a randomized, controlled trial. BMC Psychology 2018;6(12):1‐12. - PMC - PubMed
NCT03056287 {published data only}
    1. NCT03056287. Exercise and brain stimulation for post‐stroke. https://clinicaltrials.gov/ct2/show/NCT03056287 (first received 17 February 2017).
Tang 2017 {published data only}
    1. Tang Y, Chen A, Zhu S, Yang L, Zhou J, Pan S, et al. Repetitive transcranial magnetic stimulation for depression after basal ganglia ischaemic stroke: protocol for a multicentre randomised double‐blind placebo‐controlled trial. BMJ Open 2017;8:1‐7. - PMC - PubMed
Thomas 2016 {published data only}
    1. Thomas SA, Coates E, das Nair R, Lincoln NB, Cooper C, Palmer R, et al. BEhavioural Activation therapy for Depression after Stroke (BEADS): a study protocol for a feasibility randomised controlled pilot trial of a psychological intervention for post‐stroke depression. Pilot and Feasibility Studies 2016;2(45):1‐12. - PMC - PubMed
Xu 2016 {published data only}
    1. Xu SM, Zou DZ, Shen LY, Zhou XY, Pu JC, Dong MX, et al. Efficacy and feasibility of antidepressant treatment in patients with post‐stroke depression. Medicine 2016;95(45):e5349. - PMC - PubMed

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