Abstract: We included seven trials with a total of 239 participants. Two trials were of cross-over design, and outcome data were not available from the first phase (precross-over) in an appropriate format for inclusion as a parallel randomised controlled trial (RCT). Thus, the results of the review are based on five trials with 213 participants. Treatment effects were observed on the following primary endpoints of emotionalism: There is very low quality of evidence from one small RCT that antidepressants increased the number of people who had 50% reduction in emotionalism (RR 16.50, 95% CI 1.07 to 253.40; 19 participants) and low quality evidence from one RCT of improved scores on Center for Neurologic Study - Lability Scale (CNS-LS) and Clinician Interview-Based Impression of Change (CIBIC) with antidepressants (RR 1.44, 95% CI 0.95 to 2.19; 28 participants). There was moderate quality evidence from three RCTS that they increased the number of people who had a reduction in tearfulness (RR 2.18, 95% CI 1.29 to 3.71; 164 participants); and low quality evidence from one RCT of improved scores on the Pathological Laughter and Crying Scale (PLCS) (MD 8.40, 95% CI 11.56 to 5.24; 28 participants). Six trials reported adverse events (death) and found no difference between the groups in death (RR 0.59, 95% CI 0.08 to 4.50; 6 RCTs, 172 participants, moderate-quality evidence). Antidepressants may reduce the frequency and severity of crying or laughing episodes based on very low quality evidence. Our conclusions must be qualified by several methodological deficiencies in the studies and interpreted with caution despite the effect being very large. The effect does not seem specific to one drug or class of drugs. More reliable data are required before appropriate conclusions can be made about the treatment of post-stroke emotionalism. Future trialists investigating the effect of antidepressants in people with emotionalism after stroke should consider developing and using a standardised method to diagnose emotionalism, determine severity and assess change over time; provide treatment for a sufficient duration and follow-up to better assess rates of relapse or maintenance and include careful assessment and complete reporting of adverse events.

Plain-language summary: We included seven randomised controlled trials involving 239 participants in the review, which reported on the use of antidepressants for treating emotionalism. Trials ranged from small (10 participants) to large (92 participants). Mean/median age of participants ranged from 57.8 years to 73 years. Studies were from Europe (UK: 1, Denmark: 1, Scotland: 1, and Sweden: 1); Asia (South Korea: 1; and Japan: 1); and the USA: 1. We included seven trials involving 239 participants (we identified no new trials since the previous version of the review). Two trials were of cross-over design, and outcome data were not available from the first phase (precross-over) in an appropriate format for inclusion as a parallel randomised controlled trial (RCT). Data were only available for five trials with 213 participants. We observed treatment effects on the following: 50% reduction in emotionalism, improvements (reduction) in lability, Clinician Interview-Based Impression of Change (CIBIC), diminished tearfulness and scores on the Pathological Laughter and Crying Scale (PLCS). However, confidence intervals were wide indicating that treatment may have had only a small positive effect, or even a small negative effect (in one trial). Six trials reported death as an adverse event and found no differences between groups. We rated the evidence from very low to moderate quality due to these being small trials with some degree of bias. Antidepressant drugs appear to reduce outbursts of crying or laughing. More trials with systematic assessment and reporting of adverse events are needed to ensure that these benefits outweigh the risks.