Study | Adverse events |
Adewuya 2019 |
At 12 months, compared with the stepped care intervention group, the enhanced usual care group reported significantly more deaths (15/451; 3.3% vs 3/456; 0.6%) and more cases of deliberate self‐harm (35/451; 7.8% vs 10/456; 2.2%) |
Gureje 2019 (STEPCARE) | At 12 months, 17 deaths had occurred in the intervention group (total 562) and 16 in the control group (total 473). Deaths were due to hypertension or heart disease in 8 patients, tuberculosis in 6 patients, diabetes in 2 patients, liver failure in 3 patients, typhoid fever in 2 patients, asthma in 2 patients, cancer in 1 patient, and old age or unknown causes in 9 patients. One patient developed psychosis and 1 developed bipolar disorder in the intervention group, and 1 developed bipolar disorder in the control group. Suicidal ideation was reported in 57 participants in the intervention group (10%) and in 66 participants in the control group (14%). All adverse events were deemed not related to study procedures |
Jenkins 2013 | No deaths in either arm No reported mention of suicide attempt |
Indu 2018 | No serious adverse events including new onset of suicidality or bipolar disorder or psychotic features |
Patel 2010 | There were 7 serious adverse events (3 deaths and 4 suicide attempts) in the collaborative stepped care group and 12 in the enhanced usual care group (6 deaths and 6 suicide attempts). None of the deaths were the result of suicide |