使用司替戊醇会引发抑郁自杀行为吗？

Epilepsy is one of the most common neurological diseases in the world, affecting about 1% of the world's population. People of different ages (children or young people), gender (males or females) and races (white or yellow) are likely to suffer from this disease. (Diacomit) is a new type of anti-epileptic drug that exerts anti-epileptic effects by enhancing GABA-mediated neurotransmission. In foreign countries, it is often used together with VPA and Clobazam (not marketed in China) to treat Dravet syndrome (a refractory epilepsy syndrome). But will the use of stiripentol cause depression and suicidal behavior?

Will using stiripentol cause depression and suicidal behavior?

AEDs, including DIACOMIT, increase the risk of suicidal thoughts or behavior in patients taking these medications for any indication. Patients receiving DIACOMIT for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behaviors, and/or any unusual changes in mood or behavior.

Clinical data on the use of stiripentol to induce suicidal behavior in depression

A pooled analysis of 199 placebo-controlled clinical trials (monotherapy and adjuvant therapy) of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk of suicidal thoughts or behaviors compared with patients randomized to placebo (adjusted relative risk 1.8, 95% confidence interval [CI]: 1.2, 2.7). In these trials, with a median treatment duration of 12 weeks, the estimated incidence of suicidal behavior or ideation was 0.43% among 27,863 AED-treated patients, compared with 0.24% among 16,029 placebo-treated patients, indicating an additional case of approximately 1 case of suicidal ideation or behavior for every 530 treated patients. There were four suicides in patients treated with the drug and no suicides in patients treated with placebo in the trial, but the numbers were too small to draw any conclusions about the drug's effect on suicide.

The increased risk of AED suicidal thoughts or behaviors was observed as early as one week after initiating AED medication and persisted during the treatment period evaluated. Because most trials included in the analysis did not exceed 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed.

In the data analyzed, the risk of suicidal thoughts or behavior was largely consistent between drugs. The findings of increased risk across AEDs with different mechanisms of action and across a range of indications suggest that the risk applies to all AEDs used for any indication. Risk did not change significantly with age (5-100 years) in the clinical trials analyzed.

The relative risk of suicidal thoughts or behaviors was higher in epilepsy clinical trials than in psychiatric or other disease clinical trials, but the absolute risk differences were similar for epilepsy and psychiatric indications.

Patients, their caregivers, and families should be informed that AEDs increase the risk of suicidal thoughts and behaviors and should be informed of the need to be alert for the emergence or worsening of signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behaviors, or thoughts of self-harm. Behavior of concern should be reported immediately to a health care provider.

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