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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
In a case series, 3 women (aged 45−66 years) were described, who developed mania (1 patient) or hypomania (2 patients) during treatment with escitalopram for major depressive disorder [routes not stated].
Patient A: A 50-year-old woman, who had not previously experienced depressive or manic episodes, and had no family history of mental illness, presented with a four month history of insomnia, decreased motivation, diminished concentration and depressed mood. She underwent menopause at the age of 45 years. Her thyroid gland functioning was normal. She was then diagnosed with major depressive disorder according to fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM−5) criteria. Subsequently, she started receiving escitalopram 10 mg/day. After 14 days,...
- Yamaguchi Y, et al. Dosage-related nature of escitalopram treatment-emergent mania/hypomania: A case series. Neuropsychiatric Disease and Treatment 14: 2099-2104, Jan 2018. Available from: URL: http://doi.org/10.2147/NDT.S168078 - Japan