Post hoc patient-level analysis of the impact of paroxetine and sertraline of individual items of the Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria for premenstrual dysphoric disorder (PMDD)

Premenstrual dysphoric disorder (PMDD) affects approximately 2-4 % of menstruating women. It is characterized by severe symptoms both regarding mind (for example dysphoria (feelings of unease or dissatisfaction), anxiety, mood swings and irritability) and body (such as breast tenderness or bloating), that interferes with daily life. The symptoms typically occur after ovulation (when eggs are released from the ovaries), and resolve some time after the first day of menstruation. Even though it is clear that the symptoms are connected to the hormone changes during the menstrual cycle, the cause of PMDD remains unknown. The class of pharmaceuticals known as selective serotonin reuptake inhibitors (SSRIs) was initially approved for treatment of depression, but have for decades also been approved for PMDD. SSRIs are supposed to work by modulating serotonin activity in brain. Serotonin is a neurotransmitter (a messenger chemical that carries signals between nerve cells in the brain), and it is thought to help regulate mood, emotions and sleep.

Clinical studies using SSRIs for PMDD have shown a moderate effect when looking across all the symptoms to evaluate the effect. It is however quite possible that there is no effect on some of the less common symptoms, and a large effect on others. In order to clarify this we want to look at every symptom evaluated in the requested studies individually, and see if some respond very well to SSRIs while other symptoms may not respond at all. We will also try to identify any predictors for response, such as the patients’ age, severity and type of symptoms, optimal dosing and type of SSRI. This research will help to guide clinicians when considering what treatment to recommend for individuals patients.