In a recent clinical trial researchers found that fremanezumab, a migraine prevention drug, may reduce both migraine frequency and depressive symptoms in adult patients with comorbid migraine and major depressive disorder.
Researchers enrolled 353 adult patients from 12 countries with either episodic or chronic migraine and a diagnosis of major depressive disorder (MDD) for at least 1 year. Depression symptoms were active at baseline as determined by a standardized questionnaire. The participants were randomly assigned to receive monthly fremanezumab (225 mg) or placebo for 12 weeks.
After the double-blind phase, all of the participants entered a 12-week open-label extension and received fremanezumab (675 mg) quarterly.
The primary outcome of the study was change in the number of monthly migraine days after 12 weeks. Patients treated with fremanezumab had an average of 5.1 fewer migraine days per month compared with 2.9 fewer days in the placebo group.
Depressive symptoms were assessed using the Hamilton Depression Rating Scale–17 Items (HAM-D 17). Fremanezumab reduced scores by an average of 6.0 points vs 4.6 points in the placebo group.
By week 12, 40% of the patients receiving fremanezumab achieved at least a 50% reduction in monthly migraine days compared with 25% in the placebo group.
Quality of life also improved. On the Headache Impact Test (HIT-6), patients in the fremanezumab group improved by nearly 9 points compared with 5 points in the placebo group. A reduction of 8 points or more was considered clinically meaningful.
Reductions in migraine days and depressive symptoms persisted through week 24. At that point, the patients in both groups had about 7 fewer migraine days per month and average HAM-D 17 score improvements of about 8 points.
Adverse events were reported in 40% of the fremanezumab users and 27% of the placebo users. These were mostly mild or moderate and included injection-site reactions and infections. No new safety concerns were identified.
The study population was predominantly female (88%) and White (97%) with a mean age of 43 years. On average, the participants had been living with migraine for more than 20 years.
Additional research is needed to better understand the link between migraine control and mood outcomes.
Full disclosures are provided in the published study.
Source: JAMA Neurology