Fremanezumab Reduces Migraine Days, Depressive Symptoms in Patients with Migraine and Comorbid MDD
Compared with placebo, fremanezumab significantly reduced both monthly migraine days and depressive symptoms in patients with migraine and moderate to severe comorbid major depressive disorder (MDD), according to a study published in JAMA Neurology.
“To the authors’ knowledge, this was the first placebo-controlled, randomized clinical trial, specifically designed to assess patients with migraine and comorbid depressive disorder, to demonstrate significant improvements in migraine and depressive symptoms with a single pharmacological intervention,” wrote corresponding author Richard B. Lipton, MD, of the Albert Einstein College of Medicine, New York, New York, and study coauthors.
The UNITE study consisted of a 4-week screening period, 12-week double-blind period, and 12-week open-label extension (OLE). Conducted at 55 centers across 12 counties, the trial included 353 adults with episodic or chronic migraine and a history of MDD lasting at least 12 months before screening. At screening, participants also had scores of 10 or higher on the 9-item Patient Health Questionnaire, indicating active symptoms of depression.
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Among participants, 175 were randomized to monthly fremanezumab (225 mg), and 178 to placebo. During the OLE, all patients received quarterly fremanezumab (675 mg).
At baseline, the mean number of monthly migraine days were 15.1 in the fremanezumab group and 14.4 days in the placebo groups. By the end of the 12-week double-blind period, monthly migraine days decreased an average 5.1 days with fremanezumab and 2.9 days with placebo, according to the study.
Baseline Hamilton Depression Rating Scale–17 Items (HAM-D 17) scores were 16.2 in each treatment group, reflecting moderate to severe depression. At week 8, HAM-D 17 scores were down 6.0 points in the fremanezumab group and 4.6 points in the placebo group.
Fremanezumab was well tolerated, and adverse events were consistent with other fremanezumab trials. Investigators identified no suicidality risks or new safety signals.
Throughout the 12-week OLE, results were sustained and became numerically larger, researchers reported.
“The results of the UNITE study suggest that fremanezumab was effective in a difficult to treat clinical population with migraine and comorbid major depressive disorders and may also be effective in alleviating psychiatric comorbidities,” the authors wrote, “therefore reducing the cumulative burden on patients.”
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