Fremanezumab Shows Dual Efficacy in Treating Migraine and Comorbid Major Depressive Disorder: JAMA
Researchers have found in a new study that Fremanezumab proved effective in reducing symptoms of both migraine and comorbid major depressive disorder in patients suffering from both conditions. The study was conducted by Richard B. L. and fellow researchers published in JAMA Neurology. Although migraine and major depressive disorder (MDD) frequently co-occur, evidence for effective treatment approaches for both conditions at the same time has been sparse. The UNITE study bridges this gap by evaluating fremanezumab, a calcitonin gene–related peptide (CGRP) monoclonal antibody indicated for migraine prevention in a patient population with both migraine (episodic or chronic) and MDD with active symptoms.
The UNITE trial was a double-blind, placebo-controlled, parallel-group trial from July 9, 2020, to August 31, 2022, at 55 centers in 12 countries. The trial consisted of a 4-week screening period, a 12-week double-blind treatment period, and a 12-week open-label extension (OLE).
540 adults were screened, of whom 353 patients were enrolled and randomized: 175 to fremanezumab (225 mg per month), and 178 to placebo. Participants were eligible if they had episodic migraine (48%) or chronic migraine (52%), along with a DSM-5-diagnosis major depressive disorder for ≥12 months, and a score of active depressive symptoms (PHQ-9 ≥10) at screening. For the OLE phase, all patients received quarterly fremanezumab (675 mg).
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