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Abstract Details

Changes in Depression and Anxiety in a Randomized, Double-blind, Placebo-controlled Study of Galcanezumab in Adults with Treatment-resistant Migraine: Results from the CONQUER Study
Headache
P6 - Poster Session 6 (12:00 PM-1:00 PM)
7-008
While depression and anxiety are well-described migraine comorbidities, little is known about the effects of migraine prevention on these comorbidities.
Evaluate changes in measures of depression and anxiety after 3 months of galcanezumab treatment in patients with prior migraine preventive treatment failures.
Adults with episodic or chronic migraine and multiple preventive treatment failures received 3-month treatment with galcanezumab 120mg/month (n=232) or placebo (n=230). Patients rated symptoms and severity of depression and anxiety using Patient Health Questionnaire-9 (PHQ-9) and 7-item Generalized Anxiety Disorder Scale (GAD-7) at baseline and endpoint. The PHQ-9 algorithm for possible major depressive disorder (MDD) is based on the Diagnostic and Statistical Manual (DSM-IV) criteria for MDD. The criterion for possible anxiety disorder is a GAD-7 total score ≥10.

The percent of patients with “minimal” depressive symptoms (PHQ-9 total score=0-4) increased from 30.6% baseline to 54.3% after 3 months galcanezumab treatment (difference=23.7%), compared with a change from 28.7% baseline to 42.3% (difference=13.6%) with placebo. Percent of patients with possible MDD decreased from 12.9% at baseline to 6.3% after 3 months galcanezumab treatment and from 15.7% baseline to 9.9% with placebo. Mean decrease in PHQ-9 (mean baseline score=7.7) was greater in galcanezumab-treated patients vs placebo (-2.1 vs -1.2; p=0.009), and a greater proportion of galcanezumab-treated patients reported “not at all” on individual PHQ items.

Percent of patients with possible anxiety disorder decreased from 13.8% at baseline to 8.5% after 3 months with galcanezumab treatment and from 15.7% baseline to 14.4% with placebo. The mean decrease in GAD-7 (mean baseline score=4.9) was numerically greater in galcanezumab-treated patients vs placebo, without statistical significance (-0.9 vs -0.4; p=0.069).
More galcanezumab-treated patients achieved a state of “minimal” depressive symptomatology and experienced significantly greater reductions in depressive symptoms compared with placebo. Anxiety ratings decreased at endpoint but did not differ significantly between treatment groups.
Authors/Disclosures
Morris Maizels
PRESENTER
No disclosure on file
Dawn C. Buse, PhD (Dawn C. Buse, PhD) Dr. Buse has received personal compensation for serving as an employee of Vector Psychometric Group. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie-Allergan. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amgen. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lilly. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lundbeck. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Collegium. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Teva. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lilly. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie-Allergan. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck. Dr. Buse has received personal compensation in the range of $0-$499 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Current Pain and Headache Reports. The institution of Dr. Buse has received research support from Amgen. The institution of Dr. Buse has received research support from FDA. The institution of Dr. Buse has received research support from National Headache Foundation.
Jakub Jedynak Jakub Jedynak has received personal compensation for serving as an employee of Lilly. Jakub Jedynak has received stock or an ownership interest from Lilly.
Austin L. Hand Austin L. Hand has received personal compensation for serving as an employee of IQVIA. Austin L. Hand has received personal compensation for serving as an employee of Corcept Therapeutics .
Janet Ford Janet Ford has received personal compensation for serving as an employee of Eli Lilly and Company . Janet Ford has received stock or an ownership interest from Eli Lilly and Company .
Holland Detke Holland Detke has received personal compensation for serving as an employee of Eli Lilly and Company. Holland Detke has received stock or an ownership interest from Eli Lilly and Company.