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Botox may improve moderate, severe depression
Allergan recently announced positive findings that indicated Botox as a potential treatment for moderate-to-severe major depressive disorder in adult females.
“We are encouraged by these data and the potential impact on adults with major depressive disorder. Given our in-depth and extensive clinical trial experience in CNS including depression, we plan to move forward and develop a phase 3 program for a potential new treatment option for patients,” C. David Nicholson, PhD, chief research and development officer of Allergan, said in a press release.
To assess efficacy, safety and tolerability of a single administration of two different doses of Botox (onabotulinumtoxinA, Allergan) for major depressive disorder (MDD) in adult females, researchers conducted a phase 2, multicenter, randomized, double-blind, placebo-controlled study among 258 women with a minimum total score of 18 on the Hamilton Rating Scale for Depression (HAM-D) and 4 on the Clinical Global Impressions (CGI-S) scale. Study participants were randomly assigned to receive 30 units or 50 units of Botox or placebo. Study duration was 26 weeks with a 2-week screening period and up to 24 weeks post double-blind treatment.
Participants who received 30 units of Botox exhibited superior improvement in Montgomery-Asberg Depression Rating Scale (MADRS) total scores, compared with placebo. Mean treatment differences for 30 units was –4.2 (P = .005) at week 3; –3.7 (P = .053) at week 6; and –3.6 (P = .049) at week 9.
At week 6, 50 units of Botox did not exhibit superior efficacy, compared with placebo, with a mean treatment difference of 1.3.
HAM-D and CGI-S scores were superior to placebo for 30 units of Botox but not 50 units.
Both dosages were well-tolerated, according to the release.