Nov 13, 2019
Michelle
Magid, MD, conducts a Masterclass lecture on botulinum toxin
for depression from the
Psychopharmacology Update in Cincinnati. The meeting was
sponsored by Global
Academy for Medical Education and Current Psychiatry.
Dr. Magid is associate professor University of Texas in Austin,
and associate professor of Texas A&M University in College
Station. She disclosed serving as a speaker for Ipsen, maker of
Dysport (abobotulinumtoxinA, or ABO), and as a consultant for
Allergan, maker of Botox (onabotulinumtoxinA).
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This week in
psychiatry:
Conduct disorder in girls gets overdue research attention
by Bruce Jancin
The physiological and emotion-procession abnormalities that
underpin conduct disorder in teen girls are essentially the same as
in teen boys. however, the clinical presentation of conduct
disorder in the two groups is often different.
What we know about botulinum toxin
- Botulinum toxin is the product of Clostridium
botulinum. The neurotoxin inhibits the release of
acetylcholine, resulting in flaccid muscle relaxation. Its clinical
use started in 1989 to treat strabismus
(crossed eyes) and blepharospasm,
a dystonic reaction in the eyes. Currently, botulinum is a Food and
Drug Administration–approved treatment of
chronic migraine in adults.
- For use in depression, 30-40 units of botulinum toxin is
injected into the glabellar region of the face (the forehead). A
purported mechanism of action of botulism for depression includes
the “facial feedback hypothesis,” in which the activation of
muscles of facial expression, consciously or unconsciously,
influences emotions.
- Botulinum toxin for depression is an off-label treatment with
four case series, five randomized, controlled studies, and a phase
2 trial by supported by Allergan.
New findings on use of botulinum toxin for
depression
- Magid and colleagues completed a pooled analysis of three
randomized, controlled trials totaling 134 patients. Fifty-nine
people were included in the botulinum toxin intervention group with
a Beck Depression Inventory (BDI)
score of 29, and 75 individuals in the placebo group with BDI of
26. In each group, 64% of patients were continued on other
medications for depression, and the groups had similar histories of
long-standing depression.
- In the botulinum toxin group, 52% had a response to the
intervention, with an at least 50% reduction in their baseline
depression scores, compared with a limited response in the placebo
group.
- In the pooled analysis, Dr. Magid’s group analyzed whether the
cosmetic effect of botulinum toxin could be a confounding factor.
The investigators ruled out that effect by using a subanalysis to
evaluate whether the decrease in wrinkles correlated with decrease
in depression, and it did not.
- Allergan moved forward with a phase 2 proof-of-concept trial;
the results were mixed. The endpoint was response rate in
Montgomery-Åsberg Depression Rating Scale (MADRS)
at week 6. With a 30-unit Botox dose, there was a statistically
significant decrease in MADRS at week 9, but not at week 6. There
was no statistically significant divergence in data between the
placebo and intervention group with the 50-unit dose. Given the
response rate at week 9, Allergan is proceeding with a phase 3
trial.
- The cost is about $400 per treatment, and the treatment is
given three to four times a year, which makes the cost comparable
to that of other psychopharmacologic treatments. Adverse events are
mild and include headache and local site irritation. In the current
studies, botulinum treatment has been used as both monotherapy and
augmentation; however, there are not enough data to know whether
one is more effective than the other.
- In conclusion, burgeoning psychopharmacology research on
treatments such as botulinum toxin for depression and novel
medications, such as
esketamine and
brexanolone, broaden our understanding of the etiology of
depression. This research is generating novel modes of treatment
that will help more patients with refractory illness.
References
Magid M et al. Treating depression with botulinum toxin: A
pooled analysis of randomized controlled trials.
Psychopharmacology. 2015 Sep;48(6):205-10.
Magid M et al. Treatment of major depressive disorder using
botulinum toxin: A 24-week randomized, double-blind,
placebo-controlled study.
J Clin Psychiatry. 2014 Aug;75(8):837-44.
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