Evidence map›Paper›PMID 31609787›Full record

Trial reportInternational clinical psychopharmacology2020

OnabotulinumtoxinA for the treatment of major depressive disorder: a phase 2 randomized, double-blind, placebo-controlled trial in adult females.

Mitchell F Brin, Suresh Durgam, Arlene Lum, Lynn James, Jeen Liu, Michael E Thase, Armin Szegedi

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International clinical psychopharmacology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02116361 (BOTOX®), which is not on this map. Cited by 30 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 6 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02116361 phase2completednot on this map

BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex as Treatment for Major Depressive Disorder in Adult Females

TypeinterventionalSponsorAllerganRan2014 to 2016Enrolled258ConditionsDepressive Disorder, MajorArmsonabotulinumtoxinA, Normal Saline
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 6 syntheses or guidelines pooled it.

  1. Pooled it
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  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Trial
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  9. Review
  10. Article
  11. Review
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  13. A Critical View on New and Future Antidepressants.Clinical psychopharmacology and neuroscience : the official scientific journal of the Korean College of Neuropsychopharmacology · 2024
    Review
  14. Article
  15. Article
  16. Review
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  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Mitchell F BrinAllergan, Irvine, California.
Suresh DurgamFormer Allergan Employee, Madison, New Jersy.
Arlene LumAllergan, Irvine, California.
Lynn JamesAllergan, Irvine, California.
Jeen LiuAllergan, Irvine, California.
Michael E ThasePerelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
Armin SzegediAllergan, Madison, New Jersy, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This 24-week double-blind placebo-controlled multicenter randomized phase 2 trial evaluated efficacy and safety of onabotulinumtoxinA (onabotA; BOTOX) vs. placebo for major depressive disorder (MDD) [NCT02116361]. Primary endpoint was the change in Montgomery-Åsberg Depression Rating Scale (MADRS); secondary endpoints were Clinical Global Impressions-Severity and 17-item Hamilton Depression Rating Scale at week 6. A total of 255 adult females were treated. OnabotA 30 U approached significance compared to placebo on MADRS (mixed-effect model repeated measures least-squares mean difference: -3.7; P = 0.053) and reached significance [least-squares mean differences: -3.6 to -4.2; P < 0.05 (two-sided)] at weeks 3 and 9. Secondary endpoints were also significant at several time points. At week 6, onabotA 50 U did not separate from placebo in any parameters. OnabotA was generally well-tolerated: the only treatment-emergent adverse events reported in ≥5% in either onabotA group, and more than matching placebo were headache, upper respiratory infection, and eyelid ptosis. OnabotA 30 U, administered in a standardized injection pattern in a single session, had a consistent efficacy signal across multiple depression symptom scales for 12 or more weeks. OnabotA 30 U/placebo MADRS differences of (observed ANCOVA) ≥4.0 points (up to week 15) and ≥2.0 points (weeks 18-24) agree with the 2-point change threshold considered clinically relevant in MDD. OnabotA is a local therapy and is not commonly associated with systemic effects of conventional antidepressants and may represent a novel treatment option for MDD.

Indexed as

AdolescentAdultAgedBotulinum Toxins, Type ADouble-Blind MethodFemaleHumansInjections, IntramuscularMajor Depressive DisorderMiddle AgedYoung AdultBotulinum Toxins, Type Aonabotulinum toxin A

Identifiers

PMID31609787
PMCPMC6903360

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.