Evidence map›Paper›PMID 30626409›Full record

ArticleTrials2019

Scopolamine augmentation of a newly initiated escitalopram treatment for major depressive disorder: study protocol for a randomized controlled trial.

Jingjing Zhou, Weiwei Wang, Jian Yang, Xuequan Zhu, Lei Feng, Le Xiao, Gang Wang

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03131050 (A Double-blind, Controlled, Randomized Study Comparing Escitalopram Combined With Scopolamine or Escitalopram in Patients With Major Depressive Disorder), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.7field-weighted citation impact, top 17% of its field
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.

NCT03131050 phase4completednot on this map

A Double-blind, Controlled, Randomized Study Comparing Escitalopram Combined With Scopolamine or Escitalopram in Patients With Major Depressive Disorder

TypeinterventionalSponsorCapital Medical UniversityRan2017 to 2018Enrolled66ConditionsMajor Depressive DisorderArmsScopolamine, Escitalopram, Saline
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 13 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
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 at 2 institutions in 1 country.

Jingjing ZhouNational Clinical Research Center for Mental Disorders & Beijing Key Laboratory of Mental Disorders, Beijing Anding Hospital, Capital Medical University, No. 5 Ankang Lane, Deshengmenwai Avenue, Xicheng District, Beijing, 100088, China.
Weiwei WangNational Clinical Research Center for Mental Disorders & Beijing Key Laboratory of Mental Disorders, Beijing Anding Hospital, Capital Medical University, No. 5 Ankang Lane, Deshengmenwai Avenue, Xicheng District, Beijing, 100088, China.
Jian YangNational Clinical Research Center for Mental Disorders & Beijing Key Laboratory of Mental Disorders, Beijing Anding Hospital, Capital Medical University, No. 5 Ankang Lane, Deshengmenwai Avenue, Xicheng District, Beijing, 100088, China.
Xuequan ZhuNational Clinical Research Center for Mental Disorders & Beijing Key Laboratory of Mental Disorders, Beijing Anding Hospital, Capital Medical University, No. 5 Ankang Lane, Deshengmenwai Avenue, Xicheng District, Beijing, 100088, China.
Lei FengNational Clinical Research Center for Mental Disorders & Beijing Key Laboratory of Mental Disorders, Beijing Anding Hospital, Capital Medical University, No. 5 Ankang Lane, Deshengmenwai Avenue, Xicheng District, Beijing, 100088, China.
Le XiaoNational Clinical Research Center for Mental Disorders & Beijing Key Laboratory of Mental Disorders, Beijing Anding Hospital, Capital Medical University, No. 5 Ankang Lane, Deshengmenwai Avenue, Xicheng District, Beijing, 100088, China.
Gang WangNational Clinical Research Center for Mental Disorders & Beijing Key Laboratory of Mental Disorders, Beijing Anding Hospital, Capital Medical University, No. 5 Ankang Lane, Deshengmenwai Avenue, Xicheng District, Beijing, 100088, China. 13366765266@163.com.
Beijing Anding Hospital · CNCapital Medical University · CN

Funding

Beijing Municipal Administration of Hospitals Clinical Medicine Development of Special Funding Support ZYLX201607Dengfeng Talent Support Program of Beijing Municipal Administration of Hospitals DFL20151801National Key Research&Development Program of China 2016YFC1307200
6 · The paper itself

Abstract

backgroundMajor depressive disorder (MDD) is a prevalent and disabling disorder that can lead to heavy individual, familial, and societal burdens. Although pharmaceutical interventions still play an essential role in therapeutic measures, limitations, including effects that are delayed for weeks, are noteworthy. Antidepressants with rapid efficacy and acceptable tolerance have been investigated for many years; rapid antidepressant effects and promising clinical applications have been obtained with intravenous and oral scopolamine. This study aims to evaluate the efficacy of repeated intramuscular scopolamine as an add-on treatment to escitalopram.

methodsThis is a single-center, saline-controlled, double-blind, three-armed, randomized trial. Sixty-six participants diagnosed with MDD will be recruited at Beijing Anding Hospital and randomly assigned to one of three groups: a high-dose intramuscular scopolamine augmentation group; a low-dose intramuscular scopolamine augmentation group; and a placebo control group. Our primary endpoint is improvement in the 17-Item Hamilton Rating Scale for Depression (HRSD17) score from the baseline (at least a 20% reduction). Prespecified secondary endpoints include response rates and remission rates as well as changes in the total or subscale scores between the baseline and week 4. DISCUSSION: This study will provide the first insight regarding the rapid antidepressant efficacy and tolerability of an intramuscular scopolamine add-on to the usual treatment in Chinese MDD patients. The first discussion concerns whether augmentation can accelerate early antidepressant efficacy. A pilot study of intramuscular scopolamine is performed. The limitations of this study include its small sample size and it being a single-center study, suggesting the need for further confirmation with trials enrolling larger populations. ETHICS AND DISSEMINATION: The study protocol and all related materials have been approved by the Institutional Ethics Committee of the Beijing Anding Hospital (No. 2016-106, Beijing, China). The findings will be disseminated through peer-reviewed journals and at national and international conferences.

trial registrationClinicalTrials.gov, NCT03131050 . Registered on 18 April 2017.

Indexed as

Administration, OralAdolescentAdultAffectAntidepressive Agents, Second-GenerationBeijingCitalopramDouble-Blind MethodDrug SynergismDrug Therapy, CombinationFemaleHumansInjections, IntramuscularMajor Depressive DisorderMaleMiddle AgedAntidepressive Agents, Second-GenerationCitalopramMuscarinic AntagonistsScopolamineSelective Serotonin Reuptake InhibitorsEfficacyMajor depressive disorderRandomized controlled trialScopolamine

Identifiers

PMID30626409
PMCPMC6327471
OpenAlexW2917909954

What OpenQuestion holds

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LicenceCC BY
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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.