Evidence map›Paper›PMID 34992372›Full record

ArticleNeuropsychiatric disease and treatment2021

Therapeutic Potential of Vortioxetine for Anxious Depression: A Post Hoc Analysis of Data from a Clinical Trial Conducted in Japan.

Takeshi Inoue, Shinji Fujimoto, Tatsuro Marumoto, Tadayuki Kitagawa, Kazuyuki Ishida, Tadashi Nakajima, Yoshiya Moriguchi, Keita Fujikawa, Koichiro Watanabe

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Neuropsychiatric disease and treatment, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02389816 (A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase III Study to Evaluate the Efficacy and Safety of Once Daily Oral Lu AA21004 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
0.5field-weighted citation impact, top 32% 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.

NCT02389816 phase3completednot on this map

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase III Study to Evaluate the Efficacy and Safety of Once Daily Oral Lu AA21004 in Patients With Major Depressive Disorder

TypeinterventionalSponsorTakedaRan2015 to 2018Enrolled493ConditionsMajor Depressive DisorderArmsPlacebo, Vortioxetine
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Trial
  2. Review
  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

9 authors at 3 institutions in 1 country.

Takeshi InoueDepartment of Psychiatry, Tokyo Medical University, Tokyo, Japan.ORCID 0000-0001-5248-1289
Shinji FujimotoJapan Medical Office, Takeda Pharmaceutical Co., Ltd, Tokyo, Japan.ORCID 0000-0002-7990-4699
Tatsuro MarumotoJapan Medical Office, Takeda Pharmaceutical Co., Ltd, Tokyo, Japan.
Tadayuki KitagawaTakeda Development Center - Japan, Takeda Pharmaceutical Co., Ltd, Osaka, Japan.
Kazuyuki IshidaTakeda Development Center - Japan, Takeda Pharmaceutical Co., Ltd, Osaka, Japan.
Tadashi NakajimaJapan Medical Office, Takeda Pharmaceutical Co., Ltd, Tokyo, Japan.
Yoshiya MoriguchiMedical Affairs, Lundbeck Japan K.K., Tokyo, Japan.ORCID 0000-0001-9248-8864
Keita FujikawaJapan Medical Office, Takeda Pharmaceutical Co., Ltd, Tokyo, Japan.
Koichiro WatanabeDepartment of Neuropsychiatry, Kyorin University School of Medicine, Tokyo, Japan.ORCID 0000-0002-0736-7070
Takeda (Japan) · JPKyorin University · JPTokyo Medical University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimAntidepressants, including selective serotonin reuptake inhibitors, often elicit a poor response in patients with major depressive disorder (MDD) with significant anxiety symptoms. This study investigated the effects of the multimodal antidepressant vortioxetine in patients with MDD and associated anxiety.

methodsThis was a post hoc analysis of data from an 8-week, randomized, double-blind, placebo-controlled, Phase 3 study of vortioxetine (10 mg or 20 mg) in Japanese patients aged 20-75 years with recurrent MDD and a Montgomery-Åsberg Depression Rating Scale (MADRS) score of at least 26. Changes from baseline to week 8 in MADRS total score and Hamilton Depression Rating Scale (HAM-D) anxiety/somatization factor score were assessed in patients with anxious depression (HAM-D anxiety/somatization factor score ≥7) and without anxious depression.

resultsData were available for 489 patients. In patients with anxious depression, the least-squares (LS) mean difference (95% confidence interval [CI]) versus placebo in change in MADRS total score was -3.44 (-6.10, -0.77) for vortioxetine 10 mg and -4.51 (-7.15, -1.87) for vortioxetine 20 mg. In patients with non-anxious depression, the LS mean difference (95% CI) versus placebo was -1.81 (-4.71, 1.09) and -1.05 (-4.00, 1.90) for vortioxetine 10 mg and 20 mg, respectively. Changes from baseline in HAM-D anxiety/somatization factor score were greater in patients treated with vortioxetine 10 mg or 20 mg than in those treated with placebo.

conclusionVortioxetine may be effective for patients with anxiety symptoms in MDD. Further research is warranted to investigate these effects in a real-world clinical setting. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov identifier for primary study: NCT02389816.

Indexed as

antidepressantanxietymajor depressive disorderserotonin reuptake inhibitor and modulator (S-RIM)vortioxetine

Identifiers

PMID34992372
PMCPMC8710584
OpenAlexW4200435091

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.