Evidence map›Paper›PMID 31323045›Full record

Trial reportPloS one2019

Effects of the antidepressant medication duloxetine on brain metabolites in persistent depressive disorder: A randomized, controlled trial.

Ravi Bansal, David J Hellerstein, Siddhant Sawardekar, Joseph O'Neill, Bradley S Peterson

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00360724 (Duloxetine for Chronic Depression), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.9field-weighted citation impact, top 26% 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.

NCT00360724 phase4completednot on this map

Duloxetine for Chronic Depression: a Double-blind Study

TypeinterventionalSponsorNew York State Psychiatric InstituteRan2006 to 2013Enrolled65ConditionsDysthymic Disorder, Depressive Disorder NOSArmsDuloxetine (Cymbalta)
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 6 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
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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

5 authors at 4 institutions in 1 country.

Ravi BansalInstitute for the Developing Mind, Children's Hospital Los Angeles, Los Angeles, CA, United States of America.ORCID 0000-0003-4394-8355
David J HellersteinDepression Evaluation Service, Division of Clinical Therapeutics, New York State Psychiatric Institute, New York, NY, United States of America.
Siddhant SawardekarInstitute for the Developing Mind, Children's Hospital Los Angeles, Los Angeles, CA, United States of America.
Joseph O'NeillDivision of Child and Adolescent Psychiatry, University of California-Los Angeles, Los Angeles, CA, United States of America.
Bradley S PetersonInstitute for the Developing Mind, Children's Hospital Los Angeles, Los Angeles, CA, United States of America.
University of Southern California · USChildren's Hospital of Los Angeles · USNew York Psychoanalytic Society and Institute · USUniversity of California, Los Angeles · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTo assess whether patients with Persistent Depressive Disorder (PDD) have abnormal levels of N-acetyl-aspartate (NAA) and whether those levels normalize following treatment with the antidepressant medication duloxetine. Furthermore, we conducted post hoc analyses of other important brain metabolites to understand better the cellular and physiological determinants for changes in NAA levels.

methodsWe acquired proton (1H) magnetic resonance spectroscopic imaging (MRSI) data on a 3 Tesla (3T), GE Magnetic Resonance Imaging (MRI) scanner in 41 patients (39.9±10.4 years, 22 males) with PDD at two time points: before the start and at the end of a 10-week, placebo-controlled, double-blind, randomized controlled trial (RCT) of the antidepressant medication duloxetine. Patients were randomized such that 21 patients received the active medication and 20 patients received placebo during the 10 week period of the trial. In addition, we acquire 1H MRSI data once in 29 healthy controls (37.7±11.2 years, 17 males).

findingsPatients had significantly higher baseline concentrations of NAA across white matter (WM) pathways and subcortical gray matter, and in direct proportion to the severity of depressive symptoms. NAA concentrations declined in duloxetine-treated patients over the duration of the trial in the direction toward healthy values, whereas concentrations increased in placebo-treated patients, deviating even further away from healthy values. Changes in NAA concentration did not mediate medication effects on reducing symptom severity, however; instead, changes in symptom severity partially mediated the effects of medication on NAA concentration, especially in the caudate and putamen.

interpretationThese findings, taken together, suggest that PDD is not a direct consequence of elevated NAA concentrations, but that a more fundamental pathophysiological process likely causes PDD and determines the severity of its symptoms. The findings also suggest that although duloxetine normalized NAA concentrations in patients, it did so by modulating the severity of depressive symptoms. Medication presumably reduced depressive symptoms through other, as yet unidentified, brain processes.

trial registrationClinicalTrials.gov NCT00360724.

Indexed as

AdultAntidepressive AgentsAspartic AcidBrainDouble-Blind MethodDuloxetine HydrochlorideFemaleHumansMagnetic Resonance ImagingMagnetic Resonance SpectroscopyMajor Depressive DisorderMaleMiddle AgedTreatment OutcomeAntidepressive AgentsAspartic AcidDuloxetine HydrochlorideN-acetylaspartate

Identifiers

PMID31323045
PMCPMC6641507
OpenAlexW2963280947

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.