Evidence map›Paper›PMID 26807672›Full record

Trial reportJournal of affective disorders2016

An assessment of the anti-fatigue effects of ketamine from a double-blind, placebo-controlled, crossover study in bipolar disorder.

Leorey N Saligan, David A Luckenbaugh, Elizabeth E Slonena, Rodrigo Machado-Vieira, Carlos A Zarate

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of affective disorders, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04141696 (A Proof-of-Concept Trial on the Effect of Ketamine on Fatigue), which is not on this map. Cited by 22 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 1 pooled it
4.2field-weighted citation impact, top 6% 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.

NCT04141696 phase1 / phase2completednot on this mapstarted 2021, after this paper: background citation

A Proof-of-Concept Trial on the Effect of Ketamine on Fatigue

TypeinterventionalSponsorNational Institute of Nursing Research (NINR)Ran2021 to 2024Enrolled10ConditionsFatigueArmsKetamine, Midazolam
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 1 synthesis or guideline pooled it, 47 citations in OpenAlex.

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  4. Dose-Related Effects of Adjunctive Ketamine in Taiwanese Patients with Treatment-Resistant Depression.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2017
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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 2 institutions in 1 country.

Leorey N SaliganNational Institute of Nursing Research, Division of Intramural Research, National Institutes of Health, 31 Center Drive, MSC 2178, Bethesda, MD 209892, USA. Electronic address: saliganl@mail.nih.gov.
David A LuckenbaughExperimental Therapeutics & Pathophysiology Branch, Intramural Research Program, National Institute of Mental Health, 10 Center Drive, Rm 4N222, MSC 1381 Bethesda, MD 20892, USA. Electronic address: luckenbd@mail.nih.gov.
Elizabeth E SlonenaExperimental Therapeutics & Pathophysiology Branch, Intramural Research Program, National Institute of Mental Health, 10 Center Drive, Rm 4N222, MSC 1381 Bethesda, MD 20892, USA. Electronic address: elizabeth.slonena@nih.gov.
Rodrigo Machado-VieiraExperimental Therapeutics & Pathophysiology Branch, Intramural Research Program, National Institute of Mental Health, 10 Center Drive, Rm 4N222, MSC 1381 Bethesda, MD 20892, USA. Electronic address: rodrigo.machadovieira@nih.gov.
Carlos A ZarateExperimental Therapeutics & Pathophysiology Branch, Intramural Research Program, National Institute of Mental Health, 10 Center Drive, Rm 4N222, MSC 1381 Bethesda, MD 20892, USA. Electronic address: zaratec@mail.nih.gov.
National Institute of Mental Health · USNational Institute of Nursing Research · US

Funding

Investigating Molecular-Genetic Correlates of FatigueZIANR000019 · NINR · NATIONAL INSTITUTE OF NURSING RESEARCH · PI SALIGAN, LEOREY · 2010 to 2025
$12.8M
Intramural NIH HHS Z99 NR999999
6 · The paper itself

Abstract

backgroundFatigue is a multidimensional condition that is difficult to treat with standard monoaminergic antidepressants. Ketamine, an N-methyl-D-aspartate receptor (NMDAR) antagonist produces rapid and robust improvements in depressive symptoms in treatment-resistant depression. However, there is a dearth of literature examining the anti-fatigue effects of ketamine. We hypothesize that ketamine will rapidly improve fatigue symptoms in treatment-resistant depressed patients.

methodsThis is an exploratory analysis of data obtained from two double-blind, randomized, placebo-controlled, crossover trials. A total of 36 participants with treatment-resistant bipolar I or II disorder in a depressive episode (maintained on therapeutic levels of lithium or valproate) received a single infusion of ketamine hydrochloride intravenously (0.5 mg/kg over 40 min) or placebo. A post-hoc analysis compared fatigue scores on ketamine vs. placebo at 10 time points from baseline through 14 days post-treatment using the National Institute of Health-Brief Fatigue Inventory.

resultsA linear mixed model showed that ketamine significantly lowered fatigue scores compared to placebo from 40 min post-treatment to Day 14 with the exception of Day 7. The largest difference in anti-fatigue effects between placebo and ketamine was at day 2 (d=0.58, p<0.05). The effect remained significant after controlling for changes in non-fatigue depressive symptoms. LIMITATION: The retrospective nature and a small sample size are study limitations.

conclusionsKetamine rapidly improved fatigue relative to placebo in a group of individuals with treatment-resistant bipolar depression. NMDAR is a glutamate receptor; hence, glutamate may represent a valuable target to study the clinical efficacy of new anti-fatigue approaches in multiple disorders.

Indexed as

AdultBipolar DisorderCross-Over StudiesDepressive Disorder, Treatment-ResistantDouble-Blind MethodFatigueFemaleHumansKetamineMaleMiddle AgedReceptors, N-Methyl-D-AspartateRetrospective StudiesTreatment OutcomeKetamineReceptors, N-Methyl-D-AspartateDepressionFatigueGlutamateKetamineNew therapeutics

Identifiers

PMID26807672
PMCPMC4769920
OpenAlexW2287332285

What OpenQuestion holds

Textmetadata
LicenceTDM
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.