Evidence map›Paper›PMID 34090255›Full record

Trial reportEuropean neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology2021

The effect of single administration of intravenous ketamine augmentation on suicidal ideation in treatment-resistant unipolar depression: Results from a randomized double-blind study.

Anna Feeney, Rebecca S Hock, Marlene P Freeman, Martina Flynn, Bettina Hoeppner, Dan V Iosifescu, Madhukar H Trivedi, Gerard Sanacora, Sanjay J Mathew, Charles Debattista and 3 more

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01920555 (Double-Blind, Placebo-Controlled Trial of Ketamine Therapy in Treatment-Resistant Depression), which is not on this map. Cited by 17 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 4 pooled it
3.6field-weighted citation impact, top 7% 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.

NCT01920555 phase2completednot on this map

Double-Blind, Placebo-Controlled Trial of Ketamine Therapy in Treatment-Resistant Depression (TRD)

TypeinterventionalSponsorMassachusetts General HospitalRan2014 to 2017Enrolled99ConditionsTreatment Resistant DepressionArmsKetamine, Placebo Midazolam
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 4 syntheses or guidelines pooled it, 32 citations in OpenAlex.

  1. Pooled it
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  4. Pooled it
  5. Trial
  6. Trial
  7. Review
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  12. Article
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  14. Suicide and Inflammation.Advances in experimental medicine and biology · 2023
    Article
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  16. Review
  17. 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

13 authors at 8 institutions in 1 country.

Anna FeeneyClinical Trials Network and Institute, Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, MA. Electronic address: afeeney3@mgh.harvard.edu.
Rebecca S HockClinical Trials Network and Institute, Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, MA.
Marlene P FreemanClinical Trials Network and Institute, Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, MA; Center for Women's Mental Health, Massachusetts General Hospital, Boston, MA.
Martina FlynnClinical Trials Network and Institute, Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, MA.
Bettina HoeppnerPsychiatry Department, Massachusetts General Hospital, Boston, MA.
Dan V IosifescuClinical Research Division, Nathan Kline Institute for Psychiatric Research, Orangeburg, NY; Department of Psychiatry, New York University School of Medicine, New York, NY.
Madhukar H TrivediDepartment of Psychiatry and Peter O'Donnell Jr. Brain Institute, University of Texas Southwestern Medical Center, Dallas, TX.
Gerard SanacoraYale University, New Haven, CT.
Sanjay J MathewMenninger Department of Psychiatry & Behavioral Sciences, Baylor College of Medicine, Houston, TX; Michael E. Debakey VA Medical Center Mental Health Care Line, Houston, TX.
Charles DebattistaStanford University School of Medicine, Stanford, CA.
Dawn F IonescuJanssen Research & Development, La Jolla, CA.
Maurizio FavaClinical Trials Network and Institute, Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, MA.
George I PapakostasClinical Trials Network and Institute, Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, MA.
Massachusetts General Hospital · USBaylor College of Medicine · USHarvard University · USJanssen (United States) · USNathan Kline Institute for Psychiatric Research · USStanford University · USThe University of Texas Southwestern Medical Center · USYale University · US

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
NCATS NIH HHS UL1 TR001863NIDA NIH HHS HHSN271201100006CNIDA NIH HHS HHSN271201100006INIMH NIH HHS HHSN271201100006I
6 · The paper itself

Abstract

This study aimed to assess the effect of a single infusion of intravenous (IV) ketamine on suicidal ideation in patients with treatment-resistant depression (TRD). Patients with TRD were randomized in a double-blind fashion to a single infusion of IV ketamine or IV midazolam placebo. Suicidal ideation was measured using the Montgomery-Asberg Depression Rating Scale (MADRS) suicide item at 3, 5, 7, 14 and 30 days post infusion. Clinically significant suicidal ideation was defined as a MADRS suicide item score ≥2. Forty patients who received IV ketamine and 16 who received IV midazolam had suicide item scores of ≥2 at baseline (IV ketamine group mean 2.90±0.74; IV midazolam group 2.69±0.70). The mean suicide scores of these groups differed significantly from each other on day 30; the IV ketamine group had a lower mean score than controls (2.03±1.59 vs. 3.00±1.41, t-test p = 0.049; Hedges' g 0.71). Among patients with a suicide score of ≥2 at baseline and <2 at day 3, the two groups did not differ significantly on mean scores changes at days 3, 5, 7, 14 or 30. Recurrence of suicidal ideation was extensive in both treatment groups. A single infusion of IV ketamine may reduce suicidal ideation in TRD out to 30 days post infusion, but early anti-suicidal effects appear to diminish rapidly. This post-hoc analysis was not powered to compare different doses of ketamine. A single infusion of IV ketamine might have a role as an adjunct to standard treatments in patients with TRD and suicidal ideation. Trial registration: NCT01920555.

Indexed as

Depressive Disorder, Treatment-ResistantKetamineDouble-Blind MethodHumansInfusions, IntravenousMidazolamPsychiatric Status Rating ScalesSuicidal IdeationKetamineMidazolamAntidepressant drugsDepressive disorder, majorDepressive disorder, treatment resistantKetamineSuicidal ideation

Identifiers

PMID34090255
PMCPMC8338746
OpenAlexW3166090728

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.