Evidence map›Paper›PMID 22297150›Full record

Trial reportBiological psychiatry2012

Replication of ketamine's antidepressant efficacy in bipolar depression: a randomized controlled add-on trial.

Carlos A Zarate, Nancy E Brutsche, Lobna Ibrahim, Jose Franco-Chaves, Nancy Diazgranados, Anibal Cravchik, Jessica Selter, Craig A Marquardt, Victoria Liberty, David A Luckenbaugh

4 registry-linked trialsAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Biological psychiatry, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 365 papers, 23 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
365citing papers in PubMed, 23 pooled it
64.1field-weighted citation impact, top 1% 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.

NCT01935115 phase4completednot on this mapstarted 2013, after this paper: background citation

A Prospective Randomized Double Blinded Control Trial Using Ketamine or Propofol Anesthesia for Electroconvulsive Therapy: Improving Treatment-Resistant Depression

TypeinterventionalSponsorUniversity of SaskatchewanRan2013 to 2016Enrolled27ConditionsTreatment Resistant DepressionArmsPropofol, Ketamine
NCT02610712 phase4unknown statusnot on this mapstarted 2014, after this paper: background citation

Clinical Trial of the Use of Ketamine in Treatment Resistant Depression

TypeinterventionalSponsorNational Institute of Neurology and Neurosurgery, MexicoRan2014Enrolled20ConditionsDepressive Disorder, Treatment-ResistantArmsKetamine
NCT03502551 phase2withdrawnnot on this mapstarted 2019, after this paper: background citation

ED Treatment of Suicidal Patients With Ketamine Infusion

TypeinterventionalSponsorUniversity of California, DavisRan2019 to 2019Enrolled0ConditionsSuicide, Suicidal IdeationArmsKetamine
NCT03742557 phase3unknown statusnot on this mapstarted 2018, after this paper: background citation

Evaluation of Schemes of Administration of Intravenous Ketamine in Treatment-resistant Depression: Clinical-neuroimaging Correlation

TypeinterventionalSponsorNational Institute of Neurology and Neurosurgery, MexicoRan2018 to 2020Enrolled30ConditionsTreatment Resistant DepressionArmsKetamine 50 MG/ML Injectable Solution, 0.5 mg/kg IV
3 · Its place in the literature

Who cites it

365 citing papers in PubMed, 23 syntheses or guidelines pooled it, 806 citations in OpenAlex.

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  7. Ketamine treatment for refractory anxiety: A systematic review.British journal of clinical pharmacology · 2022
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  15. Ketamine for Bipolar Depression: A Systematic Review.The international journal of neuropsychopharmacology · 2021
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  20. Pharmacological Augmentation in Unipolar Depression: A Guide to the Guidelines.The international journal of neuropsychopharmacology · 2020
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305 more citing papers are in PubMed but not listed here.

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

10 authors at 3 institutions in 2 countries.

Carlos A ZarateExperimental Therapeutics & Pathophysiology Branch, Intramural Research Program, National Institute of Mental Health, National Institutes of Health, and Department of Health and Human Services, Bethesda, Maryland, USA. zaratec@mail.nih.gov
Nancy E Brutsche
Lobna Ibrahim
Jose Franco-Chaves
Nancy Diazgranados
Anibal Cravchik
Jessica Selter
Craig A Marquardt
Victoria Liberty
David A Luckenbaugh
National Institutes of Health · USNational Institute of Mental Health · USNational Institute of Mental Health · CZ

Funding

Glutamatergic Modulators for Rapid & Sustained Antidepressant EffectZIAMH002857 · NIMH · NATIONAL INSTITUTE OF MENTAL HEALTH · PI ZARATE, CARLOS · 2009 to 2025
$55.0M
Intramural NIH HHS ZIA MH002857
6 · The paper itself

Abstract

backgroundCurrently, no pharmacological treatments for bipolar depression exist that exert rapid (within hours) antidepressant or antisuicidal effects. We previously reported that intravenous administration of the N-methyl-D-aspartate antagonist ketamine produced rapid antidepressant effects in patients with treatment-resistant bipolar depression. The present study sought to replicate this finding in an independent sample.

methodsIn this double-blind, randomized, crossover, placebo-controlled study, 15 subjects with DSM-IV bipolar I or II depression maintained on therapeutic levels of lithium or valproate received a single intravenous infusion of either ketamine hydrochloride (.5 mg/kg) or placebo on 2 test days 2 weeks apart. The primary outcome measure was the Montgomery-Asberg Depression Rating Scale, which was used to rate overall depressive symptoms at baseline; at 40, 80, 110, and 230 minutes postinfusion; and on days 1, 2, 3, 7, 10, and 14 postinfusion.

resultsWithin 40 minutes, depressive symptoms, as well as suicidal ideation, significantly improved in subjects receiving ketamine compared with placebo (d = .89, 95% confidence interval = .61-1.16, and .98, 95% confidence interval = .64-1.33, respectively); this improvement remained significant through day 3. Seventy-nine percent of subjects responded to ketamine and 0% responded to placebo at some point during the trial. The most common side effect was dissociative symptoms, which occurred only at the 40-minute time point.

conclusionsThis study replicated our previous finding that patients with bipolar depression who received a single ketamine infusion experienced a rapid and robust antidepressant response. In addition, we found that ketamine rapidly improved suicidal ideation in these patients.

Indexed as

Suicidal IdeationAdultBipolar DisorderCross-Over StudiesDepressionDouble-Blind MethodExcitatory Amino Acid AntagonistsFemaleHumansInfusions, IntravenousKetamineMaleMiddle AgedTreatment OutcomeExcitatory Amino Acid AntagonistsKetamine

Identifiers

PMID22297150
PMCPMC3343177
OpenAlexW2157040702

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.