Evidence map›Paper›PMID 31508531›Full record

ArticleContemporary clinical trials communications2019

Bayesian adaptive randomization trial of intravenous ketamine for veterans with late-life, treatment-resistant depression.

Brittany O'Brien, Charles E Green, Rayan Al-Jurdi, Lee Chang, Marijn Lijffijt, Sidra Iqbal, Tabish Iqbal, Alan C Swann, Sanjay J Mathew

Erratum issuedOpen access · goldAbstract read
In one paragraph

Article in Contemporary clinical trials communications, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 9 citations in OpenAlex.

  1. Trial
  2. Neural complexity EEG biomarkers of rapid and post-rapid ketamine effects in late-life treatment-resistant depression: a randomized control trial.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2023
    Trial
  3. Identification of an optimal dose of intravenous ketamine for late-life treatment-resistant depression: a Bayesian adaptive randomization trial.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2022
    Trial
  4. Response-adaptive randomization in clinical trials: from myths to practical considerations.Statistical science : a review journal of the Institute of Mathematical Statistics · 2023
    Article
  5. Article
  6. Does mismatch negativity have utility for NMDA receptor drug development in depression?Revista brasileira de psiquiatria (Sao Paulo, Brazil : 1999)
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 3 institutions in 1 country.

Brittany O'BrienMichael E. DeBakey VA Medical Center, Houston, TX, USA.
Charles E GreenUniversity of Texas Health Science Center, Houston, TX, USA.
Rayan Al-JurdiBaylor College of Medicine, Houston, TX, USA.
Lee ChangMichael E. DeBakey VA Medical Center, Houston, TX, USA.
Marijn LijffijtMichael E. DeBakey VA Medical Center, Houston, TX, USA.
Sidra IqbalMichael E. DeBakey VA Medical Center, Houston, TX, USA.
Tabish IqbalMichael E. DeBakey VA Medical Center, Houston, TX, USA.
Alan C SwannMichael E. DeBakey VA Medical Center, Houston, TX, USA.
Sanjay J MathewMichael E. DeBakey VA Medical Center, Houston, TX, USA.
Michael E. DeBakey VA Medical Center · USBaylor College of Medicine · USThe University of Texas Health Science Center at Houston · US

Funding

Ketamine for Treatment Resistant Late-Life DepressionI01CX001205 · VA · MICHAEL E DEBAKEY VA MEDICAL CENTER · PI MATHEW, SANJAY J · 2016 to 2020
–
CSRD VA I01 CX001205
6 · The paper itself

Abstract

More than eleven million U.S. Veterans are at least 65 years of age, an age group of which almost 20% suffers from clinically significant depressive symptoms. Available pharmacological treatments are suboptimal for patients, including veterans, with late-life depression. Ketamine has emerged as a potentially promising rapid-acting therapy for treatment-resistant depression (TRD). However, few studies have examined the safety, tolerability and efficacy of ketamine therapy for older adults with late-life TRD (LL-TRD). This study uses an adaptive randomization design to test the safety, tolerability, efficacy, and durability of three distinct, single sub-anesthetic doses of intravenous (IV) ketamine versus a single dose of active placebo (midazolam) in older depressed veterans. As the study progresses, Bayesian adaptive randomization recalibrates randomization ratios to allocate more participants to conditions demonstrating greater promise and fewer participants to conditions with less promise. Secondary analyses explore clinical and biological moderating and mediating factors of rapid treatment response. Results are expected to inform both the viability of ketamine treatment and optimal dosing strategies for patients with LL-TRD.

Indexed as

Adaptive designBayesian trial designKetamineLate-life depressionTreatment-resistant depressionVeterans

Identifiers

PMID31508531
PMCPMC6727003
OpenAlexW2969675259

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.