Evidence map›Paper›PMID 27681442›Full record

Trial reportNeuropsychopharmacology : official publication of the American College of Neuropsychopharmacology2017

Adjunctive Lanicemine (AZD6765) in Patients with Major Depressive Disorder and History of Inadequate Response to Antidepressants: A Randomized, Placebo-Controlled Study.

Gerard Sanacora, Michael R Johnson, Arif Khan, Sarah D Atkinson, Robert R Riesenberg, Juan P Schronen, Michael A Burke, John M Zajecka, Luis Barra, Hong-Lin Su and 6 more

Open access · hybridAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 66 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
66citing papers in PubMed, 4 pooled it
12.5field-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.

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

66 citing papers in PubMed, 4 syntheses or guidelines pooled it, 114 citations in OpenAlex.

  1. Pooled it
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  4. Pooled it
  5. Trial
  6. Article
  7. Review
  8. Article
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  13. ThePhilosophical transactions of the Royal Society of London. Series B, Biological sciences · 2024
    Review
  14. Review
  15. Ketamine in neuropsychiatric disorders: an update.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2024
    Review
  16. Article
  17. Article
  18. Review
  19. NMDA Receptor Activation-Dependent Antidepressant-Relevant Behavioral and Synaptic Actions of Ketamine.The Journal of neuroscience : the official journal of the Society for Neuroscience · 2023
    Article
  20. Review

6 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

16 authors at 9 institutions in 3 countries.

Gerard SanacoraYale University School of Medicine, New Haven, CT, USA.
Michael R JohnsonSarkis Clinical Trials, Gainesville, FL, USA.
Arif KhanNorthwest Clinical Research Center, Bellevue, WA, USA and Department of Psychiatry, Duke University School of Medicine, Durham, NC, USA.
Sarah D AtkinsonFinger Lakes Clinical Research, Rochester, NY, USA.
Robert R RiesenbergAtlanta Center for Medical Research, Atlanta, GA, USA.
Juan P SchronenWelgemoed Medical Centre, Cape Town, South Africa.
Michael A BurkeiResearch Atlanta, Decatur, GA, USA.
John M ZajeckaRush University Medical Center, Chicago, IL, USA.
Luis BarraUniversidad de Antofagasta, Antofagasta, Chile.
Hong-Lin SuAstraZeneca Pharmaceuticals LP, Wilmington, DE, and Cambridge, MA, USA.
Joel A PosenerAstraZeneca Pharmaceuticals LP, Wilmington, DE, and Cambridge, MA, USA.
Khanh H BuiAstraZeneca Pharmaceuticals LP, Wilmington, DE, and Cambridge, MA, USA.
Michael C QuirkAstraZeneca Pharmaceuticals LP, Wilmington, DE, and Cambridge, MA, USA.
Timothy M PiserAstraZeneca Pharmaceuticals LP, Wilmington, DE, and Cambridge, MA, USA.
Sanjay J MathewBaylor College of Medicine, Houston and Michael E. Debakey VA Medical Center, Houston, TX, USA.
Sanjeev PathakAstraZeneca Pharmaceuticals LP, Wilmington, DE, and Cambridge, MA, USA.
AstraZeneca (United States) · USBellevue Hospital Center · USHealth & Medical Publishing Group · ZAiResearch Atlanta · USMichael E. DeBakey VA Medical Center · USRush University Medical Center · USUniversity of Antofagasta · CLVA Finger Lakes Healthcare System · 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 TR001863
6 · The paper itself

Abstract

The objective of this study was to investigate the efficacy and safety of adjunctive lanicemine (NMDA channel blocker) in the treatment of major depressive disorder (MDD) over 12 weeks. This phase IIb, randomized, parallel-arm, double-blind, placebo-controlled study was conducted at 49 centers in four countries between December 2011 and August 2013 in 302 patients aged 18-70 years, meeting criteria for single episode or recurrent MDD and with a history of inadequate treatment response. Patients were required to be taking an allowed antidepressant for at least four weeks prior to screening. Patients were randomized equally to receive 15 double-blind intravenous infusions of adjunctive lanicemine 50 mg, lanicemine 100 mg, or saline over a 12-week course, in addition to ongoing antidepressant. The primary efficacy end point was change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline to week 6. Secondary efficacy outcome variables included change in MADRS score from baseline to week 12, response and remission rates, and changes in Clinical Global Impression scale, Quick Inventory of Depressive Symptomology Self-Report score, and Sheehan Disability Scale score. Of 302 randomized patients, 240 (79.5%) completed treatment. Although lanicemine was generally well tolerated, neither dose was superior to placebo in reducing depressive symptoms on the primary end point or any secondary measures. There was no significant difference between lanicemine and placebo treatment on any outcome measures related to MDD. Post hoc analyses were performed to explore the possible effects of trial design and patient characteristics in accounting for the contrasting results with a previously reported trial.

Indexed as

Outcome Assessment, Health CareAdultAntidepressive AgentsDepressive Disorder, Treatment-ResistantDouble-Blind MethodDrug Therapy, CombinationFemaleHumansMajor Depressive DisorderMaleMiddle AgedPhenethylaminesPyridinesAntidepressive AgentsAZD6765PhenethylaminesPyridines

Identifiers

PMID27681442
PMCPMC5312066
OpenAlexW2523939934

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.