Evidence map›Paper›PMID 28338546›Full record

Trial reportJournal of clinical psychopharmacology2017

A Double-Blind, Placebo-Controlled, Pilot Study of Riluzole Monotherapy for Acute Bipolar Depression.

Lawrence T Park, Marc S Lener, Matthew Hopkins, Nicolas Iadorola, Rodrigo Machado-Vieira, Elizabeth Ballard, Allison Nugent, Carlos A Zarate

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical psychopharmacology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00054704 (An Investigation of the Antidepressant Efficacy of an Antiglutamatergic Agent in Bipolar Depression), which is not on this map. Cited by 14 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 2 pooled it
3.8field-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.

NCT00054704 phase2terminatednot on this map

An Investigation of the Antidepressant Efficacy of an Antiglutamatergic Agent in Bipolar Depression

TypeinterventionalSponsorNational Institute of Mental Health (NIMH)Ran2003 to 2014Enrolled19ConditionsBipolar DisorderArmsRiluzole, Placebo
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 2 syntheses or guidelines pooled it, 33 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. Article
  6. Article
  7. Review
  8. Intracellular Signaling Cascades in Bipolar Disorder.Current topics in behavioral neurosciences · 2021
    Review
  9. New Pharmacological Interventions in Bipolar Disorder.Current topics in behavioral neurosciences · 2021
    Review
  10. Astrocytes in Bipolar Disorder.Advances in neurobiology · 2021
    Article
  11. Article
  12. Review
  13. Article
  14. 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

8 authors at 1 institution in 2 countries.

Lawrence T ParkFrom the Experimental Therapeutics and Pathophysiology Branch, National Institute of Mental Health, National Institutes of Health, Bethesda, MD.
Marc S Lener
Matthew Hopkins
Nicolas Iadorola
Rodrigo Machado-Vieira
Elizabeth Ballard
Allison Nugent
Carlos A Zarate
National Institute of Mental Health · US

Funding

Glutamatergic Modulators for Rapid & Sustained Antidepressant EffectZIAMH002857 · NIMH · NATIONAL INSTITUTE OF MENTAL HEALTH · PI ZARATE, CARLOS · 2009 to 2025
$55.0M
Target validation of novel therapeutic agents in mood disordersZIAMH002927 · NIMH · NATIONAL INSTITUTE OF MENTAL HEALTH · PI ZARATE, CARLOS · 2010 to 2025
$37.1M
Intramural NIH HHS Z99 MH999999Intramural NIH HHS ZIA MH002927
6 · The paper itself

Abstract

backgroundGlutamatergic system abnormalities are implicated in the pathophysiology and treatment of both major depressive disorder and bipolar depression (BDep). Subsequent to studies demonstrating the rapid and robust antidepressant effects of ketamine, an N-methyl-D-aspartate receptor antagonist, other glutamatergic modulators are now being studied in clinical trials of mood disorders. A previous open-label study found that riluzole, administered in combination with the mood stabilizer lithium, had antidepressant effects.

methodsWe conducted a randomized, double-blind, placebo-controlled trial of riluzole monotherapy for the treatment of BDep. Nineteen subjects aged 18 to 70 years with bipolar disorder currently experiencing a depressive episode were tapered off of excluded medications and randomized to receive riluzole (50-200 mg/d) or placebo for 8 weeks. Rating scale scores (Montgomery-Åsberg Depression Rating Scale, Hamilton Rating Scale for Depression, Hamilton Rating Scale for Anxiety, and Young Mania Rating Scale) were obtained weekly.

resultsNo significant differences in depressive symptoms were observed between subjects treated with riluzole and those receiving placebo (P = 0.12). Anxiety scores were significantly lower in the placebo group (P = 0.046). An interim analysis was conducted that resulted in stopping the study because of futility; no subjects had achieved treatment response.

conclusionsAlthough we found no change in severity of depressive symptoms in BDep patients receiving riluzole compared with placebo, this trial was limited by the relatively high number of subject withdrawals and the small sample size. Thus, while riluzole monotherapy did not demonstrate efficacy for BDep, further studies examining riluzole as adjunctive therapy for this disorder may be warranted.Clinical Trials Identifier NCT00054704.

Indexed as

Treatment FailureAdolescentAdultAgedBipolar DisorderDouble-Blind MethodExcitatory Amino Acid AntagonistsHumansMiddle AgedPilot ProjectsRiluzoleYoung AdultExcitatory Amino Acid AntagonistsRiluzole

Identifiers

PMID28338546
PMCPMC5392145
OpenAlexW2600170301

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.