Evidence map›Paper›PMID 31400624›Full record

Trial reportJournal of affective disorders2019

Longer-term open-label study of adjunctive riluzole in treatment-resistant depression.

Hitoshi Sakurai, Christina Dording, Albert Yeung, Simmie Foster, Felipe Jain, Trina Chang, Nhi-Ha Trinh, Richard Bernard, Sean Boyden, Syed Z Iqbal and 5 more

Open access · greenAbstract readClinical Trial
In one paragraph

Trial report in Journal of affective disorders, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
1.3field-weighted citation impact, top 23% 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

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 21 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. Article
  5. Review
  6. Astrocytes in Bipolar Disorder.Advances in neurobiology · 2021
    Article
  7. Review
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  9. Article
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

15 authors at 4 institutions in 2 countries.

Hitoshi SakuraiDepression Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, 1 Bowdoin Square, 6th Floor, Boston, MA, USA; Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.
Christina DordingDepression Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, 1 Bowdoin Square, 6th Floor, Boston, MA, USA.
Albert YeungDepression Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, 1 Bowdoin Square, 6th Floor, Boston, MA, USA.
Simmie FosterDepression Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, 1 Bowdoin Square, 6th Floor, Boston, MA, USA.
Felipe JainDepression Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, 1 Bowdoin Square, 6th Floor, Boston, MA, USA.
Trina ChangDepression Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, 1 Bowdoin Square, 6th Floor, Boston, MA, USA.
Nhi-Ha TrinhDepression Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, 1 Bowdoin Square, 6th Floor, Boston, MA, USA.
Richard BernardDepression Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, 1 Bowdoin Square, 6th Floor, Boston, MA, USA.
Sean BoydenDepression Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, 1 Bowdoin Square, 6th Floor, Boston, MA, USA.
Syed Z IqbalMental Health Care Line, Michael E. DeBakey VA Medical Center, Houston, TX, USA; Menninger Department of Psychiatry & Behavioral Sciences, Baylor College of Medicine, Houston, TX, USA.
Samuel T WilkinsonDepartment of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.
Sanjay J MathewMental Health Care Line, Michael E. DeBakey VA Medical Center, Houston, TX, USA; Menninger Department of Psychiatry & Behavioral Sciences, Baylor College of Medicine, Houston, TX, USA.
David MischoulonDepression Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, 1 Bowdoin Square, 6th Floor, Boston, MA, USA.
Maurizio FavaDepression Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, 1 Bowdoin Square, 6th Floor, Boston, MA, USA.
Cristina CusinDepression Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, 1 Bowdoin Square, 6th Floor, Boston, MA, USA. Electronic address: ccusin@mgh.harvard.edu.
Massachusetts General Hospital · USBaylor College of Medicine · USMichael E. DeBakey VA 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
Yale-CORE Career Development Program in Patient-Centered Outcomes ResearchK12HS023000 · AHRQ · YALE UNIVERSITY · PI KRUMHOLZ, HARLAN MARC · 2014 to 2018
$3.4M
1/3-Efficacy and Tolerability of Riluzole in Treatment-Resistant DepressionR01MH085055 · NIMH · YALE UNIVERSITY · PI SANACORA, GERARD · 2010 to 2013
$1.5M
3/3-Efficacy and Tolerability of Riluzole in Treatment-Resistant DepressionR01MH085050 · NIMH · MASSACHUSETTS GENERAL HOSPITAL · PI FAVA, MAURIZIO · 2010 to 2013
$1.2M
2/3-Efficacy and Tolerability of Riluzole in Treatment-Resistant DepressionR01MH085054 · NIMH · BAYLOR COLLEGE OF MEDICINE · PI MATHEW, SANJAY J · 2010 to 2013
$991k
AHRQ HHS K12 HS023000NCATS NIH HHS UL1 TR001863NIMH NIH HHS R01 MH085050NIMH NIH HHS R01 MH085054NIMH NIH HHS R01 MH085055
6 · The paper itself

Abstract

backgroundWhile riluzole has been investigated for the treatment of depression, little is known about its longer-term efficacy and optimal treatment duration in treatment-resistant depression (TRD). The objective of this study is to characterize the longer-term outcome of adjunctive riluzole therapy for TRD in an open-label extension of an 8-week acute treatment trial.

methodsThe data from 66 patients with TRD who received adjunctive riluzole in a 12-week open-label extension phase were analyzed. Response rates (⩾50% reduction in the Mongomery-Asberg Depression Rating Scale [MADRS] score), relapse rates (a MADRS score of ⩾22 in patients who had previously achieved response), and adverse events were examined in patients who had achieved response at the end of the acute phase and those who had not.

resultsAmong acute phase responders, the maintained response rate was 66.7% (8/12) and the relapse rate was 8.3% (1/12). In acute phase non-responders, the response rate was 24.1% (13/54). The most commonly reported adverse event was fatigue (9.1%). Three cases were considered serious adverse events; vomiting (n = 1), shortness of breath (n = 1), and aborted suicide attempt (n = 1). LIMITATIONS: This longer-term study was open-label and uncontrolled. The sample size was relatively small.

conclusionsLonger-term adjunctive riluzole appears relatively well tolerated and beneficial for maintaining previous response. Additionally, approximately one fourth of patients who did not respond to 8-week antidepressant treatment might respond if treated with riluzole for 12 weeks. Those findings warrant further investigation because adjunctive riluzole could represent an option for treatment of depression when standard antidepressants have failed.

Indexed as

Time FactorsAdultAntidepressive AgentsDepressive Disorder, Treatment-ResistantDrug Administration ScheduleFemaleHumansMaleMiddle AgedRiluzoleTreatment OutcomeAntidepressive AgentsRiluzoleLonger-termRelapseResponseRiluzoleTolerabilityTreatment-resistant depression

Identifiers

PMID31400624
PMCPMC6710149
OpenAlexW2954845150

What OpenQuestion holds

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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.