Evidence map›Paper›PMID 31040679›Full record

ArticleNeuropsychiatric disease and treatment2019

Buprenorphine/samidorphan combination for the adjunctive treatment of major depressive disorder: results of a phase III clinical trial (FORWARD-3).

John M Zajecka, Arielle D Stanford, Asli Memisoglu, William F Martin, Sanjeev Pathak

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Neuropsychiatric disease and treatment, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 2 pooled it
2.9field-weighted citation impact, top 10% 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

18 citing papers in PubMed, 2 syntheses or guidelines pooled it, 30 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Results from a long-term open-label extension study of adjunctive buprenorphine/samidorphan combination in patients with major depressive disorder.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2019
    Trial
  6. Trial
  7. Review
  8. Review
  9. Review
  10. Article
  11. Opioid Mechanisms and the Treatment of Depression.Current topics in behavioral neurosciences · 2024
    Review
  12. How should we design future mechanistic and/or efficacy clinical trials?Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2024
    Review
  13. Review
  14. Delta Opioid Receptor-Mediated Antidepressant-Like Effects of Diprenorphine in Mice.The Journal of pharmacology and experimental therapeutics · 2023
    Article
  15. Article
  16. The opioid system in depression.Neuroscience and biobehavioral reviews · 2022
    Review
  17. Review
  18. 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

5 authors at 2 institutions in 1 country.

John M ZajeckaDepartment of Psychiatry, Rush University Medical Center, Chicago, IL, USA, john_zajecka@rush.edu.
Arielle D StanfordDepartment of Clinical Research, Alkermes, Inc., Waltham, MA, USA.
Asli MemisogluDepartment of Biostatistics, Alkermes, Inc., Waltham, MA, USA.
William F MartinClinical Operations, Alkermes, Inc., Waltham, MA, USA.
Sanjeev PathakDepartment of Clinical Research, Alkermes, Inc., Waltham, MA, USA.
Alkermes (United States) · USRush University Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe endogenous opioid system is a fundamental regulator of mood in humans. Previously reported clinical trials have demonstrated the efficacy of the investigational agent buprenorphine/samidorphan (BUP/SAM) combination, an opioid-system modulator, for the adjunctive treatment of major depressive disorder. We present here a third phase III study of different design.

methodsAdult patients with major depressive disorder and inadequate response to antidepressant therapy were enrolled in this double-blind, placebo-controlled, placebo run-in study to evaluate the efficacy, safety, and tolerability of adjunctive BUP/SAM 2 mg/2 mg. Patients with baseline Hamilton Depression Rating Scale score $20 received double-blind placebo in addition to background antidepressant therapy for 4 weeks. Nonresponders were randomized to receive adjunctive BUP/SAM 2 mg/2 mg or placebo for 6 weeks. The primary end point was change in Montgomery-Åsberg Depression Rating Scale (MADRS)-10 total score from randomization at baseline to the end of the 6-week treatment period.

resultsLeast-squares mean change in MADRS-10 score at end of treatment was -4.8 (SE 0.67) in the BUP/SAM 2 mg/2 mg group and -4.6 (SE 0.66) in the placebo group (mean difference -0.3 [SE 0.95],

conclusionEfficacy results in FORWARD-3 measured by change in MADRS-10 score did not meet the primary end point, but postbaseline improvement in MADRS-10 in the BUP/SAM 2 mg/2 mg group was consistent with that seen in previously reported trials. BUP/SAM 2 mg/2 mg was well tolerated.

Indexed as

adjunctive therapybuprenorphineopioid system modulatorplacebo responserandomized clinical trialsamidorphanstudy design

Identifiers

PMID31040679
PMCPMC6459143
OpenAlexW2928380625

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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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.