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Subanalysis of Subjective Cognitive Measures From a Phase 2, Double-Blind, Randomized Trial of REL-1017 in Patients With Major Depressive Disorder
Open accessAbstract
Objective: Improvement of cognitive function in patients with major depressive disorder (MDD) is an important treatment outcome. REL-1017 (esmethadone HCl) is a novel N-methyl-d-aspartate receptor (NMDAR) channel blocker and a potentially rapidly acting antidepressant. The objective of this study was to define the effects of REL-1017 on subjective cognitive measures in patients with MDD. Methods: Post hoc analysis was conducted of subjective cognitive measures from the Montgomery-Asberg Depression Rating Scale (MADRS) and the Symptoms of Depression Questionnaire (SDQ) from a randomized, double-blind, placebo-controlled, Phase 2a study. The study, designed to assess the safety, tolerability, and efficacy of 2 dosages (25 mg and 50 mg) of REL-1017 as an adjunctive treatment in patients with MDD unresponsive to standard antidepressants, included 62 patients. We analyzed subjective cognitive measures derived from the MADRS and SDQ scales at baseline and up to day 14, 7 days after the last dose of study drug. We developed 2 composite indexes that included subjective cognitive measures selected from the MADRS and SDQ. Results: The subanalysis of single measures and the 2 composite indexes derived from the MADRS and SDQ measures showed clinically meaningful and statistically significant improvements in cognitive function (P < .05). Conclusions: In a Phase 2a clinical trial, REL-1017 improved subjective measures of cognitive impairment, in addition to improving total MADRS and SDQ scores. These results need to be confirmed in larger and longer studies in MDD that include objective measures of cognitive function. Phase 3 studies of REL-1017 for MDD are currently underway. Clinical Trials Registration: ClinicalTrials.gov identifier: NCT03051256
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A sub-analysis from the phase II study accessing subjective cognitive measures from both MADRS and SDQ showed improvement in cognitive functions in the groups that received d-methadone compared to placebo in 14 days of evaluation.
“Results from a sub-analysis made from the phase II study accessing subjective cognitive measures from both MADRS and SDQ showed improvement in cognitive functions in the groups that received the drug compared to placebo in 14 days of evaluation [135].”
From Pharmacotherapies Targeting GABA-Glutamate Neurotransmission for Treatment-Resistant Depression (2023) · cites this paper as [135]
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- Vos T, Barber RM, Bell B, et al; Global Burden of Disease Study 2013 Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 301 acute and chronic diseases and injuries in 188 countries, 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2015;386(9995):743-800.
- Pochwat B, Pałucha-Poniewiera A, Szewczyk B, et al. NMDA antagonists under investigation for the treatment of major depressive disorder. Expert Opin Investig Drugs. 2014;23(9):1181-1192.
- Bernstein G, Davis K, Mills C, et al. Characterization of the safety and pharmacokinetic profile of D -methadone, a novel N-methyl-D-aspartate receptor antagonist in healthy, opioid-naïve subjects: results of two phase 1 studies. J Clin Psychopharmacol. 2019;39(3):226-237.
- Fava M, Mahableshwarkar AR, Jacobson W, et al. What is the overlap between subjective and objective cognitive impairments in MDD? Ann Clin Psychiatry. 2018;30(3):176-184.
- Fava M, Graves LM, Benazzi F, et al. A cross- sectional study of the prevalence of cognitive and physical symptoms during long-term antidepressant treatment. J Clin Psychiatry. 2006;67(11):1754-1759.
- Popovic D, Vieta E, Fornaro M, et al. Cognitive tolerability following successful long term treatment of major depression and anxiety disorders with SSRi antidepressants. J Affect Disord. 2015;173:211-215.
- Raskin J, Wiltse CG, Siegal A, et al. Efficacy of duloxetine on cognition, depression, and pain in elderly patients with major depressive disorder: an 8-week, double-blind, placebo- controlled trial. Am J Psychiatry. 2007;164(6):900-909.
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Pharmacotherapies Targeting GABA-Glutamate Neurotransmission for Treatment-Resistant Depression
Vecera, C. M., C. Courtes, A., Jones, G., Soares, J. C., & Machado-Vieira, R. (2023) · Pharmaceuticals · doi:10.3390/ph16111572 · Cited by 48
“Results from a sub-analysis made from the phase II study accessing subjective cognitive measures from both MADRS and SDQ showed improvement in cognitive functions in the groups that received the drug compared to placebo in 14 days of evaluation [135].”
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Metadata
- Authors
- Guidetti, C., Serra, G., Pani, L., Pappagallo, M., Maglio, G., Martin, S. D., Mattarei, A., Folli, F., Manfredi, P. L., & Fava, M.
- Affiliations
- Bambino Gesù Children's Hospital (IT)
- University of Miami (US)
- Albert Einstein College of Medicine (US)
- University of Padua (IT)
- University of Milan (IT)
- Relmada Therapeutics, Inc. (United States) (US)
- Corresponding author
- Manfredi, Paolo L.
- ORCID
- Venue
- The Primary Care Companion For CNS Disorders
- Publisher
- Physicians Postgraduate Press, Inc
- Published
- 2023-02-14
- Volume
- 25
- Issue
- 1
- ISSN
- 2155-7772 (ISSN-L)
- 2155-7780
- OpenAlex
- W4320482167
- Cited by
- 4
- References
- 0
- Citations by year
- 2024: 1 · 2023: 3
- FWCI
- 0.62
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- The Primary Care Companion For CNS Disorders (publishedVersion)
- PubMed (publishedVersion)
- IRIS UNIMORE (University of Modena and Reggio Emilia) (submittedVersion)
- Padua Research Archive (University of Padova) (submittedVersion)
- Topics
- Health Sciences › Medicine › Pharmacology (medical) › Treatment of Major Depression
- Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
- Life Sciences › Neuroscience › Biological Psychiatry › Tryptophan and brain disorders
- Keywords
- major depressive disorder, NMDA receptor antagonists, cognitive impairment, rapid-acting antidepressants
- MeSH terms
- Antidepressive Agents, Cognition, Depression, Major Depressive Disorder, Depressive Disorder, Major, Double-Blind Method, Humans, Treatment Outcome
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