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• W2557291238 abstract "Background: Therapies targeting the glutamatergic system are known to be efficacious in the treatment of mood disorders. Antagonism of the post-synaptic mGlu5 receptor is a novel approach to indirectly modulate glutamatergic (NMDA) function and has shown efficacy in a number of preclinical behavioral models of depression. Basimglurant is a potent and selective negative allosteric modulator of the mGlu5 receptor which has been comprehensively profiled in Ph1 and Ph2a trials. The main objectives of this Ph2b trial were to evaluate the safety and efficacy of basimglurant modified release (MR) vs. placebo, as adjunctive therapy to ongoing antidepressant treatment in patients with major depressive disorder (MDD) who showed inadequate response to at least one but no more than three treatment failures within the current episode. Methods: In this 9-week study (6-week double-blind treatment, 3-week post-treatment follow- up), adult patients with DSM-IV-TR diagnosis of MDD were randomized to basimglurant 0.5 mg/d, 1.5 mg/d, or placebo (adjunctive to ongoing SSRI or SNRI). The primary endpoint was the mean change from baseline in the Montgomery-Asberg Depression Rating Scale Sigma total score (MADRS), as rated by the clinician at week 6. Concomitantly, patient-rated MADRS scores were also collected and analyzed. Secondary endpoints included change in the Quick Inventory of Depressive Symptomatology (QIDS-SR16), MADRS response (≥ 50% reduction in score from baseline), MADRS remission (score of ≤ 10), and Clinician and Patient Global Impression scales (CGI-I, PGI-I and CGI-S). Exploratory endpoints included change in the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) and the Sheehan Disability Scale (SDS). Due to the exploratory nature of this study, one-sided p values were estimated with no adjustment for multiplicity. Completers (observed cases) ANCOVA and ITT MMRM statistical analysis were performed. Results: 333 male and female patients were randomized in to the study. The primary endpoint for the study (clinician-rated MADRS) was not met (p=0.127 ITT MMRM analysis); a trend for improvement was observed for basimglurant 1.5 mg vs. placebo (p=0.061 completers ANCOVA analysis) while statistical significance was reached utilizing the patient-rated MADRS (p<0.025 in both analyses). Regarding the secondary endpoints basimglurant 1.5 mg showed significant improvements vs. placebo in QIDS mean change from baseline (p=0.004 in both analyses), CGI-I mean score (p<0.039 in both analyses), PGI-I mean score (p<0.029 in both analyses). Significant improvements were also seen with in the patient-rated MADRS remission rate (p<0.024 both analyses), and to a lesser degree in the patient-rated MADRS response (p<0.1 both analyses). Lastly, significant improvements were observed in the Q-LES- Q-SF (p=0.011) and the SDS items 2-3 (p=0.047) (ITT MMRM). Basimglurant dosed at 0.5 mg showed no benefit over placebo in any of these measures. Withdrawal rates due to adverse events were 5.4%, 7.2% and 4.5% for basimglurant 0.5 mg, 1.5 mg, and placebo, respectively." @default.
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• W2557291238 date "2015-01-01" @default.
• W2557291238 modified "2023-09-23" @default.
• W2557291238 title "T1. THE ANTIDEPRESSANT ACTIVITY OF BASIMGLURANT, A NOVEL MGLU5-NAM; A RANDOMIZED, DOUBLE-BLIND, PLACEBO- CONTROLLED STUDY IN THE ADJUNCTIVE TREATMENT OF MDD" @default.
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