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Mavoglurant in Obsessive-Compulsive Disorder Resistant to Selective Serotonin Reuptake Inhibitor: A Proof-of-Concept, Randomized, Placebo-Controlled, Phase 2 study

Rutrick, Daniel and Stein, Dan and Fava, Maurizio and Hasler, Gregor and Cha, Jang-Ho and Donchev, Toni and Ocwieja, Magdalena and Gomez-Mancilla, Baltazar (2017) Mavoglurant in Obsessive-Compulsive Disorder Resistant to Selective Serotonin Reuptake Inhibitor: A Proof-of-Concept, Randomized, Placebo-Controlled, Phase 2 study. Advances in therapy..

Abstract

This study was conducted to determine if mavoglurant (modified release) as an add-on therapy to selective serotonin reuptake inhibitors (SSRIs) could have beneficial effects by reducing Yale-Brown Obsessive Compulsive Scale (Y-BOCS) total score in patients with obsessive-compulsive disorder (OCD) resistant to SSRI treatment. METHODS: This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase 2 study. Non-smoker men and women aged 18-65 years primarily diagnosed with OCD as per Diagnostic and Statistical Manual of Mental Disorders (4th ed., text rev.; DSM-IV-TR) criteria were randomized (1:1) to mavoglurant or placebo groups. After 50 patients were randomized, an interim analysis was conducted to support the decision concerning the present clinical study or the Sponsor’s clinical development projects. The primary outcome measure was absolute change in Y-BOCS from baseline at Week 17. Safety was assessed by recording adverse events (AEs) and serious adverse events (SAEs). RESULTS: Interim analysis led to a decision to terminate the study. 38(76.0%) participants completed 17 weeks of treatment and 37(74.0%) completed the study. There was no significant difference in LS mean change from baseline at Week 17 in Y-BOCS total score for mavoglurant compared with placebo groups (-6.9[1.75] vs. -8.0[1.78], respectively; LS mean difference: 1.1; 95% CI(-3.9,6.2); p-value: 0.671). The incidence of AEs was higher in the mavoglurant compared with the placebo group (80.8% versus 70.8%, respectively). During the study, six SAEs were reported in three patients (mavoglurant [n=1]; placebo [n=2]). CONCLUSION: The study of mavoglurant in OCD was terminated due to the lack of efficacy at interim analysis. Both mavoglurant and placebo treatment led to a modest reduction in OCD symptom severity in patients who had failed to respond adequately to SSRIs, with no significant difference between the two groups. This study did not support the use of an antagonist of mGluR5 receptors for OCD treatment.

Item Type: Article
Date Deposited: 08 Feb 2017 00:45
Last Modified: 08 Feb 2017 00:45
URI: https://oak.novartis.com/id/eprint/29705

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