Mavoglurant Augmentation in OCD Patients Resistant to Selective Serotonin Reuptake Inhibitors: A Proof-of-Concept, Randomized, Placebo-Controlled, Phase 2 Study.

Rutrick, Daniel; Stein, Dan J; Subramanian, Ganesan; Smith, Brian; Fava, Maurizio; Hasler, Gregor; Cha, Jang-Ho; Gasparini, Fabrizio; Donchev, Toni; Ocwieja, Magdalena; Johns, Donald; Gomez-Mancilla, Baltazar (2017). Mavoglurant Augmentation in OCD Patients Resistant to Selective Serotonin Reuptake Inhibitors: A Proof-of-Concept, Randomized, Placebo-Controlled, Phase 2 Study. Advances in therapy, 34(2), pp. 524-541. Springer 10.1007/s12325-016-0468-5

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INTRODUCTION To determine if mavoglurant (modified release) as an augmentation therapy to selective serotonin reuptake inhibitors (SSRIs) could have beneficial effects 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. Patients remained on their SSRI treatment and mavoglurant or placebo was added on. Non-smoking men and women aged 18-65 years primarily diagnosed with OCD according to 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 determine whether the study should be continued. 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. In total 38 (76.0%) participants completed 17 weeks of treatment and 37 (74.0%) completed the study. There was no significant difference in least squares (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 = 0.671]. The incidence of AEs was higher in the mavoglurant compared with the placebo group (80.8% vs. 70.8%, respectively). CONCLUSION This study of mavoglurant in OCD was terminated because of the lack of efficacy at interim analysis. The study did not support the use of an antagonist of mGluR5 receptors for OCD treatment. TRIAL REGISTRATION The study was registered with ClinicalTrials.gov: NCT01813019. FUNDING This study was sponsored by Novartis Pharma AG, Basel, Switzerland.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > University Psychiatric Services > University Hospital of Psychiatry and Psychotherapy > Translational Research Center
04 Faculty of Medicine > University Psychiatric Services > University Hospital of Psychiatry and Psychotherapy
04 Faculty of Medicine > University Psychiatric Services > University Hospital of Psychiatry and Psychotherapy > Healthcare Research

UniBE Contributor:

Hasler, Gregor

Subjects:

600 Technology > 610 Medicine & health

ISSN:

0741-238X

Publisher:

Springer

Language:

English

Submitter:

Gregor Hasler

Date Deposited:

23 Feb 2017 16:01

Last Modified:

03 Mar 2017 01:30

Publisher DOI:

10.1007/s12325-016-0468-5

PubMed ID:

28044255

Uncontrolled Keywords:

AFQ056; Glutamate; Mavoglurant; Obsessive–compulsive disorder; Psychiatry; Randomized controlled trial; Selective serotonin reuptake inhibitors

BORIS DOI:

10.7892/boris.92555

URI:

https://boris.unibe.ch/id/eprint/92555

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