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

Autor: Toni Donchev, Baltazar Gomez-Mancilla, Gregor Hasler, Dan J. Stein, Maurizio Fava, Magdalena Ocwieja, Donald Johns, Daniel Rutrick, Brian Smith, Jang-Ho Cha, Ganesan Subramanian, Fabrizio Gasparini
Rok vydání: 2017
Předmět:
Adult
Male
Obsessive-Compulsive Disorder
medicine.medical_specialty
Indoles
Receptor
Metabotropic Glutamate 5
Drug Resistance
Phases of clinical research
Placebo
law.invention
03 medical and health sciences
chemistry.chemical_compound
0302 clinical medicine
Double-Blind Method
Randomized controlled trial
law
Internal medicine
Humans
Medicine
Mavoglurant
Pharmacology (medical)
Adverse effect
Psychiatric Status Rating Scales
Psychotropic Drugs
business.industry
Incidence (epidemiology)
Drug Synergism
General Medicine
Middle Aged
Interim analysis
Rheumatology
030227 psychiatry
Diagnostic and Statistical Manual of Mental Disorders
Treatment Outcome
chemistry
Delayed-Action Preparations
Anesthesia
Early Termination of Clinical Trials
Drug Therapy
Combination
Female
business
Selective Serotonin Reuptake Inhibitors
030217 neurology & neurosurgery
Zdroj: Advances in Therapy. 34:524-541
ISSN: 1865-8652
0741-238X
DOI: 10.1007/s12325-016-0468-5
Popis: 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. 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). 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). 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. The study was registered with ClinicalTrials.gov: NCT01813019. This study was sponsored by Novartis Pharma AG, Basel, Switzerland.
Databáze: OpenAIRE
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