Efficacy and safety of an adjunctive mGlu2 receptor positive allosteric modulator to a SSRI/SNRI in anxious depression
| Autor: | Pilar Lim, Ceusters Marc Andre, Justine M. Kent, Peter de Boer, Wayne C. Drevets, Ella Daly, Rosanne Lane, Luc Van Nueten, Heidi De Smedt, Iva Kezic |
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| Rok vydání: | 2016 |
| Předmět: |
Adult
Male medicine.medical_specialty Adolescent Pyridones Serotonin reuptake inhibitor Placebo Young Adult 03 medical and health sciences 0302 clinical medicine Double-Blind Method Piperidines Internal medicine medicine Humans Psychiatry Biological Psychiatry Psychiatric Status Rating Scales Pharmacology Dose-Response Relationship Drug STAR*D Depression Middle Aged medicine.disease Antidepressive Agents 030227 psychiatry Treatment Outcome Tolerability Adjunctive treatment Major depressive disorder Anxiety Female medicine.symptom Psychology Somatization Selective Serotonin Reuptake Inhibitors 030217 neurology & neurosurgery |
| Zdroj: | Progress in Neuro-Psychopharmacology and Biological Psychiatry. 67:66-73 |
| ISSN: | 0278-5846 |
| DOI: | 10.1016/j.pnpbp.2016.01.009 |
| Popis: | This phase 2a, randomized, multicenter, double-blind, proof-of-concept study was designed to evaluate, efficacy, safety and tolerability of JNJ-40411813/ADX71149, a novel metabotropic glutamate 2 receptor positive allosteric modulator as an adjunctive treatment for major depressive disorder (MDD) with significant anxiety symptoms. Eligible patients (18-64 years) had a DSM-IV diagnosis of MDD, Hamilton Depression Rating Scale-17 (HDRS17) score of ≥ 18, HDRS17 anxiety/somatization factor score of ≥ 7, and an insufficient response to current treatment with a selective serotonin reuptake inhibitor or serotonin-norepinephrine reuptake inhibitor. The doubly-randomized, 8-week double-blind treatment phase was comprised of two 4-week periods, from which a combined test statistic was generated, with pre-determined weights assigned to each of the 2 treatment periods. Period 1: patients (n=121) were randomly assigned (1:1) to JNJ-40411813 (n=62; 50mg to 150 mg b.i.d, flexibly dosed) or placebo (n=59); Period 2: placebo-treated patients (n=22) who continued to meet entry severity criteria were re-randomized (1:1) to JNJ-40411813 or placebo, while other patients underwent sham re-randomization and continued on their same treatment. Of 121 randomized patients, 100 patients (82.6%) were completers. No efficacy signal was detected on the primary endpoint, the 6-item Hamilton Anxiety Subscale (HAM-A6, p=0.51). Efficacy signals (based on prespecified 1-sided p |
| Databáze: | OpenAIRE |
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