Efficacy and Safety of Vilazodone in Patients With Generalized Anxiety Disorder
| Autor: | Suresh Durgam, David V. Sheehan, Giovanna Forero, Xiongwen Tang, Rene Nunez, Carl Gommoll, Maju Mathews |
|---|---|
| Rok vydání: | 2016 |
| Předmět: |
Adult
medicine.medical_specialty Generalized anxiety disorder Hamilton Anxiety Rating Scale Vilazodone Hydrochloride Population Placebo law.invention 03 medical and health sciences chemistry.chemical_compound Serotonin Agents 0302 clinical medicine Double-Blind Method Randomized controlled trial law Internal medicine Outcome Assessment Health Care Vilazodone medicine Humans HARS education Psychiatry education.field_of_study business.industry Middle Aged medicine.disease Anxiety Disorders 030227 psychiatry Psychiatry and Mental health Anti-Anxiety Agents chemistry Tolerability business 030217 neurology & neurosurgery |
| Zdroj: | The Journal of Clinical Psychiatry. 77:1687-1694 |
| ISSN: | 0160-6689 |
| DOI: | 10.4088/jcp.15m09885 |
| Popis: | Objective To evaluate the efficacy, safety, and tolerability of vilazodone as an acute treatment for generalized anxiety disorder (GAD). Vilazodone is a selective serotonin reuptake inhibitor and 5-HT1A receptor partial agonist approved for the treatment of major depressive disorder in adults. Methods This was a randomized, placebo-controlled, parallel-group, multicenter, flexible-dose study conducted from May 2013-March 2014. Adult patients (18-70 years, inclusive) who met DSM-IV-TR criteria for GAD were randomized (1:1) to placebo or vilazodone 20-40 mg/d for 8 weeks of double-blind treatment. Primary and secondary efficacy parameters were change from baseline to week 8 in the Hamilton Anxiety Rating Scale (HARS) total score and in the Sheehan Disability Scale (SDS) total score, respectively, analyzed using a mixed-effects model for repeated measures approach on a modified intent-to-treat population. Safety outcomes were summarized descriptively. Results Efficacy analyses were based on 400 patients (placebo = 200, vilazodone = 200); 76% completed the study (placebo = 81%, vilazodone = 71%). The least squares mean difference (95% CI) in total score change from baseline to week 8 was statistically significant for vilazodone versus placebo on the HARS (-2.20 [-3.72 to -0.68]; P = .0048) and on the SDS (-1.89 [-3.52 to -0.26]; P = .0236). Treatment-emergent adverse events reported in ≥ 5% of vilazodone patients and at least twice the rate of placebo were nausea, diarrhea, dizziness, fatigue, delayed ejaculation, and erectile dysfunction. Conclusion Statistically significant differences in favor of vilazodone 20-40 mg/d versus placebo were seen on all measures of anxiety and functional impairment in patients with GAD. Vilazodone was generally well tolerated, and no new safety concerns were noted. Trial registration ClinicalTrials.gov identifier: NCT01844115. |
| Databáze: | OpenAIRE |
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