Efficacy and Safety of Prolonged-Release Trazodone in Major Depressive Disorder: A Multicenter, Randomized, Double-Blind, Flexible-Dose Trial
| Autor: | Ke-Rang Zhang, Hong-Bo Zheng, Li-Jun Cui, Le-Hua Li, Wei-Wei Xie, Jianguo Shi, Qingrong Tan, Jing-Ping Zhao, Honggeng Zhang, Da-Chun Chen, Gang Wang, Yi Cao, Lin Zhang, Zao-Huo Cheng, Xiu-Feng Xu |
|---|---|
| Rok vydání: | 2014 |
| Předmět: |
Adult
Male medicine.medical_specialty MEDLINE Placebo-controlled study behavioral disciplines and activities law.invention Double blind Double-Blind Method Randomized controlled trial Prolonged release law Internal medicine mental disorders medicine Humans Psychiatry Pharmacology Depressive Disorder Major business.industry Trazodone General Medicine Middle Aged medicine.disease Treatment Outcome Multicenter study Delayed-Action Preparations Antidepressive Agents Second-Generation Major depressive disorder Female business medicine.drug |
| Zdroj: | Pharmacology. 94:199-206 |
| ISSN: | 1423-0313 0031-7012 |
| Popis: | Objective: To investigate the efficacy, safety, and clinical benefit of prolonged-release trazodone (Trittico) in the treatment of major depressive disorder (MDD). Methods: In this study, 363 Chinese patients with MDD were randomized 1:1 to receive either prolonged-release trazodone (150-450 mg) or placebo treatment for 6 weeks. The primary efficacy measurement was the change of the 17-item Hamilton Depression Rating Scale (HAMD-17) total score from baseline to the end of the study. The secondary efficacy measurements were the response and remission rates, the Clinical Global Impression - Improvement of Illness (CGI-I) score at the end of the study, and the change of the HAMD-14 total score and quality of sleep [evaluated by the Pittsburgh Sleep Quality Index (PSQI) scale] during the study period. Results: The mean maximum daily dose was 273.11 mg for the trazodone group and 290.92 mg for the placebo group. At the end of the study, there was a significant difference between the two groups in the HAMD-17 change score (trazodone vs. placebo: -11.07 vs. -8.29, p < 0.001). Trazodone showed advantages at 1 week of treatment, and the effect lasted until the end of the study (week 6). The response and remission rates of the trazodone group were significantly higher than those in the placebo group (response rate: 59.6 vs. 37.2%, p < 0.001; remission rate: 35.5 vs. 22.2%, p = 0.005). The majority of the adverse reactions of trazodone were mild to moderate, and the most frequent adverse reactions (≥5%) were dizziness, dry mouth, somnolence, and nausea. Conclusions: Prolonged-release trazodone was more effective than placebo in MDD and was well tolerated. i 2014 S. Karger AG, Basel |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|