Abstract | BACKGROUND: METHODS: Patients (N = 533) meeting DSM-IV criteria for MDD received open-label duloxetine (60 mg once a day [QD]) for 12 weeks during the initial phase of a relapse prevention trial. Patients were required to have a 17-item Hamilton Rating Scale for Depression (HAMD17) total score >or=18 and a Clinical Global Impression of Severity (CGI-S) score >or=4 at baseline. Efficacy measures included the HAMD17 total score, HAMD17 subscales, the CGI-S, the Patient Global Impression of Improvement (PGI-I) scale, Visual Analog Scales (VAS) for pain, and the Symptom Questionnaire, Somatic Subscale (SQ-SS). Quality of life was assessed using the Sheehan Disability Scale (SDS) and the Quality of Life in Depression Scale (QLDS). Safety was evaluated by recording spontaneously-reported treatment-emergent adverse events, changes in vital signs and laboratory analytes, and the Patient Global Impression of Sexual Function (PGI-SF) scale. RESULTS: The rate of discontinuation due to adverse events was 11.3%. Treatment-emergent adverse events reported by >or=10% duloxetine-treated patients were nausea, headache, dry mouth, somnolence, insomnia, and dizziness. Following 12 weeks of open-label duloxetine therapy, significant improvements were observed in all assessed efficacy and quality of life measures. In assessments of depression severity (HAMD17, CGI-S) the magnitude of symptom improvement continued to increase at each study visit, while for painful physical symptoms the onset of improvement was rapid and reached a maximum after 2 to 3 weeks of treatment. CONCLUSION:
|
Authors | James I Hudson, David G Perahia, Inmaculada Gilaberte, Fujun Wang, John G Watkin, Michael J Detke |
Journal | BMC psychiatry
(BMC Psychiatry)
Vol. 7
Pg. 43
(Aug 28 2007)
ISSN: 1471-244X [Electronic] England |
PMID | 17725843
(Publication Type: Clinical Trial, Journal Article, Research Support, Non-U.S. Gov't)
|
Chemical References |
- Serotonin Uptake Inhibitors
- Thiophenes
- Duloxetine Hydrochloride
|
Topics |
- Chronic Disease
- Depressive Disorder, Major
(diagnosis, drug therapy)
- Disability Evaluation
- Duloxetine Hydrochloride
- Humans
- Quality of Life
(psychology)
- Remission Induction
- Selective Serotonin Reuptake Inhibitors
(therapeutic use)
- Severity of Illness Index
- Sexual Dysfunction, Physiological
(chemically induced, diagnosis, epidemiology)
- Surveys and Questionnaires
- Thiophenes
(therapeutic use)
- Treatment Outcome
|