Duloxetine in the treatment of major depressive disorder: an open-label study

Hudson, James I.; Perahia, David G.; Gilaberte, Inmaculada; Fujun Wang; Watkin, John G.; Detke, Michael J.
January 2007
BMC Psychiatry;2007, Vol. 7, p43
Academic Journal
Background: Major depressive disorder (MDD) is a chronic and highly disabling condition. Existing pharmacotherapies produce full remission in only 30% to 40% of treated patients. Antidepressants exhibiting dual reuptake inhibition of both serotonin (5-HT) and norepinephrine (NE) may achieve higher rates of remission compared with those acting upon a single neurotransmitter. In this study, the safety and efficacy of duloxetine, a potent dual reuptake inhibitor of 5-HT and NE, were examined. 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 ≥18 and a Clinical Global Impression of Severity (CGI-S) score ≥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 ≥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: In this open-label phase of a relapse prevention study, duloxetine (60 mg QD) was shown to be safe and effective in the treatment of MDD.


Related Articles

  • Still Struggling: Characteristics of Youth With OCD Who are Partial Responders to Medication Treatment. Freeman, J.; Sapyta, J.; Garcia, A.; Fitzgerald, D.; Khanna, M.; Choate-Summers, M.; Moore, P.; Chrisman, A.; Haff, N.; Naeem, A.; March, J.; Franklin, M. // Child Psychiatry & Human Development;Aug2011, Vol. 42 Issue 4, p424 

    The primary aim of this paper is to examine the characteristics of a large sample of youth with OCD who are partial responders (i.e., still have clinically significant symptoms) to serotonin reuptake inhibitor (SRI) medication. The sample will be described with regard to: demographics, treatment...

  • Discontinuation rates of SSRIs and tricyclic antidepressants: a meta-analysis and investigation of heterogeneity. Hotopf, Matthew; Hardy, Rebecca; Lewis, Glyn; Hotopf, M; Hardy, R; Lewis, G // British Journal of Psychiatry;Feb97, Vol. 170, p120 

    Background: Previous meta-analyses suggest that individuals treated with serotonin-specific reuptake inhibitors (SSRIs) in randomised controlled trials (RCTs) are less likely to discontinue treatment than those on tricyclic antidepressants. This metaanalysis investigates whether...

  • sertraline.  // Davis's Drug Guide for Nurses, 10th edition;2007, p1070 

    The article presents information on sertraline, a selective serotonin reuptake inhibitor used in the management of depression, panic disorder, obsessive-compulsive disorder, post-traumatic stress disorder, social anxiety disorder and premenstrual dysphoric disorder. Some of its side effects...

  • Simultaneous analyses of the neurochemical and behavioral effects of the norepinephrine reuptake inhibitor reboxetine in a rat model of antidepressant action. Page, Michelle E.; Brown, Kevin; Lucki, Irwin // Psychopharmacology;2003, Vol. 165 Issue 2, p194 

    Investigates the simultaneous neurochemical and behavioral effects of the norepinephrine reuptake inhibitor reboxetine in a rat model of antidepressant action. Noradrenergic responses; Neurotransmitter levels and behavior; Precipitation of depressive symptomatology.

  • Safety of 5-HT reuptake inhibitors. Harrison, Debbie; Harrison, D // British Journal of Psychiatry;Jun92, Vol. 160, p866 

    A letter to the editor is presented in response to a letter about the safety of 5-HT reuptake inhibitors.

  • In this issue.  // Journal of Palliative Medicine;Feb2006, Vol. 9 Issue 1, p1 

    The article discusses various reports published within the issue, including one about dulexitine, a dual reuptake inhibitor of both serotonin and norepinephrine for the neuropathic pain of diabetes and the other about the reduction of the potency of prescribed opioid analgesia when patients are...

  • Crane remote controller.  // Manufacturers' Monthly;Sep2009, p51 

    The article evaluates the Remotus MB-28 transmitter from Akerstroms.

  • GABA Uptake Inhibitors. Design, Molecular Pharmacology and Therapeutic Aspects. Krogsgaard-Larsen, Povl; Frolund, Bente; Frydenvang, Karla // Current Pharmaceutical Design;Aug2000, Vol. 6 Issue 12, p1193 

    In the mid seventies a drug design programme using the Amanita muscaria constituent muscimol (7) as a lead structure, led to the design of guvacine (23) and (R)-nipecotic acid (24) as specific GABA uptake inhibitors and the isomeric compounds isoguvacine (10) and isonipecotic acid (11) as...

  • Behavioral stimulation without alteration of β and 5-HT receptors and adenylate cyclase activity in rat brain after chronic sertraline administration. Tadokoro, C.; Kiuchi, Y.; Yamazaki, Y.; Nara, K.; Oguchi, K.; Kamijima, K. // Psychopharmacology;1997, Vol. 130 Issue 2, p124 

    Abstract Effects of chronic treatment with selective 5-HT reuptake inhibitors (SSRIs) on the monoaminergic functions have not been much investigated in compared with tricyclic antidepressants. Therefore, we compared the effects of 3-week treatment with sertraline, a potent SSRI, to those of...


Read the Article


Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics