PMCCPMCCPMCC

Search tips
Search criteria 

Advanced

 
Logo of jnmaLink to Publisher's site
 
J Natl Med Assoc. 2006 March; 98(3): 437–447.
PMCID: PMC2576123

Duloxetine in the treatment of major depressive disorder: comparisons of safety and efficacy.

Abstract

BACKGROUND: Pooled data from double-blind, placebo-controlled studies were utilized to compare the safety and efficacy of duloxetine in the treatment of major depressive disorder (MDD) in African-American and Caucasian patients. METHODS: Efficacy and safety data were pooled from seven double-blind, placebo-controlled clinical trials of duloxetine. Patients (aged > or =18 years) meeting DSM-IV criteria for MDD received duloxetine (40-120 mg/day; African Americans, N=69; Caucasians, N=748) or placebo (African Americans, N=59; Caucasians, N=594) for up to nine weeks. Efficacy measures included the 17-item Hamilton Rating Scale for Depression (HAMD17) total score, the Clinical Global Impression of Severity (CGI-S) and Patient Global Impression of Improvement (PGI-I) scales, and Visual Analog Scales (VAS) for pain. Safety was assessed using discontinuation rates, spontaneously reported treatment-emergent adverse events, vital signs and laboratory analyses, RESULTS: Based upon mean changes in HAMD17, CGI-S and PGI-I scales, the magnitude of duloxetine's treatment effects did not differ significantly between African-American and Caucasian patients. Discontinuation rates due to adverse events among duloxetine-treated patients were 13.0% for African Americans and 17.0% for Caucasians. No adverse event led to discontinuation in more than one African-American patient. The most common treatment-emergent adverse events in both ethnic groups included nausea, headache, constipation, dizziness and insomnia. The rate of occurrence of these events did not differ significantly between African-American and Caucasian patients. Mean changes from baseline for pulse, blood pressure, weight and laboratory analytes were small and showed no significant differences between African-American and Caucasian patients. CONCLUSION: In this analysis of data from seven clinical trials, no convincing evidence was found to suggest that the overall safety and tolerability profile or the efficacy profile for duloxetine in this cohort of African-American patients differed from that observed in a comparator group of Caucasian patients. The results from these analyses provide supportive evidence for the efficacy and safety of duloxetine in the treatment of MDD in African-American patients.

Full text

Full text is available as a scanned copy of the original print version. Get a printable copy (PDF file) of the complete article (2.1M), or click on a page image below to browse page by page. Links to PubMed are also available for Selected References.

Selected References

These references are in PubMed. This may not be the complete list of references from this article.
  • Blazer DG, Kessler RC, McGonagle KA, Swartz MS. The prevalence and distribution of major depression in a national community sample: the National Comorbidity Survey. Am J Psychiatry. 1994 Jul;151(7):979–986. [PubMed]
  • Jackson-Triche ME, Greer Sullivan J, Wells KB, Rogers W, Camp P, Mazel R. Depression and health-related quality of life in ethnic minorities seeking care in general medical settings. J Affect Disord. 2000 May;58(2):89–97. [PubMed]
  • Wang PS, Berglund P, Kessler RC. Recent care of common mental disorders in the United States : prevalence and conformance with evidence-based recommendations. J Gen Intern Med. 2000 May;15(5):284–292. [PMC free article] [PubMed]
  • Melfi CA, Croghan TW, Hanna MP, Robinson RL. Racial variation in antidepressant treatment in a Medicaid population. J Clin Psychiatry. 2000 Jan;61(1):16–21. [PubMed]
  • Sclar DA, Robison LM, Skaer TL, Dickson WM, Kozma CM, Reeder CE. Antidepressant prescribing patterns: a comparison of blacks and whites in a medicaid population. Clin Drug Investig. 1998;16(2):135–140. [PubMed]
  • Blazer DG, Hybels CF, Simonsick EM, Hanlon JT. Marked differences in antidepressant use by race in an elderly community sample: 1986-1996. Am J Psychiatry. 2000 Jul;157(7):1089–1094. [PubMed]
  • Lin KM. Biological differences in depression and anxiety across races and ethnic groups. J Clin Psychiatry. 2001;62 (Suppl 13):13–21. [PubMed]
  • Gaedigk Andrea, Bradford L DiAnne, Marcucci Kenda A, Leeder J Steven. Unique CYP2D6 activity distribution and genotype-phenotype discordance in black Americans. Clin Pharmacol Ther. 2002 Jul;72(1):76–89. [PubMed]
  • Bradford LD, Gaedigk A, Leeder JS. High frequency of CYP2D6 poor and "intermediate" metabolizers in black populations: a review and preliminary data. Psychopharmacol Bull. 1998;34(4):797–804. [PubMed]
  • Relling MV, Cherrie J, Schell MJ, Petros WP, Meyer WH, Evans WE. Lower prevalence of the debrisoquin oxidative poor metabolizer phenotype in American black versus white subjects. Clin Pharmacol Ther. 1991 Sep;50(3):308–313. [PubMed]
  • Ziegler VE, Biggs JT. Tricyclic plasma levels. Effect of age, race, sex, and smoking. JAMA. 1977 Nov 14;238(20):2167–2169. [PubMed]
  • Raskin A, Crook TH. Antidepressants in black and white inpatients. Differential response to a controlled trial of chlorpromazine and imipramine. Arch Gen Psychiatry. 1975 May;32(5):643–649. [PubMed]
  • Overall JE, Hollister LE, Kimbell I, Jr, Shelton J. Extrinsic factors influencing responses to psychotherapeutic drugs. Arch Gen Psychiatry. 1969 Jul;21(1):89–94. [PubMed]
  • Wagner GJ, Maguen S, Rabkin JG. Ethnic differences in response to fluoxetine in a controlled trial with depressed HIV-positive patients. Psychiatr Serv. 1998 Feb;49(2):239–240. [PubMed]
  • Rollman Bruce L, Hanusa Barbara H, Belnap Bea Herbeck, Gardner William, Cooper Lisa A, Schulberg Herbert C. Race, quality of depression care, and recovery from major depression in a primary care setting. Gen Hosp Psychiatry. 2002 Nov-Dec;24(6):381–390. [PubMed]
  • Fabrega H, Jr, Mulsant BM, Rifai AH, Sweet RA, Pasternak R, Ulrich R, Zubenko GS. Ethnicity and psychopathology in an aging hospital-based population. A comparison of African-American and Anglo-European patients. J Nerv Ment Dis. 1994 Mar;182(3):136–144. [PubMed]
  • Livingston RL, Zucker DK, Isenberg K, Wetzel RD. Tricyclic antidepressants and delirium. J Clin Psychiatry. 1983 May;44(5):173–176. [PubMed]
  • Nemeroff Charles B, Schatzberg Alan F, Goldstein David J, Detke Michael J, Mallinckrodt Craig, Lu Yili, Tran Pierre V. Duloxetine for the treatment of major depressive disorder. Psychopharmacol Bull. 2002 Autumn;36(4):106–132. [PubMed]
  • Goldstein David J, Mallinckrodt Craig, Lu Yili, Demitrack Mark A. Duloxetine in the treatment of major depressive disorder: a double-blind clinical trial. J Clin Psychiatry. 2002 Mar;63(3):225–231. [PubMed]
  • Goldstein David J, Lu Yili, Detke Michael J, Wiltse Curtis, Mallinckrodt Craig, Demitrack Mark A. Duloxetine in the treatment of depression: a double-blind placebo-controlled comparison with paroxetine. J Clin Psychopharmacol. 2004 Aug;24(4):389–399. [PubMed]
  • Detke Michael J, Lu Yili, Goldstein David J, Hayes John R, Demitrack Mark A. Duloxetine, 60 mg once daily, for major depressive disorder: a randomized double-blind placebo-controlled trial. J Clin Psychiatry. 2002 Apr;63(4):308–315. [PubMed]
  • Detke Michael J, Lu Yili, Goldstein David J, McNamara Robert K, Demitrack Mark A. Duloxetine 60 mg once daily dosing versus placebo in the acute treatment of major depression. J Psychiatr Res. 2002 Nov-Dec;36(6):383–390. [PubMed]
  • Brannan Stephen K, Mallinckrodt Craig H, Brown Eileen B, Wohlreich Madelaine M, Watkin John G, Schatzberg Alan F. Duloxetine 60 mg once-daily in the treatment of painful physical symptoms in patients with major depressive disorder. J Psychiatr Res. 2005 Jan;39(1):43–53. [PubMed]
  • HAMILTON M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960 Feb;23:56–62. [PMC free article] [PubMed]
  • DeLoach LJ, Higgins MS, Caplan AB, Stiff JL. The visual analog scale in the immediate postoperative period: intrasubject variability and correlation with a numeric scale. Anesth Analg. 1998 Jan;86(1):102–106. [PubMed]
  • Hunt SM, McKenna SP. The QLDS: a scale for the measurement of quality of life in depression. Health Policy. 1992 Oct;22(3):307–319. [PubMed]
  • Iwata Noboru, Turner R Jay, Lloyd Donald A. Race/ethnicity and depressive symptoms in community-dwelling young adults: a differential item functioning analysis. Psychiatry Res. 2002 Jul 31;110(3):281–289. [PubMed]
  • Brown C, Schulberg HC, Madonia MJ. Clinical presentations of major depression by African Americans and whites in primary medical care practice. J Affect Disord. 1996 Dec 16;41(3):181–191. [PubMed]
  • Riley Joseph L, 3rd, Wade James B, Myers Cynthia D, Sheffield David, Papas Rebecca K, Price Donald D. Racial/ethnic differences in the experience of chronic pain. Pain. 2002 Dec;100(3):291–298. [PubMed]
  • O'Sullivan MJ, Peterson PD, Cox GB, Kirkeby J. Ethnic populations: community mental health services ten years later. Am J Community Psychol. 1989 Feb;17(1):17–30. [PubMed]
  • Sue S, Fujino DC, Hu LT, Takeuchi DT, Zane NW. Community mental health services for ethnic minority groups: a test of the cultural responsiveness hypothesis. J Consult Clin Psychol. 1991 Aug;59(4):533–540. [PubMed]
  • Raskin Joel, Goldstein David J, Mallinckrodt Craig H, Ferguson Margaret B. Duloxetine in the long-term treatment of major depressive disorder. J Clin Psychiatry. 2003 Oct;64(10):1237–1244. [PubMed]

Articles from Journal of the National Medical Association are provided here courtesy of National Medical Association