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A randomized controlled trial of duloxetine versus placebo in the treatment of nonmajor chronic depression.
J Clin Psychiatry 2012; 73(7):984-91JC

Abstract

OBJECTIVE

Numerous double-blind studies have assessed the efficacy of antidepressants in treating chronic depressive disorder, including dysthymic disorder, low-grade chronic depression. However, there are no double-blind, placebo-controlled studies of serotonin-norepinephrine reuptake inhibitors in chronic depressive disorder.

METHOD

Outpatients with chronic depressive disorder, but without concurrent major depressive disorder (MDD), were randomly assigned to prospective double-blind duloxetine (beginning at 30 mg/d, increased to a maximum dose of 120 mg/d) versus placebo for 10 weeks. Inclusion criteria were current DSM-IV-TR diagnosis of dysthymic disorder or depression not otherwise specified, age 18-75 years, and a Hamilton Depression Rating Scale (HDRS) score ≥ 12. Exclusion criteria included current major depression. The study was conducted between August 2006 and December 2011. HDRS, Cornell Dysthymia Rating Scale (CDRS), Clinical Global Impressions (CGI), Beck Depression Inventory (BDI), Global Assessment of Functioning (GAF), Social Adjustment Scale (SAS), and other assessments were administered at each visit. We hypothesized that duloxetine would be superior to placebo in (1) 24-item HDRS total score, (2) the percentage of subjects classified as responders and remitters, and (3) secondary measures (CDRS, BDI, CGI). Response was defined as > 50% decrease in 24-item HDRS and CGI-Improvement scale score of 1 or 2 ("very much improved" or "much improved"). Remission was defined as HDRS-17 item score ≤ 4 and 0 on item 1 of the HDRS (depressed mood).

RESULTS

65 subjects were enrolled, of whom 57 began medication. They ranged in age from 19 to 70 years (mean ± SD = 41.63 ± 11.22) and included 24 women and 33 men. Baseline 24-item HDRS score (mean ± SD) for both groups was 20.75 ± 4.92. After 10 weeks, duloxetine-treated subjects had significantly lower 24-item HDRS scores than placebo-treated subjects (time-by-drug group effect on analysis of variance: F1,55 = 9.43, P = .003). Responder and remitter analyses significantly favored duloxetine treatment. The response rate was 65.5% for duloxetine versus 25.0% for placebo (χ(2)(1) = 9.43, P = .003); and the remitter rate was 55.2% for duloxetine versus 14.3% for placebo (χ(2)(1) = 10.46, P = .002). After 10 weeks, duloxetine-treated subjects did not differ significantly better from placebo-treated subjects on the SAS (time-by-drug group effect on analysis of variance: F(1,46) = 0.35, P = .555) or on the GAF (time-by-drug group effect on analysis of variance: F(1,51) = .01, P = .922).

CONCLUSIONS

Results on the 24-item HDRS, CGI, and CDRS suggest that duloxetine is efficacious in acute treatment of chronic nonmajor depressive disorder. Response and remission rates also differed significantly, favoring duloxetine treatment, but BDI, GAF, and social functioning (Social Adjustment Scale) did not. Duloxetine appears to be effective in acute treatment of nonmajor chronic depression.

TRIAL REGISTRATION

ClinicalTrials.gov identifier: NCT00360724.

Authors+Show Affiliations

Depression Evaluation Service, Department of Clinical Therapeutics, New York State Psychiatric Institute, NY 10032, USA. hellers@nyspi.columbia.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22901348

Citation

Hellerstein, David J., et al. "A Randomized Controlled Trial of Duloxetine Versus Placebo in the Treatment of Nonmajor Chronic Depression." The Journal of Clinical Psychiatry, vol. 73, no. 7, 2012, pp. 984-91.
Hellerstein DJ, Stewart JW, McGrath PJ, et al. A randomized controlled trial of duloxetine versus placebo in the treatment of nonmajor chronic depression. J Clin Psychiatry. 2012;73(7):984-91.
Hellerstein, D. J., Stewart, J. W., McGrath, P. J., Deliyannides, D. A., Batchelder, S. T., Black, S. R., ... Chen, Y. (2012). A randomized controlled trial of duloxetine versus placebo in the treatment of nonmajor chronic depression. The Journal of Clinical Psychiatry, 73(7), pp. 984-91. doi:10.4088/JCP.11m07230.
Hellerstein DJ, et al. A Randomized Controlled Trial of Duloxetine Versus Placebo in the Treatment of Nonmajor Chronic Depression. J Clin Psychiatry. 2012;73(7):984-91. PubMed PMID: 22901348.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized controlled trial of duloxetine versus placebo in the treatment of nonmajor chronic depression. AU - Hellerstein,David J, AU - Stewart,Jonathan W, AU - McGrath,Patrick J, AU - Deliyannides,Deborah A, AU - Batchelder,Sarai T, AU - Black,Sarah R, AU - Withers,Amy, AU - O'Shea,Donna, AU - Chen,Ying, PY - 2011/06/24/received PY - 2012/01/03/accepted PY - 2012/8/21/entrez PY - 2012/8/21/pubmed PY - 2012/10/24/medline SP - 984 EP - 91 JF - The Journal of clinical psychiatry JO - J Clin Psychiatry VL - 73 IS - 7 N2 - OBJECTIVE: Numerous double-blind studies have assessed the efficacy of antidepressants in treating chronic depressive disorder, including dysthymic disorder, low-grade chronic depression. However, there are no double-blind, placebo-controlled studies of serotonin-norepinephrine reuptake inhibitors in chronic depressive disorder. METHOD: Outpatients with chronic depressive disorder, but without concurrent major depressive disorder (MDD), were randomly assigned to prospective double-blind duloxetine (beginning at 30 mg/d, increased to a maximum dose of 120 mg/d) versus placebo for 10 weeks. Inclusion criteria were current DSM-IV-TR diagnosis of dysthymic disorder or depression not otherwise specified, age 18-75 years, and a Hamilton Depression Rating Scale (HDRS) score ≥ 12. Exclusion criteria included current major depression. The study was conducted between August 2006 and December 2011. HDRS, Cornell Dysthymia Rating Scale (CDRS), Clinical Global Impressions (CGI), Beck Depression Inventory (BDI), Global Assessment of Functioning (GAF), Social Adjustment Scale (SAS), and other assessments were administered at each visit. We hypothesized that duloxetine would be superior to placebo in (1) 24-item HDRS total score, (2) the percentage of subjects classified as responders and remitters, and (3) secondary measures (CDRS, BDI, CGI). Response was defined as > 50% decrease in 24-item HDRS and CGI-Improvement scale score of 1 or 2 ("very much improved" or "much improved"). Remission was defined as HDRS-17 item score ≤ 4 and 0 on item 1 of the HDRS (depressed mood). RESULTS: 65 subjects were enrolled, of whom 57 began medication. They ranged in age from 19 to 70 years (mean ± SD = 41.63 ± 11.22) and included 24 women and 33 men. Baseline 24-item HDRS score (mean ± SD) for both groups was 20.75 ± 4.92. After 10 weeks, duloxetine-treated subjects had significantly lower 24-item HDRS scores than placebo-treated subjects (time-by-drug group effect on analysis of variance: F1,55 = 9.43, P = .003). Responder and remitter analyses significantly favored duloxetine treatment. The response rate was 65.5% for duloxetine versus 25.0% for placebo (χ(2)(1) = 9.43, P = .003); and the remitter rate was 55.2% for duloxetine versus 14.3% for placebo (χ(2)(1) = 10.46, P = .002). After 10 weeks, duloxetine-treated subjects did not differ significantly better from placebo-treated subjects on the SAS (time-by-drug group effect on analysis of variance: F(1,46) = 0.35, P = .555) or on the GAF (time-by-drug group effect on analysis of variance: F(1,51) = .01, P = .922). CONCLUSIONS: Results on the 24-item HDRS, CGI, and CDRS suggest that duloxetine is efficacious in acute treatment of chronic nonmajor depressive disorder. Response and remission rates also differed significantly, favoring duloxetine treatment, but BDI, GAF, and social functioning (Social Adjustment Scale) did not. Duloxetine appears to be effective in acute treatment of nonmajor chronic depression. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00360724. SN - 1555-2101 UR - https://www.unboundmedicine.com/medline/citation/22901348/A_randomized_controlled_trial_of_duloxetine_versus_placebo_in_the_treatment_of_nonmajor_chronic_depression_ L2 - http://www.psychiatrist.com/jcp/article/pages/2012/v73n07/v73n0715.aspx DB - PRIME DP - Unbound Medicine ER -