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Gepirone extended-release in the treatment of adult outpatients with major depressive disorder: a double-blind, randomized, placebo-controlled, parallel-group study.

Publication ,  Journal Article
Bielski, RJ; Cunningham, L; Horrigan, JP; Londborg, PD; Smith, WT; Weiss, K
Published in: J Clin Psychiatry
April 2008

OBJECTIVE: To evaluate the efficacy and tolerability of extended-release gepirone (gepirone-ER), a 5-HT(1A) agonist, versus placebo in the treatment of adult outpatients with major depressive disorder (MDD). METHOD: A double-blind, randomized, placebo-controlled, parallel-group, 8-week study was conducted from October 2003 to August 2004 in outpatients 18 to 64 years old with moderate-to-severe MDD, as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR), and a baseline Hamilton Rating Scale for Depression (HAM-D(17)) total score > or = 20. Patients were titrated from 20 to 80 mg/day of gepirone-ER or placebo (most patients received gepirone-ER 60 or 80 mg/day by week 3). The primary outcome measure was baseline-to-endpoint mean change in HAM-D(17) total score. Secondary outcome measures included the 28-item version of the HAM-D, HAM-D depressed mood (item 1), Bech Six-Item Scale, Montgomery-Asberg Depression Rating Scale, and Clinical Global Impressions scale. RESULTS: Significantly greater reductions in HAM-D(17) total scores occurred in gepirone-ER-treated patients compared with placebo-treated patients by week 4 (p = .004) and continued through weeks 6 (p = .006) and 8 (p = .032). Secondary outcomes also improved significantly at multiple timepoints, including at endpoint. The most frequently reported adverse events in the gepirone-ER versus placebo groups were dizziness (45% vs. 10%), nausea (36% vs. 13%), and headache (24% vs. 16%). Dizziness occurred most frequently during initial dosing and up-titration. CONCLUSIONS: Gepirone-ER significantly reduced depression symptoms and illness severity in MDD outpatients through the end of the study and was generally well tolerated, confirming previous findings.

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Published In

J Clin Psychiatry

DOI

EISSN

1555-2101

Publication Date

April 2008

Volume

69

Issue

4

Start / End Page

571 / 577

Location

United States

Related Subject Headings

  • Surveys and Questionnaires
  • Severity of Illness Index
  • Serotonin Receptor Agonists
  • Pyrimidines
  • Psychiatry
  • Middle Aged
  • Male
  • Humans
  • Female
  • Drug Administration Schedule
 

Citation

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Bielski, R. J., Cunningham, L., Horrigan, J. P., Londborg, P. D., Smith, W. T., & Weiss, K. (2008). Gepirone extended-release in the treatment of adult outpatients with major depressive disorder: a double-blind, randomized, placebo-controlled, parallel-group study. J Clin Psychiatry, 69(4), 571–577. https://doi.org/10.4088/jcp.v69n0408
Bielski, Robert J., Lynn Cunningham, Joseph P. Horrigan, Peter D. Londborg, Ward T. Smith, and Kenneth Weiss. “Gepirone extended-release in the treatment of adult outpatients with major depressive disorder: a double-blind, randomized, placebo-controlled, parallel-group study.J Clin Psychiatry 69, no. 4 (April 2008): 571–77. https://doi.org/10.4088/jcp.v69n0408.
Bielski RJ, Cunningham L, Horrigan JP, Londborg PD, Smith WT, Weiss K. Gepirone extended-release in the treatment of adult outpatients with major depressive disorder: a double-blind, randomized, placebo-controlled, parallel-group study. J Clin Psychiatry. 2008 Apr;69(4):571–7.
Bielski, Robert J., et al. “Gepirone extended-release in the treatment of adult outpatients with major depressive disorder: a double-blind, randomized, placebo-controlled, parallel-group study.J Clin Psychiatry, vol. 69, no. 4, Apr. 2008, pp. 571–77. Pubmed, doi:10.4088/jcp.v69n0408.
Bielski RJ, Cunningham L, Horrigan JP, Londborg PD, Smith WT, Weiss K. Gepirone extended-release in the treatment of adult outpatients with major depressive disorder: a double-blind, randomized, placebo-controlled, parallel-group study. J Clin Psychiatry. 2008 Apr;69(4):571–577.

Published In

J Clin Psychiatry

DOI

EISSN

1555-2101

Publication Date

April 2008

Volume

69

Issue

4

Start / End Page

571 / 577

Location

United States

Related Subject Headings

  • Surveys and Questionnaires
  • Severity of Illness Index
  • Serotonin Receptor Agonists
  • Pyrimidines
  • Psychiatry
  • Middle Aged
  • Male
  • Humans
  • Female
  • Drug Administration Schedule