Cited by 6Treatment of Major DepressionAnxiety, Depression, Psychometrics, Treatment, Cognitive ProcessesPsychological Treatments and Disorders

Efficacy of ziprasidone monotherapy in patients with anxious depression: a 12-week, randomized, double-blind, placebo-controlled, sequential-parallel comparison trial

Heo, Jung-Yoon, Jeon, Hong Jin, Fava, Maurizio, Mischoulon, David, Baer, Lee, Clain, Alisabet, Doorley, James, Pisoni, Angela +1 more·2015·Journal of Psychiatric Research

Abstract

Unlabelled Anxious depression, defined as major depressive disorder (MDD) accompanied by high levels of anxiety, seems to be difficult to treat with traditional antidepressant monotherapy. The purpose of this study was to assess the efficacy of ziprasidone monotherapy in patients with anxious depression versus non-anxious depression. One hundred and twenty outpatients were enrolled in a 12-week study that was divided into two 6-week periods according to the sequential parallel comparison design. Patients were randomized in a 2:3:3 multi-ratio to receive ziprasidone for 12 weeks, placebo for 6 weeks, followed by ziprasidone for 6 weeks, or placebo for 12 weeks. Efficacy was measured according to the 17-item Hamilton Depression Rating Scale (HRDS-17), Quick Inventory of Depressive Symptomatology Self-Rated (QIDS-SR). Anxious depression was defined as a score of ≥7 on the HDRS-17 anxiety/somatization subscale. In phase I and II, ziprasidone monotherapy led to no significant changes compared with placebo on the HDRS-17 and QIDS-SR scores in patients with both anxious and non-anxious depression. In the pooled analysis, ziprasidone monotherapy also produced no significance on the HDRS-17 (Z = 0.25, P = 0.80) and QIDS-SR (Z = 0.43, P = 0.67) in patients with anxious depression. In conclusion, treatment with ziprasidone monotherapy may produce no significant improvement compared with placebo in patients with in anxious depression.Trial registration ClinicalTrials.gov identifier: NCT00555997.

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Crossref · 10.1016/j.jpsychires.2015.01.007

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Authors
Heo, J.-Y., Jeon, H. J., Fava, M., Mischoulon, D., Baer, L., Clain, A., Doorley, J., Pisoni, A., & Papakostas, G. I.
Affiliations
  • Samsung Medical Center (KR)
  • Harvard University (US)
Corresponding author
Jeon, Hong Jin
Venue
Journal of Psychiatric Research
Publisher
Elsevier BV
Published
2015-03
Volume
62
Pages
56-61
ISSN
0022-3956 (ISSN-L)
OpenAlex
W2162955846
Cited by
6
References
36
Citations by year
2024: 1 · 2020: 1 · 2017: 2 · 2016: 1 · 2015: 1
FWCI
0.96
Type
journal article
Language
en
Open access
closed
Locations
  • Journal of Psychiatric Research (publishedVersion)
  • PubMed (publishedVersion)
Funders
  • Ministry of Education, Science and Technology (2011-0013064)
  • Samsung Medical Center Clinical Research Development Program (SMO1131461)
Topics
  • Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
  • Social Sciences › Psychology › Experimental and Cognitive Psychology › Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes
  • Social Sciences › Psychology › Clinical Psychology › Psychological Treatments and Disorders
Keywords
ziprasidone, anxious depression, major depressive disorder, antidepressant monotherapy, atypical antipsychotics, depression treatment efficacy, placebo comparison
MeSH terms
Adult, Antidepressive Agents, Anxiety Disorders, Depression, Double-Blind Method, Female, Humans, Male, Middle Aged, Piperazines, Psychiatric Status Rating Scales, Thiazoles, Treatment Outcome

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