Efficacy of ziprasidone monotherapy in patients with anxious depression: a 12-week, randomized, double-blind, placebo-controlled, sequential-parallel comparison trial
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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One large study found efficacy of quetiapine adjunct therapy in both patients with anxious and nonanxious depression.
“One large study found efficacy of quetiapine adjunct therapy in both patients with anxious and nonanxious depression [53].”
From Patients with anxious depression: overview of prevalence, pathophysiology and impact on course and treatment outcome (2018) · cites this paper as [53]
Findings on quetiapine adjunct therapy were inconsistent across definitions of anxious depression and different quetiapine dosages.
“However, the findings were inconsistent across definitions of anxious depression and different quetiapine dosages [53].”
From Patients with anxious depression: overview of prevalence, pathophysiology and impact on course and treatment outcome (2018) · cites this paper as [53]
Cites
Diagnostic and Statistical Manual of Mental Disorders
Williams, J. B. W., & First, M. B. (2013) · Oxford University Press eBooks · doi:10.1093/acrefore/9780199975839.013.104 · Cited by 109,841 · see citing works
Hamilton, M. (1960) · Journal of Neurology, Neurosurgery & Psychiatry · doi:10.1136/jnnp.23.1.56 · Cited by 32,817 · see citing works
(1998) · The Journal of Clinical Psychiatry · Cited by 19,139 · see citing works
TRIVEDI, M. H., RUSH, A. J., IBRAHIM, H. M., CARMODY, T. J., BIGGS, M. M., SUPPES, T., CRISMON, M. L., SHORES-WILSON, K., TOPRAC, M. G., DENNEHY, E. B., et al. (2004) · Psychological Medicine · doi:10.1017/s0033291703001107 · Cited by 968 · see citing works
Fava, M., Rush, A. J., Alpert, J. E., Balasubramani, G. K., Wisniewski, S. R., Carmin, C. N., Biggs, M. M., Zisook, S., Leuchter, A., Howland, R., et al. (2008) · American Journal of Psychiatry · doi:10.1176/appi.ajp.2007.06111868 · Cited by 927 · see citing works
Self-citationBinding of antipsychotic drugs to human brain receptors
Richelson, E., & Souder, T. (2000) · Life Sciences · doi:10.1016/s0024-3205(00)00911-5 · Cited by 608 · see citing works
Postpartum mood disorders: diagnosis and treatment guidelines.
Nonacs, R. M., & Cohen, L. S. (1998) · PubMed · Cited by 588 · see citing works
Fava, M., Evins, A. E., Dorer, D. J., & Schoenfeld, D. A. (2003) · Psychotherapy and Psychosomatics · doi:10.1159/000069738 · Cited by 452 · see citing works
Self-citationFAVA, M., ALPERT, J. E., CARMIN, C. N., WISNIEWSKI, S. R., TRIVEDI, M. H., BIGGS, M. M., SHORES-WILSON, K., MORGAN, D., SCHWARTZ, T., BALASUBRAMANI, G. K., et al. (2004) · Psychological Medicine · doi:10.1017/s0033291704002612 · Cited by 406 · see citing works
Self-citationDaniel, D. G. (1999) · Neuropsychopharmacology · doi:10.1016/s0893-133x(98)00090-6 · Cited by 376 · see citing works
Agonist and antagonist actions of antipsychotic agents at 5-HT1A receptors: a []GTPγS binding study
Newman‐Tancredi, A., Gavaudan, S., Conte, C., Chaput, C., Touzard, M., Verrièle, L., Audinot, V., & Millan, M. J. (1998) · European Journal of Pharmacology · doi:10.1016/s0014-2999(98)00483-x · Cited by 225 · see citing works
Stahl, S. M., Zhang, L., Damatarca, C., & Grady, M. M. (2003) · PubMed · Cited by 202 · see citing works
Rollema, H., Lu, Y., Schmidt, A. W., Sprouse, J. S., & Zorn, S. H. (2000) · Biological Psychiatry · doi:10.1016/s0006-3223(00)00850-7 · Cited by 195 · see citing works
Anxiety syndromes and their relationship to depressive illness.
FAWCETT, J. A., & Kravitz, H. M. (1983) · PubMed · Cited by 174 · see citing works
Clinical Effects of the 5-HT1A Partial Agonists in Depression
Robinson, D. S., Rickels, K., Feighner, J. P., Fabre, L. F., Gammans, R. E., Shrotriya, R. C., Alms, D. R., ANDARY, J. J., & MESSINA, M. E. (1990) · Journal of Clinical Psychopharmacology · doi:10.1097/00004714-199006001-00013 · Cited by 172 · see citing works
Stahl, S. M., & Shayegan, D. K. (2003) · PubMed · Cited by 146 · see citing works
NEUROBIOLOGY OF ANXIOUS DEPRESSION: A REVIEW
Ionescu, D. F., Niciu, M. J., Mathews, D. C., Richards, E. M., & Zarate, C. A. (2013) · Depression and Anxiety · doi:10.1002/da.22095 · Cited by 140 · see citing works
Dimensions in major depressive disorder and their relevance for treatment outcome
Vrieze, E., Demyttenaere, K., Bruffaerts, R., Hermans, D., Pizzagalli, D. A., Sienaert, P., Hompes, T., de Boer, P., Schmidt, M., & Claes, S. (2014) · Journal of Affective Disorders · doi:10.1016/j.jad.2013.10.020 · Cited by 138 · see citing works
Tollefson, G. D., Holman, S., Sayler, M. E., & Potvin, J. H. (1994) · PubMed · Cited by 135 · see citing works
Anxious and nonanxious depression
Joffe, R. T., Bagby, R. M., & LEVITT, A. J. (1993) · American Journal of Psychiatry · doi:10.1176/ajp.150.8.1257 · Cited by 122 · see citing works
Pharmacological profile of neuroleptics at human monoamine transporters
Tatsumi, M., Jansen, K. R., Blakely, R., et al. (1999) · European Journal of Pharmacology · doi:10.1016/s0014-2999(99)00005-9 · Cited by 110 · see citing works
Distinctive clinical characteristics and suicidal tendencies of patients with anxious depression
Seo, H.-J., Jung, Y.-E., Kim, T.-S., Kim, J.-B., Lee, M.-S., Kim, J.-M., Lim, H.-W., & Jun, T.-Y. (2011) · Journal of Nervous & Mental Disease · doi:10.1097/nmd.0b013e3182043b60 · Cited by 94 · see citing works
From Clinical Research to Clinical Practice: A 4-Year Review of Ziprasidone
Masand, P. S., Nemeroff, C. B., Newcomer, J. W., Lieberman, J. A., Schatzberg, A. F., Weiden, P. J., Kilts, C. D., Harvey, P. D., & Daniel, D. G. (2005) · CNS Spectrums · doi:10.1017/s1092852900019842 · Cited by 90 · see citing works
Efficacy and Tolerability of Adjunctive Ziprasidone in Treatment-Resistant Depression
Dünner, D. L., Amsterdam, J. D., Shelton, R. C., et al. (2007) · The Journal of Clinical Psychiatry · doi:10.4088/jcp.v68n0714 · Cited by 80 · see citing works
An examination of the efficiency of the sequential parallel design in psychiatric clinical trials
Tamura, R., & Huang, X. (2007) · Clinical Trials · doi:10.1177/1740774507081217 · Cited by 73 · see citing works
Thase, M. E., Demyttenaere, K., Earley, W. R., Gustafsson, U., Udd, M., & Eriksson, H. (2012) · Depression and Anxiety · doi:10.1002/da.21970 · Cited by 45 · see citing works
D, M. F. M., Schaefer, K., Huang, H., Wilson, A., Iosifescu, D. V., Mischoulon, D., & Wessel, T. C. (2010) · The Journal of Clinical Psychiatry · doi:10.4088/jcp.09m05131gry · Cited by 43 · see citing works
Self-citationPapakostas, G. I., & Larsen, K. G. (2010) · European Archives of Psychiatry and Clinical Neuroscience · doi:10.1007/s00406-010-0149-3 · Cited by 41 · see citing works
Self-citationPapakostas, G. I., Fan, H., & Tedeschini, E. (2011) · European Neuropsychopharmacology · doi:10.1016/j.euroneuro.2011.09.009 · Cited by 41 · see citing works
Self-citationNorepinephrine transporter occupancy in the human brain after oral administration of quetiapine XR
Nyberg, S., Jučaitė, A., Takano, A., Kågedal, M., Cselényi, Z., Halldin, C., & Farde, L. (2013) · The International Journal of Neuropsychopharmacology · doi:10.1017/s1461145713000680 · Cited by 38 · see citing works
Neurobiological bases of quetiapine antidepresant effect in the bipolar disorder.
Prieto, E., Micó, J. A., Meana, J. J., & Majadas, S. (2010) · PubMed · Cited by 34 · see citing works
Papakostas, G. I., Vitolo, O. V., IsHak, W. W., Rapaport, M. H., Zajecka, J., Kinrys, G., Mischoulon, D., Lipkin, S., Hails, K. A., Abrams, J., et al. (2012) · The Journal of Clinical Psychiatry · doi:10.4088/jcp.12m07670 · Cited by 32 · see citing works
Self-citationFava, M., Martinez, J. M., Greist, J., Marangell, L. B., Brown, E., Chen, L., & Wohlreich, M. M. (2007) · Annals of Clinical Psychiatry · doi:10.1080/10401230701465178 · Cited by 25 · see citing works
Bandelow, B., Bauer, M., Vieta, E., El-Khalili, N., Gustafsson, U., Earley, W. R., & Eriksson, H. (2014) · The World Journal of Biological Psychiatry · doi:10.3109/15622975.2013.842654 · Cited by 18 · see citing works
Jeon, H. J., D, M. F. M., Mischoulon, D., Baer, L., Clain, A. J., Doorley, J. D., DiPierro, M., Cardoos, A., & Papakostas, G. I. (2014) · International Clinical Psychopharmacology · doi:10.1097/yic.0000000000000039 · Cited by 6 · see citing works
Self-citationExperience of the use of velaxin (venlafaxine) in anxious depression
Алексеевна, И. Н. (2009) · Neuroscience and Behavioral Physiology · doi:10.1007/s11055-009-9127-5 · Cited by 2 · see citing works
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Gaspersz, R., Nawijn, L., Lamers, F., & Penninx, B. W. J. H. (2018) · Current Opinion in Psychiatry · doi:10.1097/yco.0000000000000376 · Cited by 139 · see citing works
- 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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