title: Efficacy of ziprasidone monotherapy in patients with anxious depression: a 12-week, randomized, double-blind, placebo-controlled, sequential-parallel comparison trial.
abstract: 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.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier: NCT00555997.
authors: Department of Psychiatry, Depression Center, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
authors: Jung-Yoon
authors: JY
authors: Heo
authors: Department of Psychiatry, Depression Center, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea; Depression Clinical and Research Program, Massachusetts General Hospital, Harvard Medical School, Boston, USA; Department of Clinical Research Design and Evaluation and Department of Medical Device Management and Research, Samsung Advanced Institute for Health Sciences & Technology (SAIHST), Sungkyunkwan University, Seoul, Korea. Electronic address: jeonhj@skku.edu.
authors: Hong Jin
authors: HJ
authors: Jeon
authors: Depression Clinical and Research Program, Massachusetts General Hospital, Harvard Medical School, Boston, USA.
authors: Maurizio
authors: M
authors: Fava
authors: Depression Clinical and Research Program, Massachusetts General Hospital, Harvard Medical School, Boston, USA.
authors: David
authors: D
authors: Mischoulon
authors: Depression Clinical and Research Program, Massachusetts General Hospital, Harvard Medical School, Boston, USA.
authors: Lee
authors: L
authors: Baer
authors: Depression Clinical and Research Program, Massachusetts General Hospital, Harvard Medical School, Boston, USA.
authors: Alisabet
authors: A
authors: Clain
authors: Depression Clinical and Research Program, Massachusetts General Hospital, Harvard Medical School, Boston, USA.
authors: James
authors: J
authors: Doorley
authors: Depression Clinical and Research Program, Massachusetts General Hospital, Harvard Medical School, Boston, USA.
authors: Angela
authors: A
authors: Pisoni
authors: Depression Clinical and Research Program, Massachusetts General Hospital, Harvard Medical School, Boston, USA.
authors: George I
authors: GI
authors: Papakostas
mesh_terms: D000328:Adult; D000928:Antidepressive Agents / Q000627:therapeutic use*; D001008:Anxiety Disorders / Q000150:complications; D003863:Depression / Q000188:drug therapy* / Q000209:etiology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010879:Piperazines / Q000627:therapeutic use*; D011569:Psychiatric Status Rating Scales; D013844:Thiazoles / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000928:Antidepressive Agents; D010879:Piperazines; D013844:Thiazoles; C092292:ziprasidone
keywords: Anxious depression; Efficacy; Major depressive disorder; Monotherapy; Ziprasidone