Psychomotor symptoms and treatment outcomes of ziprasidone monotherapy in
patients with major depressive disorder: a 12-week, randomized, double-blind,
placebo-controlled, sequential parallel comparison trial.
Author(s): Jeon HJ(1), Fava M, Mischoulon D, Baer L, Clain A, Doorley J, DiPierro M, Cardoos
A, Papakostas GI.
Affiliation(s): Author information:
(1)aDepartment of Psychiatry, Depression Center, Samsung Medical Center,
Sungkyunkwan University School of Medicine bSamsung Advanced Institute for Health
Sciences & Technology (SAIHST), Seoul, Korea cDepression Clinical and Research
Program, Massachusetts General Hospital, Harvard Medical School, Boston,
Massachusetts, USA.
Publication date & source: 2014, Int Clin Psychopharmacol. , 29(6):332-8
The aim of this study was to evaluate efficacy of ziprasidone monotherapy for
major depressive disorder (MDD) with and without psychomotor symptoms. In
accordance with the sequential parallel comparison design, 106 MDD patients (age
44.0±10.7 years; female, 43.4%) were recruited and a post-hoc analysis was
carried out on 12-week double-blind treatment with either ziprasidone (40-160
mg/day) or placebo, divided into two phases of 6 weeks each to the assigned
treatment sequences, drug/drug, placebo/placebo, and placebo/drug. Psychomotor
symptoms were evaluated on the basis of the Mini-International Neuropsychiatric
Interview at baseline. Efficacy assessments, on the basis of the 17-item Hamilton
Depression Rating Scale (HDRS-17) and the Quick Inventory of Depressive
Symptomatology Scale, Self-Rated (QIDS-SR), were performed every week throughout
the trial. In phase I, ziprasidone monotherapy produced significant improvement
in patients with psychomotor symptoms compared with placebo on the basis of
HDRS-17 (F=5.95, P=0.017) and QIDS-SR (F=5.26, P=0.025) scores, whereas no
significant changes were found in HDRS-17 (F=2.32, P=0.15) and QIDS-SR (F=3.70,
P=0.074) scores in patients without psychomotor symptoms. In phase II,
ziprasidone monotherapy produced no significant differences compared with
placebo. In the pooled analysis, ziprasidone monotherapy showed significance
according to QIDS-SR (Z=2.00, P=0.046) and a trend toward statistical
significance according to the HDRS-17 (Z=1.66, P=0.10) in patients with
psychomotor symptoms. Ziprasidone monotherapy may produce significant improvement
compared with placebo in MDD patients with psychomotor symptoms.
|