Abstract | OBJECTIVE: METHODS: Patient-level data were pooled from 4 similarly designed, double-blind, placebo-controlled, 6-week registration studies of lurasidone (40-160 mg/d) in adult patients with an acute exacerbation of schizophrenia. Changes in depressive symptoms, measured by the Montgomery-Åsberg Depression Rating Scale (MADRS), were analyzed for the overall sample and for subgroups of patients stratified by baseline MADRS scores. RESULTS: MADRS assessments at baseline and endpoint (day 42 or last observation carried forward [LOCF]) were available for 1330 patients. Patients receiving lurasidone experienced significantly greater decreases in MADRS score (-2.8, least-squares [LS] mean change, LOCF) compared with patients receiving placebo (-1.4, P < .001, effect size 0.24). Analysis of change in MADRS score (LOCF) by baseline symptom severity (MADRS score of ≥12, ≥14, ≥16, ≥18) showed significantly greater improvement for lurasidone-treated patients across all severity groups; effect sizes ranged from 0.25 to 0.34. Among patients with a baseline MADRS score of ≥12, depressive symptom remission (defined as MADRS score <10 at LOCF endpoint) was attained by 45.0% of lurasidone-treated patients and 36.3% of patients receiving placebo (P < .05). CONCLUSIONS: In a pooled analysis of short-term, placebo-controlled studies, lurasidone significantly improved depressive symptoms in patients with schizophrenia.
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Authors | Henry A Nasrallah, Josephine B Cucchiaro, Yongcai Mao, Andrei A Pikalov, Antony D Loebel |
Journal | CNS spectrums
(CNS Spectr)
Vol. 20
Issue 2
Pg. 140-7
(Apr 2015)
ISSN: 1092-8529 [Print] United States |
PMID | 24955752
(Publication Type: Clinical Trial, Phase I, Clinical Trial, Phase II, Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antipsychotic Agents
- Isoindoles
- Thiazoles
- Lurasidone Hydrochloride
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Topics |
- Adolescent
- Adult
- Aged
- Antipsychotic Agents
(therapeutic use)
- Depressive Disorder
(drug therapy, etiology)
- Double-Blind Method
- Female
- Humans
- Isoindoles
(therapeutic use)
- Lurasidone Hydrochloride
- Male
- Middle Aged
- Psychiatric Status Rating Scales
- Schizophrenia
(complications)
- Thiazoles
(therapeutic use)
- Young Adult
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