期刊
BIOLOGICAL PSYCHIATRY
卷 79, 期 12, 页码 952-961出版社
ELSEVIER SCIENCE INC
DOI: 10.1016/j.biopsych.2015.08.026
关键词
Antipsychotic; Comorbid depression; Negative symptoms; Positive symptoms; Prosocial factor; Safety
资金
- Intra-Cellular Therapies, Inc. (ITI) [ITI-007-005]
- Biomarin
- EnVivo
- Genentech
- Lilly
- Novartis
- Psychogenics
- Sunovion
- ITI
- Eli Lilly and Company
- Genentech, Inc.
- Gerson Lehrman Group
- Janssen/Johnson Johnson
- Lundbeck, Inc.
- MedAvante
- Pfizer, Inc.
- ProPhase
- Otsuka Pharmaceuticals Co., Ltd.
- Roche
- Supernus
- Takeda Pharmaceuticals North America, Inc.
- Bristol-Myers Squibb Company
- Novo Nordisk
- AstraZeneca Pharmaceuticals LP
- Alkermes
- Bristol-Myers Squibb
- Eli Lilly
- Forrest
- Forum
- Janssen
- Johnson and Johnson
- Lundbeck
- Otsuka
- Reviva
- Pierre Fabre
- Astellas
- Kay Scholer LLC
- Pfizer
BACKGROUND: An urgent need exists for new treatments of schizophrenia that are effective against a broad range of symptoms and free of limiting safety issues. ITI-007 is a new molecular entity with a pharmacologic profile that combines dose-related monoamine modulation with phosphorylation of intracellular signaling proteins. METHODS: A phase II randomized, double-blind, placebo-controlled, and active-controlled trial was conducted at eight sites in the United States with randomization of 335 acutely psychotic adults with schizophrenia. ITI-007 (60 mg and 120 mg), placebo, and risperidone, included for assay sensitivity, were evaluated as monotherapy for 4 weeks. The primary outcome measure was the Positive and Negative Syndrome Scale total score, with secondary analyses conducted on symptom subscales. RESULTS: ITI-007 60 mg (p = .017, effect size 5.4) and risperidone (p = .013, effect size 5.4) demonstrated antipsychotic efficacy superiority over placebo on the primary end point. The results of secondary analyses reflected improvements in negative and depressive symptoms by ITI-007 60 mg. ITI-007 120 mg did not separate from placebo. However, both doses of ITI-007 were well tolerated in this patient population, as evidenced by low discontinuation and adverse event rates, and were associated with a benign metabolic profile as evidenced by significantly lower levels of prolactin, fasting glucose, total cholesterol, and triglycerides than risperidone. CONCLUSIONS: The mechanistically novel investigational drug ITI-007 was effective for the treatment of schizophrenia and comparable with placebo on safety measures in this trial. Secondary analyses indicated that ITI-007 improved negative and depression symptoms and might have expanded therapeutic efficacy in comparison with current antipsychotic drugs.
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