期刊
AMERICAN JOURNAL OF PSYCHIATRY
卷 173, 期 8, 页码 816-826出版社
AMER PSYCHIATRIC PUBLISHING, INC
DOI: 10.1176/appi.ajp.2016.16010037
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资金
- Janssen Research and Development
- Johnson Johnson
- Avanir
- AstraZeneca
- Bristol-Myers Squibb
- Squibb
- Eli Lilly
- Janssen
- Hoffman-La Roche
- Merck
- Naurex
- Servier
- Sanofi-Aventis
- Alkermes
- Assurex
- Elan
- Euthymics Bioscience
- Forest
- Novartis
- Otsuka
- Pamlab
- Pfizer
- Repligen
- St. Jude Medical
- Takeda
- NIMH
- Mitsubishi Tanabe Pharma
- Roche
- Shire
- Acadia
- AXSOME Therapeutics
- Biogen
- Cerecor
- Dinippon Sumitomo Pharma
- EnVivo
- Forest Pharmaceuticals
- FORUM Pharmaceuticals
- GenOmind
- GlaxoSmithKline
- Indivior
- Intracellular
- Johnson & Johnson Pharmaceutical Research and Development
- Lundbeck
- Methylation Sciences
- MSI Methylation Sciences
- National Center for Complementary and Alternative Medicine
- National Coordinating Center for Integrative Medicine
- NIDA
- Nestle Health Sciences
- Neuralstem
- NeuroRx
- Novartis AG
- Nutrition 21
- Osmotica
- Otsuka Pharmaceuticals
- PharmoRx Therapeutics
- Photothera
- PPD
- Puretech Ventures
- PsychoGenics
- RCT Logic
- Reckitt Benckiser
- Ridge Diagnostics
- Roche Pharmaceuticals
- Servier Laboratories
- Stanley Medical Research Institute
- Sunovion
- Taisho
- Tal Medical
- VistaGen
Objective: Ketamine, an N-methyl-D-aspartate glutamate receptor antagonist, has demonstrated a rapid-onset antidepressant effect in patients with treatment-resistant depression. This study evaluated the efficacy of twice-and thrice-weekly intravenous administration of ketamine in sustaining initial antidepressant effects in patients with treatment-resistant depression. Method: In a multicenter, double-blind study, adults (ages 18-64 years) with treatment-resistant depression were randomized to receive either intravenous ketamine (0.5 mg/kg of body weight) or intravenous placebo, administered over 40 minutes, either two or three times weekly, for up to 4 weeks. Patients who discontinued double-blind treatment after at least 2 weeks for lack of efficacy could enter an optional 2-week open-label phase to receive ketamine with the same frequency as in the double-blind phase. The primary outcome measure was change from baseline to day 15 in total score on the Montgomery-angstrom sberg Depression Rating Scale (MADRS). Results: In total, 67 (45 women) of 68 randomized patients received treatment. In the twice-weekly dosing groups, the mean change in MADRS score at day 15 was -18.4 (SD=12.0) for ketamine and -5.7 (SD=10.2) for placebo; in the thrice-weekly groups, it was -17.7 (SD=7.3) for ketamine and -3.1 (SD=5.7) for placebo. Similar observations were noted for ketamine during the open-label phase (twice-weekly, -12.2 [SD=12.8] on day 4; thrice-weekly, -14.0 [SD=12.5] on day 5). Both regimens were generally well tolerated. Headache, anxiety, dissociation, nausea, and dizziness were the most common (>= 20%) treatment-emergent adverse events. Dissociative symptoms occurred transiently and attenuated with repeated dosing. Conclusions: Twice-weekly and thrice-weekly administration of ketamine at 0.5 mg/kg similarly maintained antidepressant efficacy over 15 days.
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