CONTINUATION RILUZOLE IN PREVENTION OF RELAPSE FOLLOWING KETAMINE IN DEPRESSION

继续利鲁唑预防抑郁症服用氯胺酮后复发

• 批准号: 7953696
• 负责人: SANJAY J MATHEW
• 金额: $ 0.93万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-03-01 至 2009-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7953696
• 关键词: Acute; Address; Adult; Adverse effects; Affinity; Anesthesia procedures; Anesthetics; Animal Model; Anti-Anxiety Agents; Antidepressive Agents; Attenuated; Childhood; Clinical; Clinical Research; Computer Retrieval of Information on Scientific Projects Database; Dose; Double-Blind Method; Excitatory Amino Acid Antagonists; Exhibits; Funding; Grant; Institution; Intervention; Intravenous; Investigation; Ketamine; Maintenance; Major Depressive Disorder; Mood Disorders; Morbidity - disease rate; N-Methylaspartate; Neurocognitive; Outcome Measure; Pain management; Patients; Phase; Pilot Projects; Placebo Control; Placebos; Property; Protocols documentation; Randomized; Relapse; Research; Research Personnel; Resistance; Resources; Riluzole; Role; Sample Size; Source; Therapeutic; Time; Unipolar Depression; United States National Institutes of Health; depression; depressive symptoms; disorder later incidence prevention; efficacy testing; experience; lamotrigine; mortality; response; treatment strategy

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. 11/28/2006 Existing treatments for major depressive disorder (MDD) generally take several weeks to several months to exert their maximal benefit. Given the morbidity and mortality resulting from depressive symptoms, there is an urgent need to develop rapidly-acting treatments, as well as to identify optimal continuation treatment approaches. Ketamine, a high-affinity N-methyl-D-aspartate (NMDA) glutamate receptor antagonist, has been used as a standard anesthetic agent for many years in both pediatric and adult patients, with doses as high as 2 mg/kg IV. Beyond its well-established role in anesthesia and pain management, there is emerging evidence that ketamine has antidepressant and anxiolytic effects in animal models, and may have rapid antidepressant properties for patients with severe mood disorders. Indeed, a recent placebo-controlled investigation replicated an earlier pilot study (Berman et al 2000), and demonstrated robust antidepressant efficacy of a single dose of ketamine (0.5 mg/kg) in patients with treatment-resistant unipolar depression (Zarate et al 2006). A high proportion of these patients maintained the acute response to IV ketamine for several days or longer. To capitalize on the therapeutic promise of IV ketamine for MDD, several issues will be addressed in this new study. First, it is crucial to identify safe and effective continuation and maintenance treatment strategies following IV ketamine. Second, we need to develop pharmacological strategies that attenuate the acute neurocognitive side effects of IV ketamine, in order to enhance overall patient acceptability. Finally, clinical experience with IV ketamine in treatment-resistant MDD in larger sample sizes is necessary to identify moderators of response, to ultimately target the most appropriate candidates for this intervention. This research protocol will test the efficacy of riluzole (100 mg/day), in patients with treatment-resistant unipolar major depressive disorder (MDD) who exhibit an acute, sustained response to a single dose of intravenous (IV) racemic ketamine (0.5 mg/kg over 40 minutes). The efficacy of pretreatment with lamotrigine to attenuate IV ketamine's side effects will also be examined. We propose to randomize approximately 50 acute IV ketamine responders to riluzole (n=25) or placebo (n=25) in a 4-week, randomized, double-blind, continuation-phase study. The main outcome measure is time to relapse of depression.

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