From the Department of Psychiatry, Massachusetts General Hospital, Boston, MA.
Department of Psychiatry, Baylor College of Medicine/Michael E. Debakey VA Medical Center, Houston, TX.
J Clin Psychopharmacol. 2020 May/Jun;40(3):287-292. doi: 10.1097/JCP.0000000000001209.
PURPOSE/BACKGROUND: Major depressive disorder (MDD) and obesity commonly co-occur. We sought to assess the impact of body mass index (BMI) on the acute antidepressant effects of ketamine in patients with treatment-resistant depression.
METHODS/PROCEDURES: Post hoc analyses were conducted from a multisite, randomized, double-blind, placebo-controlled trial designed to assess the rapid-onset effects of intravenous ketamine. Patients (n = 99) were randomized to a single dose administration of ketamine 0.1 mg/kg (n = 18), ketamine 0.2 mg/kg (n = 20), ketamine 0.5 mg/kg (n = 22), ketamine 1.0 mg/kg (n = 20), or active placebo, midazolam 0.045 mg/kg (n = 19). Patients were stratified for BMI. For patients randomized to ketamine (n = 80), BMI was assessed as a continuous variable and also categorically (obese, overweight, not obese/overweight [reference]). The primary outcome measure was the change on the 6-item Hamilton Depression Rating Scale 24 hours after treatment. Outcomes at day 3 were also assessed.
FINDINGS/RESULTS: The 6-item Hamilton Depression Rating Scale change scores at 24 hours were inversely associated with BMI (-0.28 ± 0.12, P = 0.02). With BMI operationalized categorically, both obese (-4.15 ± 1.41, P = 0.004) and overweight (-1.99 ± 1.14, P = 0.08) categories were inversely related to the 6-item Hamilton Depression Rating Scale change score at 24 hours, statistically significant for the obese category, as compared with the reference group. Similar but weaker findings were observed at 72 hours after infusion.
IMPLICATIONS/CONCLUSIONS: Higher BMI and obesity were associated with a more robust acute antidepressant response to ketamine. This may have clinical relevance for a great number of patients who have both MDD and obesity.
NCT01920555.
目的/背景：重度抑郁症（MDD）和肥胖症通常同时发生。我们旨在评估体重指数（BMI）对接受难治性抑郁症治疗的患者使用氯胺酮的急性抗抑郁作用的影响。
方法/程序：这是一项多中心、随机、双盲、安慰剂对照试验的事后分析，旨在评估静脉注射氯胺酮的快速起效作用。将患者（n = 99）随机分为单次剂量氯胺酮 0.1mg/kg（n = 18）、氯胺酮 0.2mg/kg（n = 20）、氯胺酮 0.5mg/kg（n = 22）、氯胺酮 1.0mg/kg（n = 20）或活性安慰剂咪达唑仑 0.045mg/kg（n = 19）。根据 BMI 对患者进行分层。对于随机分配至氯胺酮组的患者（n = 80），BMI 被评估为连续变量和分类变量（肥胖、超重、不肥胖/超重[参考]）。主要结局测量是治疗后 24 小时的 6 项汉密尔顿抑郁量表评分变化。还评估了第 3 天的结果。
结果/发现：24 小时时的 6 项汉密尔顿抑郁量表评分变化与 BMI 呈负相关（-0.28 ± 0.12，P = 0.02）。当 BMI 以分类变量实施时，肥胖（-4.15 ± 1.41，P = 0.004）和超重（-1.99 ± 1.14，P = 0.08）类别与 24 小时时的 6 项汉密尔顿抑郁量表评分变化均呈负相关，肥胖类别与参考组相比具有统计学意义。输注后 72 小时观察到类似但较弱的发现。
结论/意义：更高的 BMI 和肥胖与氯胺酮急性抗抑郁反应更强烈相关。对于患有 MDD 和肥胖症的大量患者，这可能具有临床相关性。
NCT01920555。
