Naji C Salloum1,2, Maurizio Fava1,2, Marlene P Freeman1,2, Martina Flynn1,2, Bettina Hoeppner1, Rebecca S Hock1, Cristina Cusin1, Dan V Iosifescu3, Madhukar H Trivedi4, Gerard Sanacora5, Sanjay J Mathew6, Charles Debattista7, Dawn F Ionescu1, George I Papakostas1,2. 1. Department of Psychiatry, Massachusetts General Hospital-Harvard Medical School, Boston, Massachusetts. 2. Clinical Trials Network and Institute, Massachusetts General Hospital, Boston, Massachusetts. 3. Department of Psychiatry, Nathan Kline Institute, New York University School of Medicine, New York, New York. 4. Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, Texas. 5. Department of Psychiatry, Yale School of Medicine, New Haven, Connecticut. 6. Michael E. Debakey VA Medical Center, Baylor College of Medicine, Houston, Texas. 7. Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California.
Abstract
OBJECTIVE: To examine the effect of high baseline anxiety on response to ketamine versus midazolam (active placebo) in treatment-resistant depression (TRD). METHODS: In a multisite, double-blind, placebo-controlled trial, 99 subjects with TRD were randomized to one of five arms: a single dose of intravenous ketamine 0.1, 0.2, 0.5, 1.0 mg/kg, or midazolam 0.045 mg/kg. The primary outcome measure was change in the six-item Hamilton Rating Scale for Depression (HAMD6). A linear mixed effects model was used to examine the effect of anxious depression baseline status (defined by a Hamilton Depression Rating Scale Anxiety-Somatization score ≥7) on response to ketamine versus midazolam at 1 and 3 days postinfusion. RESULTS: N = 45 subjects had anxious TRD, compared to N = 54 subjects without high anxiety at baseline. No statistically significant interaction effect was found between treatment group assignment (combined ketamine treatment groups versus midazolam) and anxious/nonanxious status on HAMD6 score at either days 1 or 3 postinfusion (Day 1: F(1, 84) = 0.02, P = 0.88; Day 3: F(1, 82) = 0.12, P = 0.73). CONCLUSION: In contrast with what is observed with traditional antidepressants, response to ketamine may be similar in both anxious and nonanxious TRD subjects. These pilot results suggest the potential utility of ketamine in the treatment of anxious TRD.
RCT Entities:
OBJECTIVE: To examine the effect of high baseline anxiety on response to ketamine versus midazolam (active placebo) in treatment-resistant depression (TRD). METHODS: In a multisite, double-blind, placebo-controlled trial, 99 subjects with TRD were randomized to one of five arms: a single dose of intravenous ketamine 0.1, 0.2, 0.5, 1.0 mg/kg, or midazolam 0.045 mg/kg. The primary outcome measure was change in the six-item Hamilton Rating Scale for Depression (HAMD6). A linear mixed effects model was used to examine the effect of anxious depression baseline status (defined by a Hamilton Depression Rating Scale Anxiety-Somatization score ≥7) on response to ketamine versus midazolam at 1 and 3 days postinfusion. RESULTS: N = 45 subjects had anxious TRD, compared to N = 54 subjects without high anxiety at baseline. No statistically significant interaction effect was found between treatment group assignment (combined ketamine treatment groups versus midazolam) and anxious/nonanxious status on HAMD6 score at either days 1 or 3 postinfusion (Day 1: F(1, 84) = 0.02, P = 0.88; Day 3: F(1, 82) = 0.12, P = 0.73). CONCLUSION: In contrast with what is observed with traditional antidepressants, response to ketamine may be similar in both anxious and nonanxious TRD subjects. These pilot results suggest the potential utility of ketamine in the treatment of anxious TRD.
Authors: Qiaosen Shen; Lisa Truong; Michael T Simonich; Changjiang Huang; Robyn L Tanguay; Qiaoxiang Dong Journal: Behav Brain Res Date: 2020-05-16 Impact factor: 3.332
Authors: Ella J Daly; Ibrahim Turkoz; Giacomo Salvadore; Maggie Fedgchin; Dawn F Ionescu; H Lynn Starr; Stephane Borentain; Madhukar H Trivedi; Michael E Thase; Jaskaran B Singh Journal: Depress Anxiety Date: 2021-07-22 Impact factor: 8.128