Efficacy of intravenous ketamine treatment in anxious versus nonanxious unipolar treatment-resistant depression
Naji C. Salloum, Maurizio Fava, Marlene P. Freeman, Martina Flynn, Bettina B. Hoeppner, Rebecca S. Hock, Cristina Cusin, Dan V. Iosifescu, Madhukar H. Trivedi, Gerard Sanacora, Sanjay J. Mathew, Charles DeBattista, Dawn F. Ionescu, George I. Papakostas
Depression and Anxiety December 30, 2018 DOI: 10.1002/da.22875 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial Placebo-controlled Double-blind Peer reviewed |
|---|---|
| Sample size | 99 |
| Population | Subjects with treatment-resistant depression |
| Interventions | Ketamine Midazolam |
| Dose | 0.1, 0.2, 0.5, 1.0 mg/kg ketamine; 0.045 mg/kg midazolam |
| Duration | 1 and 3 days postinfusion |
| Topics | Anxiety Depression Ketamine Esketamine |
| Keywords | Depression economics Psychotherapist Antidepressant |
| Citations | 49 |
| Key findings | No statistically significant interaction was found between treatment group (ketamine vs midazolam) and anxious/nonanxious status on depression scores at 1 or 3 days postinfusion. |
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.