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A randomized controlled trial of intranasal ketamine in major depressive disorder.

ABSTRACT: The N-methyl-D-aspartate glutamate receptor antagonist ketamine, delivered via an intravenous route, has shown rapid antidepressant effects in patients with treatment-resistant depression. The current study was designed to test the safety, tolerability, and efficacy of intranasal ketamine in patients with depression who had failed at least one prior antidepressant trial.In a randomized, double-blind, crossover study, 20 patients with major depression were randomly assigned, and 18 completed 2 treatment days with intranasal ketamine hydrochloride (50 mg) or saline solution. The primary efficacy outcome measure was change in depression severity 24 hours after ketamine or placebo, measured using the Montgomery-Åsberg Depression Rating Scale. Secondary outcomes included persistence of benefit, changes in self-reports of depression, changes in anxiety, and proportion of responders. Potential psychotomimetic, dissociative, hemodynamic, and general adverse effects associated with ketamine were also measured.Patients showed significant improvement in depressive symptoms at 24 hours after ketamine compared to placebo (t = 4.39, p < .001; estimated mean Montgomery-Åsberg Depression Rating Scale score difference of 7.6 ± 3.7; 95% confidence interval, 3.9-11.3). Response criteria were met by 8 of 18 patients (44%) 24 hours after ketamine administration compared with 1 of 18 (6%) after placebo (p = .033). Intranasal ketamine was well tolerated with minimal psychotomimetic or dissociative effects and was not associated with clinically significant changes in hemodynamic parameters.This study provides the first controlled evidence for the rapid antidepressant effects of intranasal ketamine. Treatment was associated with minimal adverse effects. If replicated, these findings may lead to novel approaches to the pharmacologic treatment of patients with major depression.

SUBMITTER: Lapidus KA

PROVIDER: S-EPMC4185009 | biostudies-literature | 2014 Dec

REPOSITORIES: biostudies-literature

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A randomized controlled trial of intranasal ketamine in major depressive disorder.

Lapidus Kyle A B KA Levitch Cara F CF Perez Andrew M AM Brallier Jess W JW Parides Michael K MK Soleimani Laili L Feder Adriana A Iosifescu Dan V DV Charney Dennis S DS Murrough James W JW

Biological psychiatry 20140403 12

<h4>Background</h4>The N-methyl-D-aspartate glutamate receptor antagonist ketamine, delivered via an intravenous route, has shown rapid antidepressant effects in patients with treatment-resistant depression. The current study was designed to test the safety, tolerability, and efficacy of intranasal ketamine in patients with depression who had failed at least one prior antidepressant trial.<h4>Methods</h4>In a randomized, double-blind, crossover study, 20 patients with major depression were rando ...[more]

PMID: 24821196

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Project description:Study objectivesTo evaluate the efficacy and safety of electroacupuncture as an additional treatment for residual insomnia associated with major depressive disorder (MDD).DesignRandomized, placebo-controlled.SettingA psychiatric outpatient clinic.Participants78 Chinese patients with DSM-IV-diagnosed MDD, insomnia complaint, a Hamilton Rating Scale for Depression (HDRS(17)) score ≤ 18, and fixed antidepressant dosage.InterventionElectroacupuncture, minimal acupuncture (superficial needling at non-acupuncture points), or noninvasive placebo acupuncture 3 sessions weekly for 3 weeks.Measurements and resultsInsomnia Severity Index (ISI), Pittsburgh Sleep Quality Index (PSQI), HDRS(17), 1 week sleep diaries, and 3 day actigraphy were administered at baseline, 1 week post-treatment, and 4 week post-treatment. There was significant group by time interaction in ISI, PSQI, and sleep diary-derived sleep efficiency (mixed-effects models, P = 0.04, P = 0.03, and P = 0.01, respectively). Post hoc pairwise comparisons revealed that electroacupuncture and minimal acupuncture were more efficacious than placebo acupuncture in ISI and PSQI at 1 week and 4 week post-treatment. Minimal acupuncture resulted in greater improvement in sleep diary-derived sleep efficiency than placebo acupuncture at 1 week post-treatment. There was no significant between-group difference in actigraphy measures, depressive symptoms, daily functioning, and hypnotic consumption, and no difference in any measures between electroacupuncture and minimal acupuncture.ConclusionCompared with placebo acupuncture, electroacupuncture and minimal acupuncture resulted in greater improvement in subjective sleep measures at 1 week and 4 week post-treatment. No significant difference was found between electroacupuncture and minimal acupuncture, suggesting that the observed differences could be due to nonspecific effects of needling, regardless of whether it is done according to traditional Chinese medicine theory.

Dataset Information

A randomized controlled trial of intranasal ketamine in major depressive disorder.

Publications

A randomized controlled trial of intranasal ketamine in major depressive disorder.

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