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Tytuł:
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Ketamine versus midazolam in bipolar depression with suicidal thoughts: A pilot midazolam-controlled randomized clinical trial.
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Autorzy:
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Grunebaum MF; Molecular Imaging and Neuropathology Division, Department of Psychiatry, Columbia University Medical Center (CUMC) and New York State Psychiatric Institute, New York, NY, USA.
Ellis SP; Molecular Imaging and Neuropathology Division, Department of Psychiatry, Columbia University Medical Center (CUMC) and New York State Psychiatric Institute, New York, NY, USA.
Keilp JG; Molecular Imaging and Neuropathology Division, Department of Psychiatry, Columbia University Medical Center (CUMC) and New York State Psychiatric Institute, New York, NY, USA.
Moitra VK; Department of Anesthesiology, CUMC, New York, NY, USA.
Cooper TB; Analytical Psychopharmacology Laboratory, Nathan Kline Institute, Research Foundation for Mental Hygiene of New York State, Orangeburg, NY, USA.
Marver JE; Molecular Imaging and Neuropathology Division, Department of Psychiatry, Columbia University Medical Center (CUMC) and New York State Psychiatric Institute, New York, NY, USA.
Burke AK; Molecular Imaging and Neuropathology Division, Department of Psychiatry, Columbia University Medical Center (CUMC) and New York State Psychiatric Institute, New York, NY, USA.
Milak MS; Molecular Imaging and Neuropathology Division, Department of Psychiatry, Columbia University Medical Center (CUMC) and New York State Psychiatric Institute, New York, NY, USA.
Sublette ME; Molecular Imaging and Neuropathology Division, Department of Psychiatry, Columbia University Medical Center (CUMC) and New York State Psychiatric Institute, New York, NY, USA.
Oquendo MA; Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.
Mann JJ; Molecular Imaging and Neuropathology Division, Department of Psychiatry, Columbia University Medical Center (CUMC) and New York State Psychiatric Institute, New York, NY, USA.
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Źródło:
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Bipolar disorders [Bipolar Disord] 2017 May; Vol. 19 (3), pp. 176-183. Date of Electronic Publication: 2017 Apr 28.
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Typ publikacji:
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Journal Article; Randomized Controlled Trial
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Język:
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English
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Imprint Name(s):
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Publication: Copenhagen : Wiley-Blackwell Munksgaard
Original Publication: Copenhagen, Denmark : Munksgaard, 1999-
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MeSH Terms:
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Bipolar Disorder*/diagnosis
Bipolar Disorder*/drug therapy
Bipolar Disorder*/psychology
Ketamine*/administration & dosage
Ketamine*/adverse effects
Midazolam*/administration & dosage
Midazolam*/adverse effects
Suicidal Ideation*
Memory/*drug effects
Adult ; Anesthetics, Dissociative/administration & dosage ; Anesthetics, Dissociative/adverse effects ; Biomarkers/analysis ; Brain-Derived Neurotrophic Factor/analysis ; Dose-Response Relationship, Drug ; Double-Blind Method ; Drug Monitoring/methods ; Female ; GABA Modulators/administration & dosage ; GABA Modulators/adverse effects ; Humans ; Male ; Middle Aged ; Treatment Outcome
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Contributed Indexing:
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Keywords: bipolar disorder; depression; ketamine; midazolam; suicidal ideation
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Substance Nomenclature:
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0 (Anesthetics, Dissociative)
0 (Biomarkers)
0 (Brain-Derived Neurotrophic Factor)
0 (GABA Modulators)
690G0D6V8H (Ketamine)
7171WSG8A2 (BDNF protein, human)
R60L0SM5BC (Midazolam)
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Entry Date(s):
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Date Created: 20170429 Date Completed: 20180222 Latest Revision: 20220331
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Update Code:
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20240105
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DOI:
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10.1111/bdi.12487
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PMID:
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28452409
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Objectives: To evaluate feasibility and effects of a sub-anesthetic infusion dose of ketamine versus midazolam on suicidal ideation in bipolar depression. Neurocognitive, blood and saliva biomarkers were explored.
Methods: Sixteen participants with bipolar depression and a Scale for Suicidal Ideation (SSI) score of ≥4 were randomized to ketamine (0.5 mg/kg) or midazolam (0.02 mg/kg). Current pharmacotherapy was maintained excluding benzodiazepines within 24 hours. The primary clinical outcome was SSI score on day 1 post-infusion.
Results: Results supported feasibility. Mean reduction of SSI after ketamine infusion was almost 6 points greater than after midazolam, although this was not statistically significant (estimate=5.84, SE=3.01, t=1.94, P=.074, 95% confidence interval ([CI)]=-0.65 to 12.31). The number needed to treat for response (SSI <4 and at least 50% below baseline) was 2.2, and for remission (SSI=0) was 3.2. The strongest neurocognitive correlation was between memory improvement on the Selective Reminding Test (SRT) and reduction in SSI score on day 1 after ketamine (ρ=-.89, P=.007). Pre- to post-infusion decrease in serum brain derived neurotrophic factor (BDNF) correlated with reduction in SSI from baseline to day 1 after ketamine (n=5, ρ=0.90, P=.037) but not midazolam (P=.087).
Conclusions: The study demonstrated feasibility. Suicidal thoughts were lower after ketamine than after midazolam at a trend level of significance, likely due to the small pilot sample. Memory improvement and BDNF are promising biomarkers. Replication is needed in an adequately powered full-scale trial.
(© 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)
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