Assessing measures of suicidal ideation in clinical trials with a rapid-acting antidepressant

Elizabeth D Ballard; David A Luckenbaugh; Erica M Richards; Tessa L Walls; Nancy E Brutsché; Rezvan Ameli; Mark J Niciu; Jennifer L Vande Voort; Carlos A Zarate Jr

doi:10.1016/j.jpsychires.2015.06.003

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Assessing measures of suicidal ideation in clinical trials with a rapid-acting antidepressant

Journal article

Peer reviewed

Assessing measures of suicidal ideation in clinical trials with a rapid-acting antidepressant

Elizabeth D Ballard, David A Luckenbaugh, Erica M Richards, Tessa L Walls, Nancy E Brutsché, Rezvan Ameli, Mark J Niciu, Jennifer L Vande Voort and Carlos A Zarate Jr

Journal of psychiatric research, Vol.68, pp.68-73

09/2015

DOI: 10.1016/j.jpsychires.2015.06.003

PMCID: PMC4522045

PMID: 26228403

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Abstract

Rapid reduction of suicidal thoughts is critical for treating suicidal patients. Clinical trials evaluating these treatments require appropriate measurement. Key methodological issues include: 1) the use of single or multi-item assessments, and 2) evaluating whether suicidal ideation measures can track rapid change over time. The current study presents data from two randomized, placebo-controlled, crossover clinical trials evaluating ketamine in individuals with treatment-resistant depression (n = 60). Participants were assessed for suicidal thoughts using the Hamilton Depression Rating Scale (HAM-D), Montgomery-Asberg Depression Rating Scale (MADRS), Beck Depression Inventory (BDI), and Scale for Suicidal Ideation (SSI) at eight time points over three days. Assessments were compared using correlational analyses and effect sizes at 230 min and three days after ketamine infusion. Linear mixed models evaluated change in ideation across all time points. The HAM-D and MADRS suicide items demonstrated correlations of r > .80 with the first five items of the SSI (SSI5). On linear mixed models, an effect for ketamine was found for the HAM-D, MADRS, BDI items, and SSI5 (p < .001), but not for the full SSI (p = .88), which suggests a limited ability to assess change over time in patients with low levels of suicidal thoughts. Taken together, the results suggest that repeated suicidal assessments over minutes to days appear to detect improvement in suicidal thoughts after ketamine infusion compared to placebo. The MADRS suicide item, BDI suicide item, and SSI5 may be particularly sensitive to rapid changes in suicidal thoughts.

Clozapine - therapeutic use

Humans

Middle Aged

Male

Suicidal Ideation

Statistics as Topic

Bipolar Disorder - drug therapy

Bipolar Disorder - psychology

Randomized Controlled Trials as Topic

Antidepressive Agents - therapeutic use

Cross-Over Studies

Depressive Disorder, Major - psychology

Young Adult

Psychiatric Status Rating Scales

Ketamine

Time Factors

Adolescent

Adult

Female

Aged

Depressive Disorder, Major - drug therapy

Details

Title: Subtitle: Assessing measures of suicidal ideation in clinical trials with a rapid-acting antidepressant
Creators: Elizabeth D Ballard - Experimental Therapeutics & Pathophysiology Branch, Intramural Research Program, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, 20892, USA. Electronic address: Elizabeth.Ballard@nih.gov
David A Luckenbaugh - Experimental Therapeutics & Pathophysiology Branch, Intramural Research Program, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, 20892, USA. Electronic address: luckenbd@mail.nih.gov
Erica M Richards - Experimental Therapeutics & Pathophysiology Branch, Intramural Research Program, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, 20892, USA. Electronic address: erica.richards@nih.gov
Tessa L Walls - Experimental Therapeutics & Pathophysiology Branch, Intramural Research Program, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, 20892, USA. Electronic address: tessa.walls@nih.gov
Nancy E Brutsché - Experimental Therapeutics & Pathophysiology Branch, Intramural Research Program, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, 20892, USA. Electronic address: brutschn@mail.nih.gov
Rezvan Ameli - Experimental Therapeutics & Pathophysiology Branch, Intramural Research Program, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, 20892, USA. Electronic address: amelir@mail.nih.gov
Mark J Niciu - Experimental Therapeutics & Pathophysiology Branch, Intramural Research Program, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, 20892, USA. Electronic address: mark.niciu@nih.gov
Jennifer L Vande Voort - Experimental Therapeutics & Pathophysiology Branch, Intramural Research Program, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, 20892, USA. Electronic address: VandeVoort.Jennifer@mayo.edu
Carlos A Zarate Jr - Experimental Therapeutics & Pathophysiology Branch, Intramural Research Program, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, 20892, USA. Electronic address: zaratec@mail.nih.gov
Resource Type: Journal article
Publication Details: Journal of psychiatric research, Vol.68, pp.68-73
DOI: 10.1016/j.jpsychires.2015.06.003
PMID: 26228403
PMCID: PMC4522045
NLM abbreviation: J Psychiatr Res
ISSN: 0022-3956
eISSN: 1879-1379
Publisher: Elsevier BV; England
Grant note: Z99 MH999999 / Intramural NIH HHS
Language: English
Date published: 09/2015
Academic Unit: Psychiatry; Iowa Neuroscience Institute
Record Identifier: 9984004183302771

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