Table 3 Study characteristics: Open label R-ketamine trials.

From: Clinical trials since 2020 of rapid anti-suicidal ideation effects of ketamine and its enantiomers: a systematic review

Reference

Study Design; Country; Registration

Sample size (intervention vs control, if applicable)

Control Drug (if applicable)

Population

Intervention

Measure of suicidal ideation or behavior

Main Findings

Bandeira et al. [24]

Open-label pilot trial; Brazil UMIN000042201a

6

N/A

18–65 y/o inpatient and outpatients with depressive episode ( ≥ 4 weeks in duration), type I and II bipolar disorder without psychotic features, a YMRSb of 12 or less at baseline; a MADRSc of at least 25

IV R-ketamine (0.5 mg/kg) administered over 40 min. After one week, IV R-ketamine (1 mg/kg) over 40 min

MADRSc item 10

Rapid-acting antidepressant response with 50% improvement one day after the 1.0 mg/kg dose. SI decreased by 60% without severe adverse effects, dissociation, and manic symptoms

Leal et al. [22]

Open label, pilot-study; Brazil; UMIN000038347d

7

N/A

18–65 y/o inpatients and outpatients with MDD, MADRSc score of at least 25, and failure to respond to at least 2 antidepressant trials in current episode.

Single infusion of IV R-ketamine (0.5 mg/kg) over 40 min

Did not measure suicidal ideation. Depression was measured using the MADRSc. The CADSSd measured dissociative symptoms.

Fast-onset and sustained antidepressant effects from 60 min up to 240 min post-infusion. Limited dissociative symptoms and adverse effects.

  1. aIt is unclear if the UMIN is correct. This registration number lists a randomized, double-blind, placebo-controlled trial when the paper categorizes the study as an open-label trial.
  2. bYoung Mania Rating Scale (YMRS) [74].
  3. cMontgomery-Asberg Depression Rating Scale. Item 10 in particular examines suicidal thoughts, and preparations for suicide [30].
  4. dIt is unclear if the UMIN is correct. This registration number is the same as that listed for Leal et al. [23], a randomized controlled trial.
  5. eClinician-Administered Dissociative States Scale [75].
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