Clinical TrialParallelKetaminePlaceboCompleted

A Double-Blind Randomized Controlled Trial Using a Low Dose of Ketamine vs Active Placebo in Treating Severe Depression and Suicide

Parallel randomized double-blind trial of a single IV infusion of ketamine 0.5 mg/kg vs midazolam 0.045 mg/kg (active placebo) in adults 20–65 with treatment-resistant depression and prominent suicidal ideation. Target enrollment: 48. Primary outcome: rate of reduction in suicide symptoms post-infusion. Conducted at Taipei Veterans General Hospital, Taiwan. Funded by the Ministry of Science and Technology.

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Target Enrollment
48 participants
Study Type
Phase II interventional
Design
Randomized, double Blind

Study Arms & Interventions

Ketamine

experimental

Single IV infusion of ketamine 0.5 mg/kg over 40 minutes

Interventions

  • Ketamine0.5 mg/kg
    via IV• single dose

    Low-dose IV infusion over 40 minutes

Midazolam

active comparator

Single IV infusion of midazolam 0.045 mg/kg over 40 minutes (active placebo)

Interventions

  • Placebo0.045 mg/kg
    via IV• single dose

    Midazolam 0.045 mg/kg IV over 40 minutes (active placebo)

Study Details

  • Status
    Completed
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment48 participants
  • Timeline
    Start: 2018-08-15
    End: 2021-11-18
  • Compounds
    KetaminePlacebo

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A pilot randomized controlled trial of ketamine in Borderline Personality Disorder

This randomised controlled trial (n=22) is the first to study ketamine (35mg/70kg) in Borderline (BPD) in a placebo-controlled study. The study didn't report statistically significant differences between the ketamine and midazolam (active placebo) groups, though it did show a positive trend.

Published
Journal
Neuropsychopharmacology
Authors
Fineberg, S. K., Choi, E. Y., Shapiro-Thompson, R., Dhaliwal, K., Neustadter, E., Sakheim, M., Null, K., Trujillo-Diaz, D., Rondeau, J., Pittaro, G. F., Peters, J. R., Corlett, P. R., Krystal, J. H.
Open AccessindividualPrimary

A Randomized Double-Blind Midazolam-Controlled Trial of Low-Dose Ketamine Infusion in Patients With Treatment-Resistant Depression and Prominent Suicidal Ideation

In this randomized double‑blind trial of 84 outpatients with treatment‑resistant depression and prominent suicidal ideation, a single low‑dose ketamine infusion (35mg/70kg) produced greater antidepressant effects than midazolam lasting up to 14 days and antisuicidal effects lasting about 5 days. Benefits were most evident in patients whose current episode was under 24 months or who had failed ≤4 antidepressants, and the infusion was safe and well tolerated.

Published
Journal
International Journal of Neuropsychopharmacology
Authors
Su, T. P., Li, C. T., Lin, W. C., Wu, H. J., Tsai, S. J., Bai, Y. M., Mao, W. C., Tu, P. C., Chen, L. F., Li, W. C., Chen, M. H.