Phase 4
Completed N=82
Ketamine in the Treatment of Suicidal Depression
Source: ClinicalTrials.gov NCT01700829 ↗Enrolled (actual)
82
Serious AEs
11.3%
Results posted
Mar 2020
Primary outcomePrimary: Change in Scale for Suicidal Ideation — -3.66; -8.62 units on a scale
◆ Published Evidence
Highly cited
428citations · ~54 / year
Ketamine for Rapid Reduction of Suicidal Thoughts in Major Depression: A Midazolam-Controlled Randomized Clinical Trial.
Summary
This study is designed to compare the effectiveness of two medications, Ketamine and Midazolam, for rapidly relieving suicidal thoughts in people suffering from depression.
The first drug, Ketamine, is an experimental antidepressant that early studies have shown may quickly reduce suicidal thoughts, but we are not sure how well it may work. Midazolam, the comparison drug, is not thought to reduce depression or suicidal thoughts.
Linked Publications (4)
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Ketamine for Rapid Reduction of Suicidal Thoughts in Major Depression: A Midazolam-Controlled Randomized Clinical Trial.
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Effects of Ketamine Versus Midazolam on Neurocognition at 24 Hours in Depressed Patients With Suicidal Ideation.
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Ketamine vs midazolam: Mood improvement reduces suicidal ideation in depression.
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Computerized-Adaptive vs. Traditional Ratings of Depression and Suicidal Thoughts: An Assay Sensitivity Pilot Study in a Ketamine Clinical Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Scale for Suicidal Ideation |
-3.66; -8.62 | — |
| SECONDARY Saliva Cortisol Awakening Response (CAR). |
0.94; 0.47; 1.29; 0.88; 0.77; 0.74 | — |
| SECONDARY Neuropsychological Effects |
-0.252; -0.306; -0.146; -0.01 | — |
Eligibility Criteria
INCLUSION CRITERIA
- Unipolar depression with current major depressive episode (MDE). Participants may be psychiatric medication-free, or if on psychiatric medication, not responding adequately given current MDE with suicidal ideation (See 2).
- Moderate to severe suicidal ideation
- 18-65 years old
- Participants must agree to a voluntary admission to an inpatient research unit at the New York State Psychiatric Institute (NYSPI)for the infusion(s), for a brief stay, or longer if clinically necessary.
- Pre-menopausal female participants of child-bearing potential must be willing to use an acceptable form of birth control during study participation such as condoms, diaphragm, or oral contraceptive pills.
- Able to provide informed consent
- Participants 61-65 years old must score a 25 or higher on the Mini-Mental State Examination (MMSE) at screening.
EXCLUSION CRITERIA
- Unstable medical condition or neurological illness, including baseline hypertension (BP>140/90) or significant history of cardiovascular illness.
- Significant ECG abnormality
- Pregnant or lactating
- Diagnosis of bipolar disorder or psychotic disorder
- Contraindication to any study treatment.
- Inadequate understanding of English.
- Prior ineffective trial of or adverse reaction to Ketamine or Midazolam.
- Opiate use greater than total daily dose of 20mg Oxycodone or equivalent during the 3 days pre-infusion.
- A diagnosis of sleep apnea.
Data sourced from ClinicalTrials.gov (NCT01700829) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.