Phase 4
N=82
Ketamine in the Treatment of Suicidal Depression
Major Depressive Disorder · Suicidal Ideation
Bottom Line
View on ClinicalTrials.gov: NCT01700829 ↗Enrolled (actual)
82
Serious AEs
11.3%
Results posted
Mar 2020
Primary outcome: Primary: Change in Scale for Suicidal Ideation — -3.66; -8.62 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ketamine (Drug); Midazolam (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- New York State Psychiatric Institute
- Primary completion
- Jan 2017
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 | — |
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.
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). 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.