Phase 2
N=16
Ketamine for Suicidality in Bipolar Depression
Bipolar Disorder · Major Depressive Episode · Suicidal Ideation
Bottom Line
View on ClinicalTrials.gov: NCT01944293 ↗Enrolled (actual)
16
Serious AEs
25.0%
Results posted
Jun 2019
Primary outcome: Primary: Change in Suicidal Ideation Measured With the Beck Scale for Suicidal Ideation — -12.4; -6.7 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ketamine (Drug); Midazolam (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- New York State Psychiatric Institute
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Suicidal Ideation Measured With the Beck Scale for Suicidal Ideation |
-12.4; -6.7 | — |
| SECONDARY Change in Systolic Blood Pressure |
23; 3 | — |
Summary
This study is designed to compare the effectiveness of two medications, Ketamine and Midazolam, for rapidly relieving suicidal thoughts in people suffering from bipolar 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
- Bipolar 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.
- Moderate to severe suicidal ideation
- 18-65 years old
- Patients will only be enrolled if they agree to voluntary admission to an inpatient research unit at the New York State Psychiatric Institute (NYSPI) for infusion phase of treatment.
- 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, oral contraceptive pills
- Able to provide informed consent
- Subjects 61-65 years old must score 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
- Pregnancy and/or lactation
- Current psychotic symptoms
- Contraindication to any study treatment
- Current or past ketamine abuse or dependence ever (lifetime); any other drug or alcohol dependence within past 6 months; suicidality only due to binge substance use or withdrawal
- 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
Data sourced from ClinicalTrials.gov (NCT01944293). 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.