Ketamine in the Treatment of Suicidal Depression
Information source: New York State Psychiatric Institute
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Major Depressive Disorder; Suicidal Ideation
Intervention: Ketamine (Drug); Midazolam (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: New York State Psychiatric Institute Official(s) and/or principal investigator(s): Michael F. Grunebaum, M.D., Principal Investigator, Affiliation: Columbia University/New York State Psychiatric Institute
Overall contact: Julia E Marver, B.A., Phone: (646) 774-7627, Email: marverj@nyspi.columbia.edu
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.
Clinical Details
Official title: Ketamine vs. Midazolam: Testing Rapid Relief of Suicide Risk in Depression
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Reduction of suicidal ideation
Secondary outcome: Effects on saliva stress hormone (cortisol)Neuropsychological effects
Detailed description:
Patients currently taking psychiatric medications may continue them during the study.
However, if a patient is taking a benzodiazepine (such as Ativan, Klonopin, or Xanax), they
will be able to take up to 2mg per day of Lorazepam during the week before the infusion, but
none will be permitted in the 24 hours pre-infusion. Also, Zolpidem (Ambien) will not be
permitted in the 24 hours pre-infusion. If a person chooses to participate, their dose of
benzodiazepine may need to be reduced so that they can do without it during the 24 hours
pre-infusion.
Depressed participants are randomly assigned to receive a single dose of Ketamine(0. 5 mg/kg)
or Midazolam (0. 02 mg/kg), which is given slowly, in a vein, over about 40 minutes. The
study is "double-blind," meaning patients and study staff will not know which medication is
in the infusion.
If a patient does not respond to the first infusion, and s/he received Midazolam, then s/he
will be offered the option of a second infusion, this time with Ketamine (0. 5 mg/kg). S/he
will then start treatment with a standard antidepressant, unless s/he is not already taking
one.
After the infusion(s), participants will have weekly research interviews for 6 weeks to
monitor response.
If a patient does have a sufficient infusion response, and s/he is not already taking an
antidepressant, then s/he will receive 6-weeks antidepressant research treatment with
Sertraline, Fluoxetine, Paroxetine, or Escitalopram, followed by open clinical treatment.
However, if s/he is already taking an antidepressant, then s/he will receive open treatment.
If s/he does not have a sufficient infusion response, then s/he will receive open treatment.
Participation in this study requires a brief inpatient stay, at no cost, at the New York
State Psychiatric Institute (NYSPI).
Eligible participants enrolled in this study will be offered medication management visits at
no cost for a total of up to 6 months from the date of enrollment combining inpatient and
outpatient treatment. Study medications (Sertraline, Fluoxetine, Paroxetine, Escitalopram,
Lorazepam, Zolpidem) will be at no cost during the 6 months. The study will not provide
other medications at no cost.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
Julia E Marver, B.A., Phone: (646) 774-7627, Email: marverj@nyspi.columbia.edu
Columbia University/New York State Psychiatric Institute, New York, New York 10032, United States; Recruiting Julia E Marver, B.A., Phone: 646-774-7627, Email: marverj@nyspi.columbia.edu Michael F. Grunebaum, M.D., Principal Investigator
Additional Information
Columbia University Medical Center Psychiatry Additional Information Channel 7 NYC Story about Ketamine Research at Columbia University Medical Center MIND Clinic for Mood and Personality Disorders
Starting date: June 2012
Last updated: April 16, 2015
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