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Ketamine for Suicidality in Bipolar Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01944293
Recruitment Status : Completed
First Posted : September 17, 2013
Results First Posted : June 6, 2019
Last Update Posted : March 11, 2020
Sponsor:
Collaborator:
Brain & Behavior Research Foundation
Information provided by (Responsible Party):
Michael Grunebaum, MD, New York State Psychiatric Institute

Tracking Information
First Submitted Date  ICMJE September 8, 2013
First Posted Date  ICMJE September 17, 2013
Results First Submitted Date  ICMJE October 3, 2018
Results First Posted Date  ICMJE June 6, 2019
Last Update Posted Date March 11, 2020
Study Start Date  ICMJE September 2013
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2019)
Change in Suicidal Ideation Measured With the Beck Scale for Suicidal Ideation [ Time Frame: At 24 hours post-Infusion ]
Change in suicidal ideation in Bipolar Disorder during a Major Depressive Episode (MDE), with moderate to severe suicidal thoughts, from the pre-infusion baseline to 24 hours after the infusion of Ketamine (study drug) or Midazolam (active control).
Original Primary Outcome Measures  ICMJE
 (submitted: September 12, 2013)
Reduction of Suicidal Ideation measured with the Beck Scale for Suicidal Ideation [ Time Frame: At 24 hours post-Infusion ]
Reduction of suicidal ideation in Bipolar Disorder during a Major Depressive Episode (MDE), with moderate to severe suicidal thoughts, from the pre-infusion baseline to 24 hours after the infusion with Ketamine or Midazolam, a sedative not known to reduce suicidal ideation.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2019)
Change in Systolic Blood Pressure [ Time Frame: During study infusion ]
Blood pressure is measured in millimeters of mercury.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2013)
Adverse events [ Time Frame: 24 hours post-infusion ]
Number of subjects with adverse events.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine for Suicidality in Bipolar Depression
Official Title  ICMJE Ketamine vs. Midazolam in Bipolar Depression
Brief 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.

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.

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). After the infusion(s), participants will have weekly research interviews for 6 weeks to monitor response.

After post-infusion research measures are completed, all subjects will receive open clinical treatment. During open clinical treatment, medication will be changed for those patients who don't respond or whose response is transient.

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 combining inpatient and outpatient treatment. At the end of the 6 months of treatment patients will be referred for ongoing care.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Bipolar Disorder
  • Major Depressive Episode
  • Suicidal Ideation
Intervention  ICMJE
  • Drug: Ketamine
    Single dose of 0.5 mg/kg of Ketamine given intravenously (in the vein) over 40 minutes
    Other Names:
    • Ketalar
    • Ketamine Hydrochloride Injection
  • Drug: Midazolam
    Single dose of 0.02 mg/kg of Midazolam given intravenously (in the vein) over 40 minutes
    Other Name: Midazolam Injection
Study Arms  ICMJE
  • Experimental: Ketamine
    0.5 mg/kg, I.V. (in the vein)
    Intervention: Drug: Ketamine
  • Active Comparator: Midazolam
    0.02 mg/kg, I.V. (in the vein)
    Intervention: Drug: Midazolam
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 6, 2017)
16
Original Estimated Enrollment  ICMJE
 (submitted: September 12, 2013)
30
Actual Study Completion Date  ICMJE October 2018
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01944293
Other Study ID Numbers  ICMJE #6785
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael Grunebaum, MD, New York State Psychiatric Institute
Study Sponsor  ICMJE New York State Psychiatric Institute
Collaborators  ICMJE Brain & Behavior Research Foundation
Investigators  ICMJE
Principal Investigator: Michael F Grunebaum, M.D. Columbia Unviversity/New York State Psychiatric Institute
PRS Account New York State Psychiatric Institute
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP