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Ketamine for Suicidality in Bipolar Depression

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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

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.


Condition or disease Intervention/treatment Phase
Bipolar Disorder Major Depressive Episode Suicidal Ideation Drug: Ketamine Drug: Midazolam Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ketamine vs. Midazolam in Bipolar Depression
Study Start Date : September 2013
Actual Primary Completion Date : September 2017
Actual Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arm Intervention/treatment
Experimental: Ketamine
0.5 mg/kg, I.V. (in the vein)
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

Active Comparator: Midazolam
0.02 mg/kg, I.V. (in the vein)
Drug: Midazolam
Single dose of 0.02 mg/kg of Midazolam given intravenously (in the vein) over 40 minutes
Other Name: Midazolam Injection




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Change in Systolic Blood Pressure [ Time Frame: During study infusion ]
    Blood pressure is measured in millimeters of mercury.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01944293


Locations
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United States, New York
Columbia University/New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Brain & Behavior Research Foundation
Investigators
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Principal Investigator: Michael F Grunebaum, M.D. Columbia Unviversity/New York State Psychiatric Institute
  Study Documents (Full-Text)

Documents provided by Michael Grunebaum, MD, New York State Psychiatric Institute:
Statistical Analysis Plan  [PDF] May 14, 2019
Study Protocol  [PDF] July 1, 2019

Additional Information:
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Responsible Party: Michael Grunebaum, MD, Clinical Psychiatrist, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01944293    
Other Study ID Numbers: #6785
First Posted: September 17, 2013    Key Record Dates
Results First Posted: June 6, 2019
Last Update Posted: March 11, 2020
Last Verified: February 2020
Keywords provided by Michael Grunebaum, MD, New York State Psychiatric Institute:
Ketamine
Midazolam
Bipolar Disorder
Major Depressive Episode
Suicidal Ideation
Suicide
Depression
Treatment
Ketamine Treatment
Additional relevant MeSH terms:
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Depression
Bipolar Disorder
Suicidal Ideation
Behavioral Symptoms
Mental Disorders
Bipolar and Related Disorders
Suicide
Self-Injurious Behavior
Midazolam
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents