Bipolar DisorderPhase 1/2NCT01944293
Ketamine for Suicidality in Bipolar Depression
A Phase 1/2 study testing Ketamine and Midazolam in people with Bipolar Disorder and Major Depressive Episode, run by New York State Psychiatric Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder, Major Depressive Episode, Suicidal Ideation
- What is being tested?
- Ketamine and Midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Oct 2018
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University/New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: Ketamine vs. Midazolam in Bipolar Depression
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.
Read the 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.
- Keywords
- Ketamine, Midazolam, Bipolar Disorder, Major Depressive Episode, Suicidal Ideation, Suicide, Depression, Treatment, Ketamine Treatment
- Medical subject headings
- Bipolar Disorder, Suicidal Ideation, Suicide, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Also called Ketalar, Ketamine Hydrochloride Injection
Single dose of 0.5 mg/kg of Ketamine given intravenously (in the vein) over 40 minutes
MidazolamDrug
Also called Midazolam Injection
Single dose of 0.02 mg/kg of Midazolam given intravenously (in the vein) over 40 minutes
| Study group | Role | What they receive |
|---|---|---|
| Ketamine | Experimental | 0.5 mg/kg, I.V. (in the vein) Receives: Drug: Ketamine |
| Midazolam | Active comparator | 0.02 mg/kg, I.V. (in the vein) Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Suicidal Ideation Measured With the Beck Scale for Suicidal Ideation
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).
Measured: At 24 hours post-Infusion
Secondary outcomes (1)
Change in Systolic Blood Pressure
Blood pressure is measured in millimeters of mercury.
Measured: During study infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionSep 2017
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Brain & Behavior Research Foundation
- Responsible party
- Principal investigator, Michael Grunebaum, MD, New York State Psychiatric Institute
- Investigators
- Michael F Grunebaum, M.D., Principal investigator, Columbia Unviversity/New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01944293
- Sponsor's protocol ID
- #6785
- Status last verified
- Feb 2020
- First submitted
- 8 Sep 2013
- Last updated
- 11 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketamine vs. Midazolam in Bipolar Depression
- ClinicalTrials.gov ID
- NCT01944293
- Acronym / sponsor ID
- #6785
- Keywords
- Ketamine, Midazolam, Bipolar Disorder, Major Depressive Episode, Suicidal Ideation, Suicide, Depression, Treatment
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- Brain & Behavior Research Foundation
- Study start
- Sep 2013
- Primary completion
- Sep 2017 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 17 Sep 2013 (estimated)
- Results
- Posted 6 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine | Experimental | Drug: Ketamine0.5 mg/kg, I.V. (in the vein) |
| Midazolam | Active comparator | Drug: Midazolam0.02 mg/kg, I.V. (in the vein) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetamineAlso: Ketalar, Ketamine Hydrochloride InjectionSingle dose of 0.5 mg/kg of Ketamine given intravenously (in the vein) over 40 minutes | Drug | Ketamine |
| MidazolamAlso: Midazolam InjectionSingle dose of 0.02 mg/kg of Midazolam given intravenously (in the vein) over 40 minutes | Drug | Midazolam |
Primary outcome
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).
1 secondary outcome
Change in Systolic Blood Pressure
Time frame: During study infusion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- MIND Clinic for Mood and Personality DisordersLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael F Grunebaum, M.D. principal investigator
Columbia Unviversity/New York State Psychiatric Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ketamine and Midazolam in people with Bipolar Disorder and Major Depressive Episode, run by New York State Psychiatric Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Suicidal Ideation Measured With the Beck Scale for Suicidal Ideation (time frame: At 24 hours post-Infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2020.