Acute DepressionPhase 1NCT02378415
Subanesthetic IV Bolus Ketamine in the Treatment of Acute Depression
A Phase 1 study testing Ketamine in people with Acute Depression, run by United States Naval Medical Center, San Diego at 1 site in United States.
Trial summary
The objective of this double-blinded placebo-controlled pilot study is to determine whether a single sub-anesthetic rapid IV bolus dose of ketamine administered to acutely depressed patients with or without suicidality has a significant rapid antidepressant effect in the acutely depressed population. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Depression
- What is being tested?
- Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Jun 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BSS greater than 4
- BHS greater than 8
- BDI greater than 19
- Ability to give informed consent.
- Active Duty military status.
- Verified negative qualitative pregnancy test.
- All participants must be accepted for psychiatric admission to the hospital PRIOR to consideration for enrollment in this study.
Who cannot join
- Psychosis or Bipolar Disorder.
- Pregnancy
- Involuntary Status on presentation to the ED.
- UDS positive for illicit drugs of abuse.
- Blood Alcohol level greater than zero.
- Previous enrollees in this treatment protocol will be excluded from repeat participation.
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- Any patient brought for command directed psychiatric evaluation.
- Specific contraindications to the use of ketamine are as follows and under such circumstances or conditions, personnel with the following should be excluded from participation in this study:
- Patients with elevated intracranial pressure, uncontrolled hypertension, coronary artery disease, aneurysms, thyrotoxicosis, CHF, a recent history of head or eye injury, or angina.
- All personnel in whom a significant elevation of blood pressure would constitute a serious hazard to their overall health and well-being.
- Patients currently utilizing the following medications: conivaptan, Disatinib, peginterferon alfa-2b, quazepam, tocilizumab
Trial locations and contacts
1 site in 1 country.
United States1 site
Naval Medical Center San Diego
San Diego, California, 92134
About this study
The objective of this double-blinded placebo-controlled pilot study is to determine whether a single sub-anesthetic rapid IV bolus dose of ketamine administered to acutely depressed patients with or without suicidality has a significant rapid antidepressant effect in the acutely depressed population. The study will pursue as a primary outcome measure whether a significant reduction in depressive symptoms, as assessed by the BSS and BHS, occurs shortly after administration of ketamine at 40, 80, 120, and 240 minutes. A secondary outcome measure will be assessed to determine whether this single infusion of ketamine has a sustained reduction in depressive symptoms within 2-weeks post-infusion with a reduction in BDI score. Suicidal ideation will also be assessed for determination of any reduction and sustained reduction post infusion by assessment of the Beck Suicidal Ideation Scale (BSS), Beck Hopelessness Scale (BHS) and Beck Depression Inventory (BDI) at similar intervals.
Read the detailed description
A determination for hospital admittance by a consulting psychiatrist will be made prior to study participation. Only those persons being admitted to the psychiatric ward will be eligible to enroll in this study. After consenting to participate in the trial and meeting inclusion criteria for this study (to include a baseline BDI, BSS, and BHS), voluntarily presenting acutely depressed patients, with or without suicidal ideation, will be randomized into two groups and administered standard of care treatment with intravenous ketamine (0.2mg/kg over 1-2 minutes) or standard of care treatment with intravenous normal saline (equal volume to ketamine dose). All prepared study solutions will be mixed and administered by ED staff and/or nursing staff as per the existing NMCSD ED protocols. All subjects will be blinded to the treatment given, either an IV bolus dose of ketamine at 0.2-mg/kg over 1-2 minutes or a placebo solution composed of an equal IV bolus dose (by overall volume) of 0.9 normal saline solution will be administered. Thereafter, all patients will be evaluated clinically with a BSS, BHS, and BDI at 40, 80, 120, and 240 minutes. All study participants will be monitored medically in the ED for at least the full 240-minute protocol and once declared medically clear, in accordance with standard of care practices by the ED providers, will be transferred to the inpatient psychiatric ward for further monitoring for at least 24-hours prior to discharge from the hospital. All enrolled patients will be administered another BSS, BHS, and BDI prior to discharge from the hospital. The length of hospital stay will also be recorded for further analysis, but will not be considered a secondary outcome measure for this study. Psychiatric determination for discharge from the hospital will be based on clinical assessment, presentation history, and hospital course and is not considered an outcome measure for this study. All patients included in this study will be re-assessed within 2 weeks with another BSS, BHS, and BDI for determination of sustainability of effects. Appropriate follow-up care with a psychiatrist will be afforded to all study participants after discharge from the hospital. Additionally, should any severe adverse side effects develop; the treatment administered to enrolled patients may be un-blinded by a third-party shift medical monitor (i.e. the Charge Nurse) on request from the emergency room provider. Additionally, given the potential psychotropic effects of ketamine and to assure that patients are sufficiently monitored and appropriately medically cleared, all participants in the study will be required to remain under clinical observation in the emergency room prior to transfer to the psychiatric ward for, at least, the full 4-hour treatment cycle or longer as clinically indicated. All participants in this study will only be allowed to enroll in this study and undergo this protocol's treatment once.
- Conditions
- Acute Depression
- Being tested
- Ketamine, Placebo
- Keywords
- Depression
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Also called Ketalor.
IV Bolus dose of ketamine dosed at 0.2mg/kg infused over 1-2 minutes.
PlaceboDrug
Normal Saline Infusion
| Study group | Role | What they receive |
|---|---|---|
| Normal Saline Infusion | Placebo comparator | A single IV bolus dose of normal saline solution. Receives: Drug: Placebo |
| Subanesthetic IV Bolus Ketamine | Experimental | a single sub-anesthetic rapid IV bolus dose of ketamine administered to acutely depressed patients with or without suicidality Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suicidality
Beck Suicidal Ideation Scale (BSS)
Measured: Baseline
Secondary outcomes (2)
Depression
Beck Depression Index (BDI)
Measured: Baseline, 40-minutes, 80-minutes, 120-minutes, 240-minutes, exit at discharge, and at follow-up within 2-weeks
Hopelessness
Beck Hopelessness Scale
Measured: Baseline, 40-minutes, 80-minutes, 120-minutes, 240-minutes, exit at discharge, and at follow-up within 2-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study startDec 2011
- Primary completionJun 2013
- Study completionJun 2013
Why it stopped: Discrepancies in medication orders
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute DepressionStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Naval Medical Center, San Diego
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Robert E Lovern, MD, Principal investigator, United States Naval Medical Center, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02378415
- Sponsor's protocol ID
- NMCSD.2011.0063
- Status last verified
- Feb 2015
- First submitted
- 15 Aug 2012
- Last updated
- 4 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subanesthetic IV Bolus Ketamine in the Treatment of Acute Depression
- ClinicalTrials.gov ID
- NCT02378415
- Acronym / sponsor ID
- NMCSD.2011.0063
- Conditions
- Acute Depression
- Keywords
- Depression
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Discrepancies in medication orders
- Enrolment
- 20 participants (actual)
- Lead sponsor
- United States Naval Medical Center, San DiegoUS federal agency
- Study start
- Dec 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 4 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this double-blinded placebo-controlled pilot study is to determine whether a single sub-anesthetic rapid IV bolus dose of ketamine administered to acutely depressed patients with or without suicidality has a significant rapid antidepressant effect in the acutely depressed population. The study will pursue as a primary outcome measure whether a significant reduction in depressive symptoms, as assessed by the BSS and BHS, occurs shortly after administration of ketamine at 40, 80, 120, and 240 minutes. A secondary outcome measure will be assessed to determine whether this single infusion of ketamine has a sustained reduction in depressive symptoms within 2-weeks post-infusion with a reduction in BDI score. Suicidal ideation will also be assessed for determination of any reduction and sustained reduction post infusion by assessment of the Beck Suicidal Ideation Scale (BSS), Beck Hopelessness Scale (BHS) and Beck Depression Inventory (BDI) at similar intervals.
Detailed description
A determination for hospital admittance by a consulting psychiatrist will be made prior to study participation. Only those persons being admitted to the psychiatric ward will be eligible to enroll in this study. After consenting to participate in the trial and meeting inclusion criteria for this study (to include a baseline BDI, BSS, and BHS), voluntarily presenting acutely depressed patients, with or without suicidal ideation, will be randomized into two groups and administered standard of care treatment with intravenous ketamine (0.2mg/kg over 1-2 minutes) or standard of care treatment with intravenous normal saline (equal volume to ketamine dose). All prepared study solutions will be mixed and administered by ED staff and/or nursing staff as per the existing NMCSD ED protocols. All subjects will be blinded to the treatment given, either an IV bolus dose of ketamine at 0.2-mg/kg over 1-2 minutes or a placebo solution composed of an equal IV bolus dose (by overall volume) of 0.9 normal saline solution will be administered. Thereafter, all patients will be evaluated clinically with a BSS, BHS, and BDI at 40, 80, 120, and 240 minutes. All study participants will be monitored medically in the ED for at least the full 240-minute protocol and once declared medically clear, in accordance with standard of care practices by the ED providers, will be transferred to the inpatient psychiatric ward for further monitoring for at least 24-hours prior to discharge from the hospital. All enrolled patients will be administered another BSS, BHS, and BDI prior to discharge from the hospital. The length of hospital stay will also be recorded for further analysis, but will not be considered a secondary outcome measure for this study. Psychiatric determination for discharge from the hospital will be based on clinical assessment, presentation history, and hospital course and is not considered an outcome measure for this study. All patients included in this study will be re-assessed within 2 weeks with another BSS, BHS, and BDI for determination of sustainability of effects. Appropriate follow-up care with a psychiatrist will be afforded to all study participants after discharge from the hospital. Additionally, should any severe adverse side effects develop; the treatment administered to enrolled patients may be un-blinded by a third-party shift medical monitor (i.e. the Charge Nurse) on request from the emergency room provider. Additionally, given the potential psychotropic effects of ketamine and to assure that patients are sufficiently monitored and appropriately medically cleared, all participants in the study will be required to remain under clinical observation in the emergency room prior to transfer to the psychiatric ward for, at least, the full 4-hour treatment cycle or longer as clinically indicated. All participants in this study will only be allowed to enroll in this study and undergo this protocol's treatment once.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Saline Infusion | Placebo comparator | Drug: PlaceboA single IV bolus dose of normal saline solution. |
| Subanesthetic IV Bolus Ketamine | Experimental | Drug: Ketaminea single sub-anesthetic rapid IV bolus dose of ketamine administered to acutely depressed patients with or without suicidality |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- BSS greater than 4
- BHS greater than 8
- BDI greater than 19
- Ability to give informed consent.
- Active Duty military status.
Key exclusion criteria (11 listed)
- Psychosis or Bipolar Disorder.
- Pregnancy
- Involuntary Status on presentation to the ED.
- UDS positive for illicit drugs of abuse.
- Blood Alcohol level greater than zero.
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: Ketalor.IV Bolus dose of ketamine dosed at 0.2mg/kg infused over 1-2 minutes. | Drug | Subanesthetic IV Bolus Ketamine |
| PlaceboNormal Saline Infusion | Drug | Normal Saline Infusion |
Primary outcome
Suicidality
Time frame: Baseline
Beck Suicidal Ideation Scale (BSS)
2 secondary outcomes
Depression
Time frame: Baseline, 40-minutes, 80-minutes, 120-minutes, 240-minutes, exit at discharge, and at follow-up within 2-weeks
Hopelessness
Time frame: Baseline, 40-minutes, 80-minutes, 120-minutes, 240-minutes, exit at discharge, and at follow-up within 2-weeks
Results and safety
The study was stopped early (reason given: Discrepancies in medication orders). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2015.
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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.
Robert E Lovern, MD principal investigator
United States Naval Medical Center, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ketamine in people with Acute Depression, run by United States Naval Medical Center, San Diego 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 11 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: stopped early, as of the sponsor's last update on 4 Mar 2015. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Discrepancies in medication orders). Results are not available in the source record.
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?
Suicidality (time frame: Baseline). 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 4 Mar 2015.