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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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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

Other trials in United States

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.

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 groups in NCT02378415
Study groupRoleWhat they receive
Normal Saline InfusionPlacebo comparatorA single IV bolus dose of normal saline solution.
Receives: Drug: Placebo
Subanesthetic IV Bolus KetamineExperimentala 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.

  1. Suicidality

    Beck Suicidal Ideation Scale (BSS)

    Measured: Baseline

Secondary outcomes (2)
  1. 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

  2. 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.

  1. First posted4 Mar 2015 (estimated)
  2. Study startDec 2011
  3. Primary completionJun 2013
  4. Study completionJun 2013

Why it stopped: Discrepancies in medication orders

Resources

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)
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

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.

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