A Study to Decrease Suicidal Thinking Using Ketamine
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Depression, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/2/2016 |
| Start Date: | May 2015 |
| End Date: | May 2016 |
| Contact: | Carol A Drastal, RN, MPH |
| Email: | carolanne.drastal.ctr@mail.mil |
| Phone: | 619-379-5625 |
A Randomized Controlled Trial to Decrease Suicidal Thinking Using Ketamine
Depression treatment typically is slow acting. Patients presenting with acute suicidality
have few immediate treatment options. However, sub-anesthetic doses of ketamine have been
now widely tested as a rapid-acting treatment for depression. Gregory Larkin et al at Yale
showed this could be applied to suicidal patients, with 14 of 15 participants showing
remission of suicidal thinking within 40 min of the administration of ketamine, with 13
showing lasting remission out to 10 days. No serious side effects were reported. This
project proposes to conduct a randomized, placebo-controlled trial of this, same
intervention in military patients recently hospitalized for suicidal thinking. After being
assessed, and giving informed consent, participants would receive 0.2mg/kg ketamine or
placebo. Their suicidal thinking, depression, and other symptoms would be monitored acutely
for 240 min after drug infusion, and the for lasting changes the next day, at hospital
discharge, 2 weeks, and 10 weeks. Potential adverse events will be monitored via the
electronic medical record for up to a year.
have few immediate treatment options. However, sub-anesthetic doses of ketamine have been
now widely tested as a rapid-acting treatment for depression. Gregory Larkin et al at Yale
showed this could be applied to suicidal patients, with 14 of 15 participants showing
remission of suicidal thinking within 40 min of the administration of ketamine, with 13
showing lasting remission out to 10 days. No serious side effects were reported. This
project proposes to conduct a randomized, placebo-controlled trial of this, same
intervention in military patients recently hospitalized for suicidal thinking. After being
assessed, and giving informed consent, participants would receive 0.2mg/kg ketamine or
placebo. Their suicidal thinking, depression, and other symptoms would be monitored acutely
for 240 min after drug infusion, and the for lasting changes the next day, at hospital
discharge, 2 weeks, and 10 weeks. Potential adverse events will be monitored via the
electronic medical record for up to a year.
Patients presenting for acute suicidality have few immediate treatment options to alleviate
their suffering aside from psychiatric hospitalization for safety assurance. Therapy and
psychiatry medication may decrease depression over time, but this does little to improve
depression and suicidal thinking in the short term. Preliminary data from a recent study by
Larkin et al at Yale University showed evidence to support a promising novel treatment
modality with rapid effects on suicidal ideation for up to 10 days post infusion through the
use of a single sub-anesthetic rapid intravenous bolus dose of ketamine (0.2-mg/kg)
administered in the acute Emergency Department setting. This study showed favorable evidence
to support further investigation into the use of a single sub-anesthetic bolus dose of
ketamine in acutely depressed and/or suicidal patients in the emergency room setting. Based
on the success of this study, Naval Medical Center San Diego (NMCSD) started the previously
mentioned, small, unfunded randomized, placebo-controlled trial of this ketamine protocol
for patients who were pending psychiatric hospitalization because of suicidal thinking. Data
collection was highly flawed, but unpublished, preliminary results show that the ketamine
treatment resulted in significant decreased in suicidal thinking.
Of note, there were no adverse events associated with the ketamine administration. Although
the infusion was done in an Emergency Department (ED) setting, the patients were seated in
clinic chairs, and required no additional monitoring or intervention beyond what could be
provided in any clinic our psychiatric hospital setting. It is the intent of the project to
expand on our unfunded trial, allowing us to treat a wider range of participants who come in
to the psychiatric ward because of suicidal thinking. This study is being pursued in the
context that existing therapies for major depression have a lag of onset of action of
several weeks, resulting in an increased risk of possible and considerable morbidity and
possibly mortality through suicide. This study would explore the efficacy of Ketamine's (a
N-Methyl-D-aspartate (NMDA) receptor antagonist) rapid and potentially long-lasting
antidepressant effects in a suicidal population. The Investigators hope to gather data that
could potentially impact treatment practices in the military setting for acutely depressed
patients. This may potentially shorten, delay, or even forgo admissions to the psychiatric
ward in the future, as well as potentially reducing the long term suicidality.
their suffering aside from psychiatric hospitalization for safety assurance. Therapy and
psychiatry medication may decrease depression over time, but this does little to improve
depression and suicidal thinking in the short term. Preliminary data from a recent study by
Larkin et al at Yale University showed evidence to support a promising novel treatment
modality with rapid effects on suicidal ideation for up to 10 days post infusion through the
use of a single sub-anesthetic rapid intravenous bolus dose of ketamine (0.2-mg/kg)
administered in the acute Emergency Department setting. This study showed favorable evidence
to support further investigation into the use of a single sub-anesthetic bolus dose of
ketamine in acutely depressed and/or suicidal patients in the emergency room setting. Based
on the success of this study, Naval Medical Center San Diego (NMCSD) started the previously
mentioned, small, unfunded randomized, placebo-controlled trial of this ketamine protocol
for patients who were pending psychiatric hospitalization because of suicidal thinking. Data
collection was highly flawed, but unpublished, preliminary results show that the ketamine
treatment resulted in significant decreased in suicidal thinking.
Of note, there were no adverse events associated with the ketamine administration. Although
the infusion was done in an Emergency Department (ED) setting, the patients were seated in
clinic chairs, and required no additional monitoring or intervention beyond what could be
provided in any clinic our psychiatric hospital setting. It is the intent of the project to
expand on our unfunded trial, allowing us to treat a wider range of participants who come in
to the psychiatric ward because of suicidal thinking. This study is being pursued in the
context that existing therapies for major depression have a lag of onset of action of
several weeks, resulting in an increased risk of possible and considerable morbidity and
possibly mortality through suicide. This study would explore the efficacy of Ketamine's (a
N-Methyl-D-aspartate (NMDA) receptor antagonist) rapid and potentially long-lasting
antidepressant effects in a suicidal population. The Investigators hope to gather data that
could potentially impact treatment practices in the military setting for acutely depressed
patients. This may potentially shorten, delay, or even forgo admissions to the psychiatric
ward in the future, as well as potentially reducing the long term suicidality.
Inclusion Criteria:
- Voluntarily, psychiatrically hospitalized at NMCSD within the last 12 hours for
suicidal thinking
- BSS greater than 4
- BHS greater than 8
- BDI greater than 19
- Ability to give informed consent
- Active duty military status
- Verified negative pregnancy test for females
Exclusion Criteria:
- Psychosis or bipolar disorder
- Pregnancy
- Involuntary status on presentation to the ED
- Positive for illicit drugs of abuse
- Blood alcohol level greater than zero
- Previous enrollees in this treatment protocol will be excluded from repeat
participation
- Any patient brought for command directed psychiatric evaluation
- Specific contraindication 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:
A) patients with elevated intracranial pressure, uncontrolled hypertension, coronary
artery disease, aneurysms, thyrotoxicosis, congestive heart failure (CHF), a recent
history of head or eye injury, or angina B) all personnel in whom a significant elevation
of blood pressure would constitute a serious hazard to their overall health and well-being
C) patients currently utilizing the following medications: conivaptan, dasatinib,
peginterferon alfa-2b, quazepam, tocilizumab
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Naval Medical Center - San Diego We are the largest and most comprehensive military healthcare...
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