- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02418702
A Study to Decrease Suicidal Thinking Using Ketamine
A Randomized Controlled Trial to Decrease Suicidal Thinking Using Ketamine
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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 Data collection was highly flawed, but unpublished, preliminary results show that the ketamine treatment resulted in significant decreased in suicidal thinking.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.
Study Type
Phase
- Phase 3
Contacts and Locations
Study Locations
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California
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San Diego, California, United States, 92134
- Naval Medical Center San Diego
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 0.2mg/kg ketamine
After being assessed, and giving informed consent, participants would receive 0.2mg/kg ketamine.
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.
|
20 patients will randomly be assigned 0.2 mg/kg of Ketamine
Other Names:
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Placebo Comparator: placebo
After being assessed, and giving informed consent, participants would receive a placebo.
Symptoms will be monitored.
|
20 patients will randomly be assigned a placebo
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in baseline in depressive symptoms measured by Beck Scale for Suicide ideation (BSS), Beck Hopelessness Scale (BHS), and Beck Depression Index (BDI)
Time Frame: baseline and 240 minutes
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measure whether a significant reduction in depressive symptoms, as assessed by the BSS, BHS, and BDI occurs shortly after administration of ketamine
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baseline and 240 minutes
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Change in baseline in depressive symptoms measured by Beck Scale for Suicide ideation (BSS), Beck Hopelessness Scale (BHS), and Beck Depression Index (BDI)
Time Frame: baseline and 2 weeks
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baseline and 2 weeks
|
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Change in baseline in depressive symptoms measured by Beck Scale for Suicide ideation (BSS), Beck Hopelessness Scale (BHS), and Beck Depression Index (BDI)
Time Frame: baseline and 10 weeks
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baseline and 10 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction in suicidal thinking measured by BSS, BHS, and BDI
Time Frame: 1 day post-infusion
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single bolus of ketamine's effect on sustained reduction of symptoms
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1 day post-infusion
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Reduction in suicidal thinking measured by BSS, BHS, and BDI
Time Frame: 2 weeks post-infusion
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2 weeks post-infusion
|
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Reduction in suicidal thinking measured by BSS, BHS, and BDI
Time Frame: 10 weeks post-infusion
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10 weeks post-infusion
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Collaborators and Investigators
Investigators
- Principal Investigator: Marc A Capobianco, United States Naval Medical Center, San Diego
Publications and helpful links
General Publications
- Panzer O, Moitra V, Sladen RN. Pharmacology of sedative-analgesic agents: dexmedetomidine, remifentanil, ketamine, volatile anesthetics, and the role of peripheral mu antagonists. Crit Care Clin. 2009 Jul;25(3):451-69, vii. doi: 10.1016/j.ccc.2009.04.004.
- Zarate CA Jr, Singh JB, Carlson PJ, Brutsche NE, Ameli R, Luckenbaugh DA, Charney DS, Manji HK. A randomized trial of an N-methyl-D-aspartate antagonist in treatment-resistant major depression. Arch Gen Psychiatry. 2006 Aug;63(8):856-64. doi: 10.1001/archpsyc.63.8.856.
- Berman RM, Cappiello A, Anand A, Oren DA, Heninger GR, Charney DS, Krystal JH. Antidepressant effects of ketamine in depressed patients. Biol Psychiatry. 2000 Feb 15;47(4):351-4. doi: 10.1016/s0006-3223(99)00230-9.
- Sanacora G, Gueorguieva R, Epperson CN, Wu YT, Appel M, Rothman DL, Krystal JH, Mason GF. Subtype-specific alterations of gamma-aminobutyric acid and glutamate in patients with major depression. Arch Gen Psychiatry. 2004 Jul;61(7):705-13. doi: 10.1001/archpsyc.61.7.705.
- Melville NA. Bolus dose of ketamine offers fast-acting alleviation of acute depression in ED setting. Medscape Medical News. September 29, 2010.
- Messer MM, Haller IV. Maintenance ketamine treatment produces long-term recovery from depression. Primary Psychiatry. 2010; 17(4):48-50.
- Yilmaz A, Schulz D, Aksoy A, Canbeyli R. Prolonged effect of an anesthetic dose of ketamine on behavioral despair. Pharmacol Biochem Behav. 2002 Jan-Feb;71(1-2):341-4. doi: 10.1016/s0091-3057(01)00693-1.
- Zarate CA Jr, Du J, Quiroz J, Gray NA, Denicoff KD, Singh J, Charney DS, Manji HK. Regulation of cellular plasticity cascades in the pathophysiology and treatment of mood disorders: role of the glutamatergic system. Ann N Y Acad Sci. 2003 Nov;1003:273-91. doi: 10.1196/annals.1300.017.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Self-Injurious Behavior
- Depression
- Suicide
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Dissociative
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Ketamine
Other Study ID Numbers
- NMCSD.2014.0031
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