A Study to Decrease Suicidal Thinking Using Ketamine
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|ClinicalTrials.gov Identifier: NCT02418702|
Recruitment Status : Unknown
Verified August 2016 by United States Naval Medical Center, San Diego.
Recruitment status was: Not yet recruiting
First Posted : April 16, 2015
Last Update Posted : August 22, 2016
|Condition or disease||Intervention/treatment||Phase|
|Depression Suicide||Drug: 0.2 mg/kg ketamine Other: placebo||Phase 3|
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 Data collection was highly flawed, but unpublished, preliminary results show that the ketamine treatment resulted in significant decreased in suicidal thinking.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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized Controlled Trial to Decrease Suicidal Thinking Using Ketamine|
|Study Start Date :||December 2016|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||June 2018|
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.
Drug: 0.2 mg/kg ketamine
20 patients will randomly be assigned 0.2 mg/kg of Ketamine
Other Name: Ketamine
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
- 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 ]measure whether a significant reduction in depressive symptoms, as assessed by the BSS, BHS, and BDI occurs shortly after administration of ketamine
- 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 ]
- 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 ]
- Reduction in suicidal thinking measured by BSS, BHS, and BDI [ Time Frame: 1 day post-infusion ]single bolus of ketamine's effect on sustained reduction of symptoms
- Reduction in suicidal thinking measured by BSS, BHS, and BDI [ Time Frame: 2 weeks post-infusion ]
- Reduction in suicidal thinking measured by BSS, BHS, and BDI [ Time Frame: 10 weeks post-infusion ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02418702
|Contact: Maria E Vargasemail@example.com|
|United States, California|
|Naval Medical Center San Diego||Not yet recruiting|
|San Diego, California, United States, 92134|
|Contact: Maria E Vargas firstname.lastname@example.org|
|Principal Investigator:||Marc A Capobianco||United States Naval Medical Center, San Diego|