Subanesthetic IV Bolus Ketamine in the Treatment of Acute Depression
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|ClinicalTrials.gov Identifier: NCT02378415|
Recruitment Status : Terminated (Discrepancies in medication orders)
First Posted : March 4, 2015
Last Update Posted : March 4, 2015
|Condition or disease||Intervention/treatment||Phase|
|Acute Depression||Drug: Ketamine Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Subanesthetic IV Bolus Ketamine in the Treatment of Acute Depression|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
Placebo Comparator: Normal Saline Infusion
A single IV bolus dose of normal saline solution.
Normal Saline Infusion
Experimental: Subanesthetic IV Bolus Ketamine
a single sub-anesthetic rapid IV bolus dose of ketamine administered to acutely depressed patients with or without suicidality
IV Bolus dose of ketamine dosed at 0.2mg/kg infused over 1-2 minutes.
Other Name: Ketalor.
- Suicidality [ Time Frame: Baseline ]Beck Suicidal Ideation Scale (BSS)
- Depression [ Time Frame: Baseline, 40-minutes, 80-minutes, 120-minutes, 240-minutes, exit at discharge, and at follow-up within 2-weeks ]Beck Depression Index (BDI)
- Hopelessness [ Time Frame: Baseline, 40-minutes, 80-minutes, 120-minutes, 240-minutes, exit at discharge, and at follow-up within 2-weeks ]Beck Hopelessness Scale
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): NCT02378415
|United States, California|
|Naval Medical Center San Diego|
|San Diego, California, United States, 92134|
|Principal Investigator:||Robert E Lovern, MD||United States Naval Medical Center, San Diego|