Endogenous Opioid Modulation by Ketamine
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03051945|
Recruitment Status : Withdrawn (Unable to perform brain imaging)
First Posted : February 14, 2017
Last Update Posted : January 28, 2020
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Drug: Ketamine Hydrochloride Other: Normal saline||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Endogenous Opioid Modulation by Ketamine|
|Estimated Study Start Date :||August 2019|
|Actual Primary Completion Date :||August 1, 2019|
|Actual Study Completion Date :||August 1, 2019|
Ketamine will be infused via intravenous catheter over 40 minutes (0.75 mg/kg/hr over 40 minutes, 0.5 mg/kg total).
Drug: Ketamine Hydrochloride
Study drug will be infused while the participant sits or lies in a comfortable position. The dose of ketamine used does not cause unconsciousness but may cause perceptual disturbances.
Placebo Comparator: Placebo
Normal saline will be infused via intravenous catheter over 40 minutes (0.75 mg/kg/hr over 40 minutes, 0.5 mg/kg total).
Other: Normal saline
- Hamilton Depression Rating Scale at 24 hours, change from baseline [ Time Frame: 24 hr ]total score on the 17-item Hamilton Depression Rating 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): NCT03051945
|United States, Utah|
|Huntsman Cancer Institute|
|Salt Lake City, Utah, United States, 84112|