A Phase 2 interventional study of Ketamine and Placebo in Depressive Disorder, and Treatment-Resistant Depression, sponsored by Paul J. Lamothe. Status unknown at 1 site in Mexico. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-03-17.
Sponsored by Paul J. Lamothe · Phase 2, Interventional, and Treatment
A randomized multicentric parallel arms study involving the use of ketamine for treatment-resistant depression will be held at three national health provider clinics in the Mexican population. The purpose of this study is to determine whether clinical response seen in previous studies is replicable in this population.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's planned enrollment of 60 is below the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →This is the only study on the registry with Paul J. Lamothe as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Ketamine
Drug: Placebo
A single dose of 0.5mg/kg intravenous ketamine infusion will be administered over 40 minutes.
Also known as: Ketalar
Saline at 0.9% intravenous infusion will be administered over 40 minutes.
Changes in baseline HDRS Score
The Hamilton Depression Rating Scale (HDRS) baseline score will be measured 20 minutes before ketamine infusion. After 40 minutes post-infusion, a second HDRS score will be obtained.
Time frame: 20 minutes before and 40 minutes after ketamine infusion.
Daily change in HDRS post-ketamine infusion.
On a daily basis, from day 1-7 post-ketamine infusion, changes in HDRS score will be measured during the daily psychiatric evaluation.
Time frame: 1,2,3,4,5,6 and 7. Days after ketamine infusion
Baseline blood pressure (BP).
Baseline BP will be measured during the physical examination 20 minutes before ketamine infusion.
Time frame: 20 minutes before ketamine infusion.
Changes from baseline in blood pressure (BP)
BP will be monitored continuously for a 4-hour period. BP assessments will be taken every five minutes for the period mentioned. The assessment will start 20 minutes before ketamine administration and will finish 4hrs after starting.
Time frame: every 5 minutes in a 300 minutes period
This study is status unknown, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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