Ketamine for Treatment-resistant Depression: A Multicentric Clinical Trial in Mexican Population
|ClinicalTrials.gov Identifier: NCT01868802|
Recruitment Status : Unknown
Verified March 2015 by Paul J. Lamothe, American British Cowdray Medical Center.
Recruitment status was: Recruiting
First Posted : June 5, 2013
Last Update Posted : March 17, 2015
|Condition or disease||Intervention/treatment||Phase|
|Depressive Disorder, Treatment-Resistant Depression||Drug: Ketamine Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Ketamine for Treatment-resistant Depression: A Multicentric Clinical Trial in Mexican Population|
|Study Start Date :||September 2013|
|Estimated Primary Completion Date :||May 2016|
|Experimental: Ketamine treated||
A single dose of 0.5mg/kg intravenous ketamine infusion will be administered over 40 minutes.
Other Name: Ketalar
|Placebo Comparator: Control, placebo treated||
Saline at 0.9% intravenous infusion will be administered over 40 minutes.
- Changes in baseline HDRS Score [ Time Frame: 20 minutes before and 40 minutes after ketamine infusion. ]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.
- Daily change in HDRS post-ketamine infusion. [ Time Frame: 1,2,3,4,5,6 and 7. Days after 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.
- Baseline blood pressure (BP). [ Time Frame: 20 minutes before ketamine infusion. ]Baseline BP will be measured during the physical examination 20 minutes before ketamine infusion.
- Changes from baseline in blood pressure (BP) [ Time Frame: every 5 minutes in a 300 minutes period ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01868802
|Contact: Paul J Lamothe, M.D.||+52 (55) email@example.com|
|Contact: David N Lopez-Garza, M.D.||+ 52 (55) firstname.lastname@example.org|
|ABC Neurological Center||Recruiting|
|Mexico City, DF, Mexico, 05300|
|Contact: Eduardo San Esteban, M.D. +52 (55) 52308000 email@example.com|
|Principal Investigator: Paul J Lamothe Molina, M.D.|
|Principal Investigator:||Paul J Lamothe, M.D.||American British Cowdray Medical Center|
|Study Director:||David N Lopez-Garza, M.D.||American British Cowdray Medical Center|
|Principal Investigator:||Manuel Ruiz-Alvarez, M.D.||American British Cowdray Medical Center|