Ketamine for Treatment-resistant Depression: A Multicentric Clinical Trial in Mexican Population
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Ketamine for Treatment-resistant Depression: A Multicentric Clinical Trial in Mexican Population|
- Changes in baseline HDRS Score [ Time Frame: 20 minutes before and 40 minutes after ketamine infusion. ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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. ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||September 2013|
|Estimated Primary Completion Date:||May 2016 (Final data collection date for primary outcome measure)|
|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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|
|Principal Investigator:||Rodrigo Perez-Esparza, M.D.||National Institute of Neurology and Neurosurgery, Mexico|
|Study Director:||David N Lopez-Garza, M.D.||American British Cowdray Medical Center|
|Study Director:||Jesus Ramirez-Bermudez, M.D.||National Institute of Neurology and Neurosurgery, Mexico|
|Principal Investigator:||Manuel Ruiz-Alvarez, M.D.||American British Cowdray Medical Center|