Clinical Trial: Clinical Trial of the Use of Ketamine in Treatment Resistant Depression
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Clinical Trial of the Use of Ketamine in Treatment Resistant Depression
Brief Summary: The purpose of this study is to determine the efficacy of the use of intravenous low-dose ketamine in the treatment of treatment-resistant depression (TRD), as well as the changes in Glutamate neurotransmission and inflammatory serum markers.
Detailed Summary: The purpose of this study is to determine the efficacy of the use of intravenous low-dose ketamine (0.5 mg/kg) in the treatment of treatment-resistant depression (TRD), as well as the changes in Glutamate neurotransmission measured by Magnetic Resonance Imaging Spectroscopy and inflammatory serum markers (IL-6, TNF-alpha).
Sponsor: National Institute of Neurology and Neurosurgery, Mexico
Current Primary Outcome: Hamilton Depression Rating Scale (HDRS) Score [ Time Frame: Change from baseline HDRS Score at 24 hours ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Glutamate concentrations in the pregenual cingulate cortex (pgACC) [ Time Frame: Change from baseline Glutamate concentrations in the pgACC at 24 hours ]Glutamate concentrations in the pregenual cingulate cortex measured by Magnetic Resonance Spectroscopy
- Interleukin-1 (IL-1) and Tumoral Necrosis Factor-alpha (TNF-alpha) serum concentrations [ Time Frame: Change from baseline IL-1 and TNF-alpha serum concentrations from baseline at 24 hours ]Interleukin-1 and Tumoral Necrosis Factor-alpha concentrations in serum measured by ELISA
Original Secondary Outcome: Same as current
Information By: National Institute of Neurology and Neurosurgery, Mexico
Dates:
Date Received: November 17, 2015
Date Started: May 2014
Date Completion:
Last Updated: September 20, 2016
Last Verified: September 2016
