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Clinical Trial of the Use of Ketamine in Treatment Resistant Depression

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ClinicalTrials.gov Identifier: NCT02610712
Recruitment Status : Unknown
Verified September 2016 by Rodrigo Pérez Esparza, National Institute of Neurology and Neurosurgery, Mexico.
Recruitment status was:  Recruiting
First Posted : November 20, 2015
Last Update Posted : September 21, 2016
Sponsor:
Information provided by (Responsible Party):
Rodrigo Pérez Esparza, National Institute of Neurology and Neurosurgery, Mexico

Tracking Information
First Submitted Date  ICMJE November 17, 2015
First Posted Date  ICMJE November 20, 2015
Last Update Posted Date September 21, 2016
Study Start Date  ICMJE May 2014
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2015)
Hamilton Depression Rating Scale (HDRS) Score [ Time Frame: Change from baseline HDRS Score at 24 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02610712 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2015)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial of the Use of Ketamine in Treatment Resistant Depression
Official Title  ICMJE 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 Description 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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Depressive Disorder, Treatment-Resistant
Intervention  ICMJE Drug: Ketamine
Study Arms  ICMJE Experimental: TRD patients
Treatment-Resistant (TRD) patients to receive intravenous ketamine at 0.5 mg/kg dose.
Intervention: Drug: Ketamine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 19, 2015)
20
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Treatment-Resistant Depression (Failure to respond to two or more trials of antidepressant monotherapy or failure to respond to four or more trials of different antidepressant therapies)
  • Acceptance of participation via the informed consent

Exclusion Criteria:

  • Psychiatric comorbidity (except anxiety related disorders)
  • Substance abuse or dependence in the previous 3 months
  • Evidence of structural abnormalities in brain imaging
  • Pregnancy
  • Previous hypersensitivity to ketamine
  • Heart failure or insufficiency
  • Familial or personal history of psychosis
  • Glaucoma
  • Major neurological disease
  • Uncontrolled systemic arterial hypertension
  • MRI contraindications
  • Non-acceptance of participation via informed consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02610712
Other Study ID Numbers  ICMJE 63/13
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rodrigo Pérez Esparza, National Institute of Neurology and Neurosurgery, Mexico
Study Sponsor  ICMJE National Institute of Neurology and Neurosurgery, Mexico
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rodrigo Pérez-Esparza, MD National Institute of Neurology and Neurosurgery, Mexico
Principal Investigator: Jesús Ramírez-Bermúdez, MD, MSc National Institute of Neurology and Neurosurgery, Mexico
PRS Account National Institute of Neurology and Neurosurgery, Mexico
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP