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Trial record 12 of 201 for:    Depressive Disorder | "Depressive Disorder, Treatment-Resistant"

Clinical Trial of the Use of Ketamine in Treatment Resistant Depression

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ClinicalTrials.gov Identifier: NCT02610712
Recruitment Status : 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

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.

Condition or disease Intervention/treatment Phase
Depressive Disorder, Treatment-Resistant Drug: Ketamine Phase 4

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Trial of the Use of Ketamine in Treatment Resistant Depression
Study Start Date : May 2014
Estimated Primary Completion Date : December 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: TRD patients
Treatment-Resistant (TRD) patients to receive intravenous ketamine at 0.5 mg/kg dose.
Drug: Ketamine



Primary Outcome Measures :
  1. Hamilton Depression Rating Scale (HDRS) Score [ Time Frame: Change from baseline HDRS Score at 24 hours ]

Secondary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02610712


Contacts
Contact: Rodrigo Pérez-Esparza, MD 56063822 ext 1034 dr.rodrigope@gmail.com
Contact: Jesús Ramírez-Bermúdez, MD, MSc 56063822 ext 1034 jesusramirezb@yahoo.com.mx

Locations
Mexico
National Institute of Neurology and Neurosurgery Recruiting
Mexico City, Distrito Federal, Mexico, 14269
Contact: Rodrigo Pérez-Esparza, MD    56063822 ext 1034    dr.rodrigope@gmail.com   
Contact: Jesús Ramírez-Bermúdez, MD, MSc    56063822 ext 1034    jesusramirezb@yahoo.com.mx   
Sponsors and Collaborators
National Institute of Neurology and Neurosurgery, Mexico
Investigators
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

Publications:

Responsible Party: Rodrigo Pérez Esparza, Fourth-year Psychiatry Resident, National Institute of Neurology and Neurosurgery, Mexico
ClinicalTrials.gov Identifier: NCT02610712     History of Changes
Other Study ID Numbers: 63/13
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: September 21, 2016
Last Verified: September 2016

Keywords provided by Rodrigo Pérez Esparza, National Institute of Neurology and Neurosurgery, Mexico:
ketamine
treatment-resistant
depression
spectroscopy
neuroinflammation

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Mood Disorders
Mental Disorders
Behavioral Symptoms
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action