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Clinical Trial of the Use of Ketamine in Treatment Resistant Depression

Primary Purpose

Depressive Disorder, Treatment-Resistant

Status
Unknown status
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
Ketamine
Sponsored by
National Institute of Neurology and Neurosurgery, Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder, Treatment-Resistant focused on measuring ketamine, treatment-resistant, depression, spectroscopy, neuroinflammation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Institute of Neurology and NeurosurgeryRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TRD patients

Arm Description

Treatment-Resistant (TRD) patients to receive intravenous ketamine at 0.5 mg/kg dose.

Outcomes

Primary Outcome Measures

Hamilton Depression Rating Scale (HDRS) Score

Secondary Outcome Measures

Glutamate concentrations in the pregenual cingulate cortex (pgACC)
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
Interleukin-1 and Tumoral Necrosis Factor-alpha concentrations in serum measured by ELISA

Full Information

First Posted
November 17, 2015
Last Updated
September 20, 2016
Sponsor
National Institute of Neurology and Neurosurgery, Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT02610712
Brief Title
Clinical Trial of the Use of Ketamine in Treatment Resistant Depression
Official Title
Clinical Trial of the Use of Ketamine in Treatment Resistant Depression
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Institute of Neurology and Neurosurgery, Mexico

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Treatment-Resistant
Keywords
ketamine, treatment-resistant, depression, spectroscopy, neuroinflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TRD patients
Arm Type
Experimental
Arm Description
Treatment-Resistant (TRD) patients to receive intravenous ketamine at 0.5 mg/kg dose.
Intervention Type
Drug
Intervention Name(s)
Ketamine
Primary Outcome Measure Information:
Title
Hamilton Depression Rating Scale (HDRS) Score
Time Frame
Change from baseline HDRS Score at 24 hours
Secondary Outcome Measure Information:
Title
Glutamate concentrations in the pregenual cingulate cortex (pgACC)
Description
Glutamate concentrations in the pregenual cingulate cortex measured by Magnetic Resonance Spectroscopy
Time Frame
Change from baseline Glutamate concentrations in the pgACC at 24 hours
Title
Interleukin-1 (IL-1) and Tumoral Necrosis Factor-alpha (TNF-alpha) serum concentrations
Description
Interleukin-1 and Tumoral Necrosis Factor-alpha concentrations in serum measured by ELISA
Time Frame
Change from baseline IL-1 and TNF-alpha serum concentrations from baseline at 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rodrigo Pérez-Esparza, MD
Phone
56063822
Ext
1034
Email
dr.rodrigope@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jesús Ramírez-Bermúdez, MD, MSc
Phone
56063822
Ext
1034
Email
jesusramirezb@yahoo.com.mx
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodrigo Pérez-Esparza, MD
Organizational Affiliation
National Institute of Neurology and Neurosurgery, Mexico
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jesús Ramírez-Bermúdez, MD, MSc
Organizational Affiliation
National Institute of Neurology and Neurosurgery, Mexico
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institute of Neurology and Neurosurgery
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
14269
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rodrigo Pérez-Esparza, MD
Phone
56063822
Ext
1034
Email
dr.rodrigope@gmail.com
First Name & Middle Initial & Last Name & Degree
Jesús Ramírez-Bermúdez, MD, MSc
Phone
56063822
Ext
1034
Email
jesusramirezb@yahoo.com.mx

12. IPD Sharing Statement

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Clinical Trial of the Use of Ketamine in Treatment Resistant Depression

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