Clinical Trial of the Use of Ketamine in Treatment Resistant Depression

September 20, 2016 updated by: Rodrigo Pérez Esparza, National Institute of Neurology and Neurosurgery, Mexico
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Mexico
    • Distrito Federal
      • Mexico City, Distrito Federal, Mexico, 14269
        • Recruiting
        • National Institute of Neurology and Neurosurgery
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hamilton Depression Rating Scale (HDRS) Score
Time Frame: Change from baseline HDRS Score at 24 hours
Change from baseline HDRS Score at 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from baseline Glutamate concentrations in the pgACC at 24 hours
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
Change from baseline IL-1 and TNF-alpha serum concentrations from baseline at 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

November 17, 2015

First Submitted That Met QC Criteria

November 19, 2015

First Posted (Estimate)

November 20, 2015

Study Record Updates

Last Update Posted (Estimate)

September 21, 2016

Last Update Submitted That Met QC Criteria

September 20, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 63/13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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