Clinical Trial of the Use of Ketamine in Treatment Resistant Depression

Study Overview
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Brief Summary
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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
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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).

Official Title
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Clinical Trial of the Use of Ketamine in Treatment Resistant Depression

Conditions
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Depressive Disorder, Treatment-Resistant

Intervention / Treatment
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* Drug: Ketamine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Rating Scale (HDRS) Score |  | 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) | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ketamine, treatment-resistant, depression, spectroscopy, neuroinflammation