Clinical Trial of the Use of Ketamine in Treatment Resistant Depression
Overview
- Phase
- Phase 4
- Intervention
- Ketamine
- Conditions
- Depressive Disorder, Treatment-Resistant
- Sponsor
- National Institute of Neurology and Neurosurgery, Mexico
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Hamilton Depression Rating Scale (HDRS) Score
- Last Updated
- 9 years ago
Overview
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).
Investigators
Rodrigo Pérez Esparza
Fourth-year Psychiatry Resident
National Institute of Neurology and Neurosurgery, Mexico
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
- •Major neurological disease
- •Uncontrolled systemic arterial hypertension
- •MRI contraindications
Arms & Interventions
TRD patients
Treatment-Resistant (TRD) patients to receive intravenous ketamine at 0.5 mg/kg dose.
Intervention: Ketamine
Outcomes
Primary Outcomes
Hamilton Depression Rating Scale (HDRS) Score
Time Frame: Change from baseline HDRS Score at 24 hours
Secondary Outcomes
- Glutamate concentrations in the pregenual cingulate cortex (pgACC)(Change from baseline Glutamate concentrations in the pgACC at 24 hours)
- Interleukin-1 (IL-1) and Tumoral Necrosis Factor-alpha (TNF-alpha) serum concentrations(Change from baseline IL-1 and TNF-alpha serum concentrations from baseline at 24 hours)