Depressive Disorder, Treatment-Resistant
Conditions
Keywords
ketamine, treatment-resistant, depression, spectroscopy, neuroinflammation
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).
Interventions
DRUGKetamine
Sponsors
National Institute of Neurology and Neurosurgery, Mexico
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Depression Rating Scale (HDRS) Score | Change from baseline HDRS Score at 24 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glutamate concentrations in the pregenual cingulate cortex (pgACC) | Change from baseline Glutamate concentrations in the pgACC at 24 hours | 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 | 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 |
Countries
Mexico
Contacts
Primary ContactRodrigo Pérez-Esparza, MD
Backup ContactJesús Ramírez-Bermúdez, MD, MSc
Outcome results
None listed