Clinical trial NCT02610712: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Depressive Disorder, Treatment-Resistant
Keywords: ketamine
treatment-resistant
depression
spectroscopy
neuroinflammation
Lead sponsor: National Institute of Neurology and Neurosurgery, Mexico
Sponsor class: OTHER
First posted: 2015-11-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Hamilton Depression Rating Scale (HDRS) Score
timeFrame: Change from baseline HDRS Score at 24 hours
Secondary outcomes:
measure: Glutamate concentrations in the pregenual cingulate cortex (pgACC)
timeFrame: Change from baseline Glutamate concentrations in the pgACC at 24 hours
measure: Interleukin-1 (IL-1) and Tumoral Necrosis Factor-alpha (TNF-alpha) serum concentrations
timeFrame: Change from baseline IL-1 and TNF-alpha serum concentrations from baseline at 24 hours
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: National Institute of Neurology and Neurosurgery
state: Distrito Federal
Study officials:
affiliation: National Institute of Neurology and Neurosurgery, Mexico
name: Rodrigo Pérez-Esparza, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institute of Neurology and Neurosurgery, Mexico
name: Jesús Ramírez-Bermúdez, MD, MSc
role: PRINCIPAL_INVESTIGATOR
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