Clinical Trial of the Use of Ketamine in Treatment Resistant Depression

National Institute of Neurology and Neurosurgery, Mexico

Status and phase: Unknown; Phase 4

Conditions: Depressive Disorder, Treatment-Resistant

Treatments: Drug: Ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT02610712

63/13

Details and patient eligibility

About

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.

Full 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).

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

TRD patients

Experimental group

Description:

Treatment-Resistant (TRD) patients to receive intravenous ketamine at 0.5 mg/kg dose.

Treatment:

Drug: Ketamine