Clinical Trial of the Use of Ketamine in Treatment Resistant Depression

Phase 4

• Conditions: Depressive Disorder, Treatment-Resistant
• Interventions: Drug: Ketamine

• Registration Number: NCT02610712
• Lead Sponsor: National Institute of Neurology and Neurosurgery, Mexico

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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2015-11-17
• Study First Submitted QC: 2015-11-19
• Study First Posted: 2015-11-20
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-20
• Last Update Posted: 2016-09-21
• Primary Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Hamilton Depression Rating Scale (HDRS) Score	Change from baseline HDRS Score at 24 hours

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

National Institute of Neurology and Neurosurgery; 🇲🇽 Mexico City, Distrito Federal, Mexico