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CompletedPhase 2Results posted

Low Dose Intravenous Ketamine in Treatment Resistant Depression Patients

NCT02935595 · ketamine · The University of Texas Health Science Center, Houston

Closed to entry
Status
Not accepting participants
Phase 2
Phase
9
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

The primary goal of the project is to study the effect of Ketamine on cortical neurophysiological function in TRD patients. The proposal employs robust and non-invasive neurophysiological techniques TMS and EEG to investigate the cortical excitability and oscillatory activity in patients with treatment resistant depression.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Cortical Excitability in the Dorsolateral Prefrontal Cortex (DLPFC) as Assessed by Transcranial Magnetic Stimulation-evoked Activity Detected by Electroencephalography (TMS-EEG)

    Measured over Baseline

  • Cortical Excitability in DLPFC Using TMS-EEG

    Measured over 4 hours

  • Cortical Excitability in DLPFC Using TMS-EEG

    Measured over 24 hours

  • Cortical Excitability in DLPFC Using TMS-EEG

    Measured over 7 days

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 60 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * Be between 18-60 years of age * Meet criteria for Treatment Resistant Depression (defined as two or more unsuccessful trials of antidepressants at an adequate dose for at least 4 weeks) Exclusion Criteria: * Diagnosed with intellectual disability, eg. Mental retardation, neurodegenerative diseases, eg. Early onset neurocognitive disturbances such as frontotemporal dementia or behavioral disorders, eg. adult onset Attention Deficit Hyperactivity Disorder, * Diagnosed with Bipolar Disorder (BD), * Diagnosed with personality disorders, * Previously or currently diagnosed with psychosis (schizoaffective disorder -SAD) or schizophrenia - SCZ), * Current major medical problems that affect brain anatomy, neurochemistry, or function, e.g., obstructive sleep apnea requiring Continuous Positive Airway Pressure (CPAP), liver insufficiency, kidney insufficiency, cardiovascular problems, systemic infections, cancer, auto-immune diseases, and any brain disorder (seizure disorder, stroke, dementia, degenerative neurologic diseases); history of any brain diseases, including seizures, stroke, meningitis, encephalitis, dementia, degenerative brain diseases, and head injury with loss of consciousness for any period of time, * Diagnosed specifically with a cardiovascular disorders such as Hypertension, Arrhythmias, Chronic Heart Failure, Myocardial Infarction (MI) or suffering from Chronic Obstructive Pulmonary Disease (COPD) or asthma. Cardiac clearance prior to enrolling in the study and medical records from physician will be required per patient's Primary Care Physician. * Patients with increased risk of laryngospasm, active upper respiratory infections, respiratory depression, increased intracranial pressure, thyroid disease, or porphyria, * Current substance abuse or dependence. Only patients who achieved stable, full remission for at least 6 months will be included * Pregnancy or Breast feeding. All female in reproductive age will undergo pregnancy tests. Female participants will be required to provide evidence of use of contraceptives during the course of the study, * Unable to understand the design and requirements of the study. * Unable to sign the informed consent for any reason.

Where

1 study site

FacilityCityRegionCountry
Harris County Psychiatric CenterHoustonTexasUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT02935595 on ClinicalTrials.gov →

Last updated in the registry 2022-01-13. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits