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WithdrawnPhase 1

Intravenous Ketamine Effects on Functional Neuroanatomy

NCT04205890 · Neurological Associates of West Los Angeles

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

What it is testing

Summary

The purpose of this study is to investigate the neuroanatomical effects of ketamine treatment on patients with treatment-resistant depression. The investigators will compare the neuroimaging of patients several days before and after injection in order to assess the more durable changes induced by ketamine. In addition, changes in perfusion will be analyzed, in addition to changes in neurovascular coupling, and functional connectivity that are correlated with psychiatric measures.

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

  • fMRI T1 baseline

    Measured over Images to be acquired 7 days prior to Ketamine intervention

  • fMRI T1 post-intervention comparison

    Measured over Images to be acquired at 2 days post-treatment

  • Arterial Spin Labeling (fMRI) baseline

    Measured over Images to be acquired 7 days prior to Ketamine intervention

  • Arterial Spin Labeling (fMRI) post-intervention comparison

    Measured over Images to be acquired at 2 days post-treatment

  • fMRI Resting Bold baseline

    Measured over Images to be acquired 7 days prior to Ketamine intervention

  • fMRI Resting Bold post-intervention comparison

    Measured over Images to be acquired at 2 days post-treatment

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 70 Years
Ages
All
Sex
Accepted
Healthy volunteers
Inclusion Criteria: * In order for a subject to be considered for this study, the patient must have been diagnosed with treatment-resistant depression, meaning the patient failed three medications and has been suffering from moderate treatment-resistant depression for over 6 months, indicated by a Beck Depression Inventory score of 10 or above. The patient must have been prescribed ketamine as part of their treatment plan, completely independent of any research. The patient must be willing to comply with the study protocol. Exclusion Criteria: * In order for a subject to be considered for this study, he/she may not have any of the following: * Advanced stages of any terminal illness or any active cancer that requires chemotherapy * Hepatic impairment * Significant cytopenia * Cardiovascular, cerebrovascular, and peripheral vascular arterial thrombosis * Women who are pregnant, may become pregnant, or are breastfeeding * Any counter indications to ketamine * Subjects unable to give informed consent or in vulnerable categories, such as prisoners

Where

1 study site

FacilityCityRegionCountry
Neurological Associates of West Los AngelesSanta MonicaCaliforniaUnited 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.

NCT04205890 on ClinicalTrials.gov →

Last updated in the registry 2020-06-01. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

Indication

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