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CompletedPhase 4Results posted

Ketamine for Depression: An MRI Study

NCT02544607 · Massachusetts General Hospital

Closed to entry
Status
Not accepting participants
Phase 4
Phase
25
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

Ketamine has been shown to decrease symptoms of anxious depression quickly. This decrease has been shown to last for up to one month. MRI technology will be used before and after ketamine for patients with depression to examine the extent to which certain brain areas predict ketamine's antidepressant effects.

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

  • Change in Hamilton Depression Rating Scale (HDRS) From Baseline/Minute 0 to 4 Hours Post-infusion.

    Measured over 4 hours

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 64 Years
Ages
All
Sex
Accepted
Healthy volunteers
Inclusion Criteria: Patients with Depression Patients will: 1. be 18-64 years old, 2. read, understand, and provide written informed consent in English, 3. meet criteria for a primary psychiatric diagnosis of major depressive disorder for ≥ 4 weeks, 4. have a history of ≥1 failed medication trial during the current depression 5. be on a stable antidepressant and psychotherapy regimen for ≥28 days, 6. maintain a treating doctor who is in agreement with study participation, 7. have a reliable chaperone accompany them home following the completion of the ketamine infusion day, 8. be generally healthy, as assessed by medical history, physical examination (including vital signs), clinical laboratory evaluations, and electrocardiogram (EKG), 9. be of non-childbearing potential or use of an acceptable form of birth control (females only), 10. be right handed. Exclusion Criteria: Patients with Depression Patients will be excluded if any of the following criteria are met: 1\) delirium or dementia diagnosis, 2) unstable medical illness or clinically significant laboratory results, 3) history of clinically significant cardiovascular disease or electrocardiogram (EKG) findings, or medical conditions that put the patient at risk for possible cardiac side effects or alter brain morphology (e.g., traumatic brain injury), 4) history of multiple adverse drug reactions, 5) current/past history of psychotic disorders, 6) active substance use disorders (except nicotine and caffeine) within the past six months or past history of ketamine/PCP abuse, 7) requirement of excluded medications that may interact with ketamine, 8) weigh \>250 lbs., 9) pregnancy, breastfeeding, or unacceptable means of birth control (females only) 10) presence of MRI contraindications (e.g., presence of metallic (ferromagnetic) implants (e.g., heart pacemaker, aneurysm clips)), 11) current serious suicidal or homicidal risk, or 12) concurrent participation in other research studies. \--------------------------------------------------------------------------------------- Inclusion Criteria: Healthy Controls Healthy Controls will: 1. be 18-64 years old, 2. read, understand, and provide written informed consent in English, 3. have a reliable chaperone accompany them home following the completion of the ketamine infusion day, 4. be generally healthy, as assessed by medical history, physical examination (including vital signs), clinical laboratory evaluations, and electrocardiogram (EKG), 5. be of non-childbearing potential or use of an acceptable form of birth control (females only), and 6. be right handed. Exclusion Criteria: Healthy Controls Healthy controls will be excluded if any of the following criteria are met: 1. current or past psychiatric diagnosis (excluding phobias), including alcohol or substance abuse or dependence diagnosis (except for nicotine or caffeine), 2. presence of MRI contraindications (e.g., presence of metallic (ferromagnetic) implants (e.g., heart pacemaker, aneurysm clips)), 3. presence of medical illness likely to alter brain morphology and/or physiology (e.g., traumatic brain injury), 4. requirement of excluded medications that may interact with ketamine, 5. presence of psychiatric disorders in first-degree relatives, 6. pregnancy, breastfeeding, or unacceptable means of birth control (females only), or 7. weight \>250 lbs.

Where

1 study site

FacilityCityRegionCountry
Massachusetts General HospitalBostonMassachusettsUnited 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.

NCT02544607 on ClinicalTrials.gov →

Last updated in the registry 2019-04-16. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits