Depression brain study withdrawn before it began
NCT ID NCT05991232
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study aimed to track brain activity in people with depression over time and see how a single dose of ketamine might change it. It was withdrawn before any participants were enrolled, so no results are available.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Intravenous ketamine
- What this could lead to
- If successful, this could help identify brain targets for depression treatment and show how ketamine affects them.
- What could go wrong
- The study was withdrawn before enrolling anyone, so no data was collected. It was also small and early-stage, so results would have been preliminary.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Started
-
May 2025
- Expected to finish
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Apr 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 60 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: All participants will: 1. be between the ages of 18 and 60 years, 2. score ≥ 14 on the Hamilton Depression Rating Scale (Ham-D) 3. possess a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign an informed consent document Exclusion Criteria: All participants: 1. Presence of lifetime bipolar, psychotic, or autism spectrum; current problematic substance use (e.g., ongoing moderate-to-severe substance use disorder); 2. Failure to meet standard MRI inclusion criteria: those who have cardiac pacemakers, neural pacemakers, cochlear implants, metal braces, or other non-MRI-compatible metal objects in their body. History of significant injury or surgery to the brain or spinal cord that would impair interpretation of results. 3. Acute suicidality or other psychiatric crises requiring treatment escalation. We will use the Columbia Suicide Severity Rating Scale (CSSRS) as both an initial exclusion criteria (CSSRS "Baseline/Screening" Version for past 1month period) and as grounds for rescue/removal (CSSRS "Since Last Visit" form). The CSSRS will be administered using a paper form by an experienced and thoroughly trained clinical assessor on the study team. Subjects with CSSRS suicide ideation scores scored "yes" on items 4 (active suicidal ideation with some intent to act) and/or 5 (active suicidal ideation with specific plan and intent) will be excluded from the study, and if enrolled, will be exited from the study and referred immediately to the nearest emergency mental health facility for additional thorough assessment and appropriate treatment referral. 4. Changes made to treatment regimen within 4 weeks of baseline assessment. 5. Reading level \<6th grade as per patient self-report. 6. Patients who have received ECT in the past 2 months prior to Screening. Ketamine phase subsample additional exclusion criteria: 1. Patients currently taking any psychotropic medication. 2. Lifetime recreational ketamine or PCP use 3. Current pregnancy or breastfeeding 4. For ketamine phase entry, patients must be reasonable medical candidates for ketamine infusion, as determined by a physician co-investigator. Serious, unstable medical illnesses including respiratory \[obstructive sleep apnea, or history of difficulty with airway management during previous anesthetics\], cardiovascular \[including ischemic heart disease and uncontrolled hypertension\], and neurologic \[including history of severe head injury\] will be exclusions. 5. Clinically significant abnormal findings of laboratory parameters \[including urine toxicology screen for drugs of abuse\], physical examination, or ECG. 6. Uncontrolled or poorly controlled hypertension, as determined by a physician co-investigator's review of vitals collected during screening and any other relevant medical history/records. 7. Patients with one or more seizures without a clear and resolved etiology. 8. Patients starting hormonal treatment (e.g., estrogen) in the 3 months prior to Screening. 9. Past intolerance or hypersensitivity to ketamine. 10. Patients taking medications with known activity at the NMDA or AMPA glutamate receptor \[e.g., riluzole, amantadine, memantine, topiramate, dextromethorphan, Dcycloserine\], or the mu-opioid receptor. 11. Patients taking any of the following medications: St John's Wort, theophylline, tramadol, metrizamide.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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The Ohio State University, Department of Psychiatry & Behavioral Health
Columbus, Ohio, 43210, United States
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