Ketamine's brain impact under the scanner: new study targets synaptic loss
NCT ID NCT02734602
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study uses PET and MRI scans to measure brain cell connections in people with major depression or PTSD. Researchers will give ketamine to see if it can reverse synaptic loss linked to these conditions. The goal is to understand brain changes, not to provide treatment. About 130 adults aged 18-70 will participate.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ketamine
- What this could lead to
- If successful, this could reveal how ketamine affects brain connections in depression and PTSD, pointing toward new treatment targets.
- What could go wrong
- This is an early imaging study, not a treatment trial. It may not show clear changes, and results may not apply to all patients.
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
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 130 people
The number the study aims to enrol. It can still change while the study runs.
- Start date
-
Apr 2016
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
-
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
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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: * General inclusion criteria: 1. Subjects will be 18-70 years old, 2. English speaking, 3. No other DSM-5 diagnosis present, besides required as below. Inclusion criteria for depressed subjects: 1. Meet DSM-5 diagnostic criteria for Major Depressive Disorder, and for a current depressive episode. 2. Treatment or non-treatment seeking who understand that this study is for research purposes only. Inclusion criteria for healthy controls: 1\. No current, or history of any DSM-5 diagnosis. Inclusion criteria for PTSD subjects: 1\. Current Post Traumatic Stress Disorder. Inclusion criteria for bipolar subjects: 1\. Meet DSM-5 diagnostic criteria for bipolar disorder. Inclusion criteria for subjects undergoing ketamine treatment 1. Meet DSM-5 diagnostic criteria for Major Depressive Disorder, and for a current depressive episode, as assessed by structured interview for DSM-5 diagnosis (SCID). 2. Undergoing ketamine treatment. Exclusion Criteria: 1. History of significant medical illness that would contraindicate study participation based on above criteria and PI/MD history review. 2. Lifetime history of neurologic abnormality including seizure disorder, cerebrovascular or neoplastic lesion, neurodegenerative disorder, or significant head trauma resulting in post-traumatic amnesia \>24 hours. 3. Full scale IQ lower than 70. 4. Contraindication to MRI scanning including claustrophobia and presence of a ferromagnetic object, including orthodontic braces. All participants will be screened for metal objects by the same methods used for routine clinical MRI scanning. 5. Pregnancy or breast-feeding. 6. Met DSM-5 criteria for mild substance use disorder (except nicotine and marijuana) within the past 6 months or met DSM-5 criteria for moderate to severe substance use disorder within the past year. 7. Claustrophobia. 8. Current psychosis, active suicidal or homicidal ideation. 9. Positive urine toxicology screen (except for marijuana). 10. Contraindications to PET (e.g., past or current diagnosis of cancer, poor venous access for placement of venous lines). 11. History of prior radiation exposure for research purposes within the past year such that participation in this study would place them over FDA limits for annual radiation exposure. 12. Previous or anticipated radiation exposure at work within one year of the proposed research PET scans that precludes study participation. 13. Blood pressure \>130/80 (for Aim 2, ketamine challenge); blood pressure \>140/90 (non-ketamine groups). 14. Arterial line exclusion: History of a bleeding disorder or currently taking anticoagulants (such as Coumadin, Heparin, Pradaxa, Xarelto). 15. Arterial line exclusion: Blood donation within eight weeks of the start of the study. 16. Current diagnosis of MDD or PTSD with psychotic features. 17. Hematocrit levels below 35 mg/dl, and/or hemoglobin levels below 10 mg/dl. 18. Weight under 110 lbs for subjects who will participate in portions of this study for which the blood draw is at or above a typical blood donation.
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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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PET Center
New Haven, Connecticut, 06519, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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