Pilot Study: Establishing Glutamatergic Changes... — Clinical Trial Details

This single-group, early-phase study will use GluCEST imaging at 7T to measure glutamatergic activity and inferred synaptic strength before and after a single intravenous ketamine infusion (0.5 mg/kg, 40 minutes) in people with treatment-resistant MDD.

Participants complete baseline clinical assessments (SCID, HAM-D, PANAS, VAS, POMS), a baseline MRI, the ketamine infusion with continuous vital monitoring, post-infusion mood assessments, a one-hour observation period, and a follow-up MRI later the same day to assess acute changes in glutamatergic signal.

Inclusion Criteria:
1. Age between 25 and 65 years;
2. Current depression as assessed on the SCID;
3. Treatment-resistant depression, defined by failure of at least two previous antidepressant or mood-stabilising treatments within the current depressive episode (adequate dose ≥8 weeks);
4. Able to comprehend English;
5. Ability to provide informed consent and pass a comprehension assessment related to ketamine and trial objectives.

Exclusion Criteria:
1. A sleep disorder other than insomnia;
2. History of bipolar disorder, delirium, dementia, amnestic disorder, schizophrenia or other psychotic disorders as assessed on the SCID;
3. Alcohol or drug abuse in the past year based on SCID or urine toxicology;
4. Current smoker;
5. Any significant medical or neurological illness that impacts brain function or impedes participation;
6. History of head trauma with significant loss of consciousness;
7. Metallic implants, pacemakers, tattoos, or other contraindications to MRI; claustrophobia or intolerance of scanner environment;
8. Pregnancy;
9. Untreated hypertension;
10. BMI over 40;
11. Ongoing prescription of ≥4 mg lorazepam equivalents daily, or morning dosing of any benzodiazepine at time of assessment;
12. Current or recent ECT, transcranial magnetic stimulation, vagal nerve stimulation, or deep brain stimulation as acute or maintenance treatment;
13. Use of any MAOI within two weeks prior to administration of study drug;
14. Use of CYP3A4 inducers (carbamazepine, modafinil) within two weeks prior to administration and within 24 hours after last dose of study drug;
15. Current use of naltrexone;
16. Developmental delay or intellectual disability;
17. Clinical or self-reported delirium, encephalopathy, or related diagnosis within the prior 12 months;
18. Prior participation in another study of ketamine for depression;
19. Prior treatment and/or recreational use of ketamine.

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Pilot Study: Establishing Glutamatergic Changes in Rapid Antidepressant Effects of Ketamine

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Study Arms & Interventions

Ketamine infusion

Interventions

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Inclusion Criteria

Exclusion Criteria

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