NCT05327699 Glutamatergic Adaptation to Stress as a Mechanism for Anhedonia and Treatment Response With Ketamine
| NCT ID | NCT05327699 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Emory University |
| Condition | Major Depressive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2022-11-08 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 140 participants in total. It began in 2022-11-08 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The main purpose of this study is to investigate the effects of ketamine on decision-making and emotion processing in a sample of individuals diagnosed with Major Depressive Disorder (MDD).
Eligibility Criteria
Inclusion Criteria: MDD Patients: * willing and able to give written informed consent * men or women, 18-65 years of age * primary diagnosis of DSM-V MDD, current, as diagnosed by the SCID-I * score of ≥20 on the Beck Depression Inventory, which will include patients characterized as having "moderate/severe" (20-28) or "very-severe" (29-63) depressive symptoms * off all antidepressant therapy for at least 8 weeks prior to the baseline visit Healthy Controls: * willing and able to give written informed consent * men or women, 18-65 years of age Exclusion Criteria: MDD Patients: * history of any bipolar disorder or psychotic disorder * active psychotic symptoms of any type * substance abuse/dependence within 6 months of study entry (as determined by SCID) * unstable cardiovascular, endocrinologic, hematologic, hepatic, renal, or neurologic disease (as determined by physical examination and laboratory testing), including upper respiratory disease or asthma, glaucoma or porphyria. * active suicidal ideation as determined by a score ≥3 on the Columbia Suicide Severity Rating Scale (C-SSR) * use of any recreational drugs as confirmed by urine drug screen at the time of scanning * pregnancy or lactation * use of glucocorticoids at any time during the study * Raynaud's disease that may interfere with the cold-pressor * contraindications for MRI * MMSE score \<28 * elevated blood pressure prior to infusion (systolic \> 160 or diastolic \>100) * history of treatment resistance as determined by ATRQ * prior adverse reaction to ketamine * use of antipsychotic medications * use of greater than 2mg daily of lorazepam or similar benzodiazipine. * Regular smoker as self-reported Healthy Controls: * evidence of any psychiatric disorder with exception of specific phobia, and no history of any psychiatric disorder except mild past substance use disorder as diagnosed by the SCID-I * history of any substance abuse within the last 6 months * use of any recreational drugs as confirmed by urine drug screen at the time of scanning * pregnancy or lactation * use of glucocorticoids at any time during the study * Raynaud's disease that may interfere with the cold-pressor * contraindications for MRI * MMSE score \<28 * Regular smoker as self-reported
Contact & Investigator
Michael Treadway, PhD
PRINCIPAL INVESTIGATOR
Emory University
Frequently Asked Questions
Who can join the NCT05327699 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Major Depressive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05327699 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05327699 currently recruiting?
Yes, NCT05327699 is actively recruiting participants. Contact the research team at ketaminestudy@emory.edu for enrollment information.
Where is the NCT05327699 trial being conducted?
This trial is being conducted at Atlanta, United States.
Who is sponsoring the NCT05327699 clinical trial?
NCT05327699 is sponsored by Emory University. The principal investigator is Michael Treadway, PhD at Emory University. The trial plans to enroll 140 participants.