Glutamatergic Adaptation to Stress as a Mechanism for Anhedonia and Treatment Response With Ketamine

• Status: Not yet recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Emory University
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Ketamine

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, or Bipolar, depressed type 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 (non-mood-related) 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)

• 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

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 test

• contraindications for MRI

• MMSE score <28