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Recruiting NCT05327699

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

Early Phase I Interventional Major Depressive Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ketamine, Placebo.
Who it may be relevant to
Registry conditions: Major Depressive Disorder. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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).

Detailed description

The main purpose of this study is to understand the effects of sub-anesthetic ketamine doses on varying functional domains of depression such as anhedonia, decision-making, and emotion processing in subjects diagnosed with Major Depressive Disorder (MDD). The study will evaluate these effects using a combination of questionnaires, neuroimaging techniques, and behavioral tasks. The clinical trial portion will only include subjects with MDD (Major Depressive Disorder). A separate group of healthy controls, n=60, will be invited to only complete a behavioral/interview session and one neuroimaging session.The healthy controls group will not be randomized nor receive any study intervention and will only serve to collect performance baseline measures. The primary aims of this study are to evaluate 1) the glutamate stress response in MDD patients and matched controls by whole-brain imaging, 2) the multi-modal associations between glutamate stress response and neuroimaging and behavioral assessments of motivation and valuation, and 3) the effect of ketamine versus placebo on glutamate stress response in MDD subjects.

Interventions

  • Drug Ketamine
    A single intravenous (IV) infusion of ketamine calculated at 0.5mg/kg through an indwelling catheter over a 40-100min period.
  • Other Placebo
    A single intravenous (IV) infusion of saline through an indwelling catheter over a 40-100min period.

Primary outcome measures

  • Change in glutamate concentration in the medial prefrontal cortex (mPFC) [Time frame: Baseline, 24 hours post-infusion, 14 days post-infusion]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Other

Study locations

United States · 1 center
  • Emory University — Atlanta

Identifiers

NCT: NCT05327699 · STUDY00003476 · R01MH126083-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗