RECRUITING

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

Conditions

Major Depressive Disorder Neuroscience Stress response

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2022-11-08

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05327699

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* willing and able to give written informed consent * men or women,18-65 years of age * primary diagnosis of DSM (Diagnostic and Statistical Manual of Mental Disorders)-V MDD, current, as diagnosed by the SCID-I (Structured Clinical Interview for DSM Disorders) * 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 * willing and able to give written informed consent * men or women, 18-65 years of age	* 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) * 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 (Mini-Mental State Exam) score \<28 * elevated blood pressure prior to infusion (systolic \> 160 or diastolic \>100) * history of treatment resistance as determined by ATRQ (Antidepressant Treatment Response Questionnaire) * prior adverse reaction to ketamine * use of antipsychotic medications * use of greater than 2mg daily of lorazepam or similar benzodiazipine * 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

Inclusion Criteria

Exclusion Criteria

* willing and able to give written informed consent
* men or women,18-65 years of age
* primary diagnosis of DSM (Diagnostic and Statistical Manual of Mental Disorders)-V MDD, current, as diagnosed by the SCID-I (Structured Clinical Interview for DSM Disorders)
* 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
* willing and able to give written informed consent
* men or women, 18-65 years of age

* 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)
* 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 (Mini-Mental State Exam) score \<28
* elevated blood pressure prior to infusion (systolic \> 160 or diastolic \>100)
* history of treatment resistance as determined by ATRQ (Antidepressant Treatment Response Questionnaire)
* prior adverse reaction to ketamine
* use of antipsychotic medications
* use of greater than 2mg daily of lorazepam or similar benzodiazipine
* 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

Contacts and Locations

Study Contact

Michael Treadway, PhD

CONTACT

(404) 727-7541

ketaminestudy@emory.edu

Principal Investigator

Michael Treadway, PhD

PRINCIPAL_INVESTIGATOR

Emory University

Study Locations (Sites)

Emory University

Atlanta, Georgia, 30322

United States

Collaborators and Investigators

Sponsor: Emory University

Michael Treadway, PhD, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-08

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2022-11-08

Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

Neuroscience
Stress response

Additional Relevant MeSH Terms

Major Depressive Disorder