Actively Recruiting
Glutamate Emotion Memory Study
Led by University of Oxford · Updated on 2024-05-21
60
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Clinical depression often includes a pessimistic view of things which have happened in the past and an impairment in the ability to experience pleasure or looking forward to things. A licensed drug called ketamine affects the levels of glutamate, a chemical messenger in the brain, and has been used as a treatment particularly for depression which hasn't got better with other types of medication. Glutamate plays a role in learning and memory so the investigators are interested in understanding how ketamine can affect how people with depression remember past negative and positive memories and how they experience reward. The investigators are conducting a study in depressed participants who did not improve with the standard antidepressant treatment to expand our understanding on how ketamine can influence memory, the way people understand emotions and learn from rewards and punishments. Study participants will undergo medical and psychiatric health screening, drug administration (ketamine or saline), questionnaires and computer tasks before and after the administration of the study drug, and an MRI scan after administration of the drug. MRI is a type of brain scan that allows us to see how the brain responds during for example memories of things which have happened in the past. This project will help us understand how NMDA antagonists may work in depression.
CONDITIONS
Official Title
Glutamate Emotion Memory Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to give informed consent for participation in the study
- Sufficiently fluent English to understand and complete the tasks
- Registered with a GP and consents to GP being informed of participation in the study
- Current diagnosis of Major Depressive Disorder in a major depressive episode as determined by SCID-5
- Inadequate response to one to three antidepressant treatments
- Currently taking a licensed antidepressant at a therapeutic dose for at least four weeks
- Pre-menopausal women and males with risk of pregnancy must use a highly effective contraception method from screening until 30 days after treatment
- Male participants must not donate sperm until 30 days after treatment
- Participants may be on other medications if judged safe by the Investigator
- Willingness to refrain from driving, cycling, or operating heavy machinery until the following morning or restful sleep
- Willingness to avoid alcohol for 3 days before infusion and 1 day before other study visits
You will not qualify if you...
- History or current diagnosis of bipolar disorder, schizophrenia, or emotionally unstable personality disorder
- Diagnosis of major cognitive disorder or cognitive impairment
- Clinically significant risk of suicide
- Undergoing or have undergone electroconvulsive therapy for current depression episode
- Substance or alcohol use disorder in the past 6 months
- Regular alcohol intake over 21 units per week or inability to abstain from alcohol as required
- Smoking more than 10 cigarettes per day
- Medical conditions that may interfere with safety or study integrity
- Current pregnancy, breastfeeding, planning pregnancy, or unwillingness to use birth control
- Clinically significant abnormalities in lab tests, physical exam, or ECG unless deemed safe by Investigator
- History or presence of heart rhythm disorders
- Untreated clinically significant hypertension
- Contraindications to MRI such as claustrophobia or magnetic implants
- Previous participation in similar emotional processing studies within 3 months
- Previous lifetime use of ketamine or phencyclidine
- Planned medical treatments during study that interfere with procedures
- Unlikely to comply with study protocol or unsuitable per Investigator opinion
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Trial Site Locations
Total: 1 location
1
Department of Psychiatry, University of Oxford
Oxford, United Kingdom
Actively Recruiting
Research Team
S
Sara Costi, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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