An interventional study of Ketamine Hydrochloride and No intervention (placebo) in Treatment Resistant Depression, Depression and Major Depressive Disorder, sponsored by University of Oxford. Status unknown at 1 site in United Kingdom. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-05-21.
Sponsored by University of Oxford · Not applicable, Interventional, and Basic science
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.
Questions regarding the exact molecular mechanisms of ketamine and its effects on the brain circuitry and networks for the treatment of clinical depression remain largely unanswered. Thus, in the present study the investigators aim to elucidate the effect of ketamine on 1) reconsolidation of autobiographical memories, 2) connectivity of brain circuits involved in autobiographical memories, 3) measures of emotional processing, reward processing and emotional memory in patients suffering from treatment resistant depression. The ultimate goal of this project is to elucidate the antidepressant mechanisms of action of ketamine to facilitate the development of rapid acting antidepressants targeting the glutamatergic system.
472 studies on the registry are indexed under Depressive Disorder, Treatment-Resistant; 151 are open to participants now.
This study's planned enrollment of 60 is above the median of 51 across 397 interventional studies indexed under Depressive Disorder, Treatment-Resistant.
Browse Depressive Disorder, Treatment-Resistant studies →University of Oxford is the lead sponsor of 812 studies on the registry; 119 are open to participants now.
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Participants need to meet a number of concurrent clinical criteria:
Acceptable methods of contraception include:
Exclusion Criteria:
Participants in this arm will receive a single intravenous injection, antidepressant dose of Ketamine hydrochloride (0.5mg/kg)
Drug: Ketamine Hydrochloride
Participants in this arm will receive a single intravenous injection of an inactive placebo (0.9% sodium chloride)
Other: No intervention (placebo)
Ketamine is a high trapping NMDA receptor antagonist which has rapid and reliable antidepressant effects in patients with major depressive disorder (MDD) who fail to respond to at least two antidepressant trials of adequate dose and duration.
Placebo injection (0.9% sodium chloride)
Change in magnitude of negative and positive valence adjectives in the autobiographical memory task using a self-reported questionnaire.
To investigate the effects of ketamine on: \- negative emotional bias associated with autobiographical memories in TRD patients. Each negative (guilty/ashamed, depressed/sad, angry/frustrated, upset, anxious/worried, worthless) and positive (grateful, energetic/motivated, hopeful, confident, loved, happy) valence adjectives. will be rated on a scale from 0 to 100. Change in magnitude will be assessed calculating the difference in ratings of negative and positive adjectives using a self-reported questionnaire from baseline to after treatment
Time frame: -1 and 1 days after ketamine/placebo treatment
Brain activation as measured by functional magnetic resonance in a network of areas related to autobiographical memories, including the medial prefrontal cortex and associated networks during the autobiographical memory task.
To investigate the effects of ketamine on: \- on brain circuit associated with autobiographical memories
Time frame: 1 days after ketamine/placebo treatment
Accuracy on a computer-based task of facial expression recognition (FERT)
To investigate the effects of ketamine on: \- emotional processing such as emotional recognition.
Time frame: -1 day, and up to 2 hours after ketamine/placebo treatment
Reaction time on a computer-based task of facial expression recognition (FERT)
To investigate the effects of ketamine on: \- emotional processing such as emotional recognition.
Time frame: -1 day, and up to 2 hours after ketamine/placebo treatment
Accuracy to classify positive and negative descriptor words using the Emotional Categorisation Task (ECAT)
To investigate the effects of ketamine on: \- emotional processing such as classification of positive and negative descriptor words
Time frame: Up to 2 hours after ketamine/placebo treatment
Reaction time to classify positive and negative descriptor words using the Emotional Categorisation Task (ECAT)
To investigate the effects of ketamine on: \- emotional processing such as classification of positive and negative descriptor words
Time frame: Up to 2 hours after ketamine/placebo treatment
Number of positive and negative words correctly recalled (hits) and number of words incorrectly recalled (false alarms) using the Emotional Recall Task (EREC)
To investigate the effects of ketamine on: \- emotional processing such as recall of positive and negative descriptor words
Time frame: Up to 2 hours after ketamine/placebo treatment
Accuracy to correctly (hits) and incorrectly (false alarms) recognise positive and negative words using the Emotional Recognition Memory Task (EMEM)
To investigate the effects of ketamine on: \- emotional processing such as recognition of positive and negative descriptor words
Time frame: Up to 2 hours after ketamine/placebo treatment
Reaction time to correctly (hits) and incorrectly (false alarms) recognise positive and negative words using the Emotional Recognition Memory Task (EMEM)
To investigate the effects of ketamine on: \- emotional processing such as recognition of positive and negative descriptor words
Time frame: Up to 2 hours after ketamine/placebo treatment
Change in response choice during gain and loss using the Probabilistic Instrumental Learning Tasks (PILT)
To investigate the effects of ketamine on: \- reward processing
Time frame: 1 day after ketamine/placebo treatment
Brain activation as measured by functional magnetic resonance imaging during the Probabilistic Instrumental Learning Tasks (PILT) in reward-related brain areas, including the ventral striatum and associated networks
To investigate the effects of ketamine on: \- on brain circuit associated with reward processing
Time frame: 1 days after ketamine/placebo treatment
Explore performance on information processing and monetary win/loss reinforcement learning (RL) decision-making tasks.
To investigate the effects of ketamine on: \- choice behaviour on win and loss trials
Time frame: 1 days after ketamine/placebo treatment
Explore performance on information processing and monetary win/loss reinforcement learning (RL) decision-making tasks using pupillometry
To investigate the effects of ketamine on: \- pupil dilation in context of RL decision making task
Time frame: 1 days after ketamine/placebo treatment
Change in choice behaviour (effort and/or reward sensitivity) on accepted offers between session one and two using the Apples Gathering Task (AGT).
To investigate the effects of ketamine on: \- motivation processing
Time frame: Up to 2 hours after ketamine/placebo treatment and 7 days after ketamine/placebo treatment
This study is status unknown, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ketamine
Depressive Disorder, Treatment-Resistant →