Reward Emotion Learning and Ketamine Study (RELAKS)

March 24, 2023 updated by: Catherine Harmer, University of Oxford
Ketamine's efficacy as an antidepressant is now well established yet the mechanisms underlying its antidepressant effect are yet to be fully described. Work in the animal literature and research in humans is suggestive of specific effects on anhedonia and memory reconsolidation. In this study the investigators will further explore the effects of ketamine on learning and memory as well as measuring the associated changes at neural level in a sample of healthy volunteers. Participants will be assigned to receive ketamine or placebo and complete a set of tasks which will allow the investigators to quantify the effect of ketamine on learning about reward and punishment and memory for learned reward associations 24 hours after ketamine infusion. This study will help the investigators to understand the basis of ketamine's antidepressant effects and aid the development of new treatments for depression.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United Kingdom
      • Oxford, United Kingdom, OX3 7JZ
        • Recruiting
        • University of Oxford

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI between 18 and 30
  • Participant is willing and able to give informed consent for participation in the study
  • Sufficient knowledge of English language to understand and complete study tasks
  • Willingness to refrain from driving, cycling, or operating heavy machinery, until the following morning or a restful sleep has occurred, whichever is later.
  • Willingness to refrain from signing legal documents within 7 days after the infusion visit.
  • Willingness to refrain from drinking alcohol for 3 days before the infusion visit and one day before any of the other visits throughout the study

Exclusion Criteria:

  • Any current or past DSM-V significant psychiatric disorder including any psychotic, mood and anxiety and borderline personality disorders
  • History of, or current medical conditions which in the opinion of the investigator may interfere with the safety of the participant or the scientific integrity of the study, including epilepsy/seizures, brain injury, hepatic or renal disease, severe gastro-intestinal problems, Central Nervous System (CNS) tumours, neurological conditions
  • First-degree relative with a diagnosis of schizophrenia-spectrum or other psychotic disorder, or bipolar disorder
  • History of unexplained hallucinations or impulse control problems (e.g. pathological gambling)
  • Current or past history of heart rhythm disorders
  • Clinically significant hypertension
  • Increased intraocular pressure/glaucoma
  • Current pregnancy (as determined by urine pregnancy test taken during Screening and Infusion Visits) or breastfeeding
  • Clinically significant abnormal values for clinical chemistry (e.g. liver function tests), urine drug screen, blood pressure measurement and ECG. A participant with a clinical abnormality or parameters outside the reference range for the population being studied may be included only if the Investigator considers that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures
  • Current or previous intake (last three months) of any medication that has a significant potential to affect mental functioning (e.g. benzodiazepines, antidepressants, neuroleptics etc.)
  • Any intake of recreational drugs in the last 3 months (e.g. marijuana, ecstasy etc.)
  • Lifetime recreational use of ketamine or phencyclidine
  • Regular alcohol consumption of more than 14 units a week or excessive alcohol consumption up to three days before any of the in-person study visits
  • Inability to abstain from alcohol for more than 1 week
  • Regular smoker (> 5 cigarettes per day)
  • Excessive caffeine user (> 6 caffeinated drinks per day)
  • History of recurrent rashes or history of allergic reactions to relevant substances (ketamine treatment, placebo treatment)
  • Previous participation in a study using the same or similar tasks
  • Current participation in another study or participation in similar study within the last 6 months
  • Participant is unlikely to comply with the clinical study protocol or is unsuitable for any other reason, in the opinion of the Investigator
  • Claustrophobia
  • Any implants (including dental implants) or pacemaker
  • Tattoos above the chest
  • Any other MRI contraindications outlined in FMRIB 7 Tesla scanning safety form

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Ketamine
Participants in this arm will receive a single intravenous, antidepressant dose of ketamine hydrochloride (0.5mg/kg)
Drug: Ketamine Hydrochloride
Ketamine is a high trapping NMDA receptor antagonist which has rapid and reliable antidepressant effects in patients with major depressive disorder (MDD) who have failed to respond to conventional monoaminergic agents.
Placebo Comparator: Placebo
Participants in this arm will receive a single intravenous injection of an inactive placebo (0.9% sodium chloride).
Other: No intervention (placebo)
Placebo injection (0.9% sodium chloride)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Activation of the habenula during the Pavlovian conditioning task in response to the conditioned stimulus associated with pain stimuli and in response to the receipt of shock.
Time Frame: 24 hours after ketamine infusion
Blood Oxygen Level Dependent (BOLD) signal in the habenula at the time of the shock-associated conditioned stimulus presentation and at the time of shock delivery.
24 hours after ketamine infusion
Habenula response to the absence of expected reward and the receipt of an unexpected loss (i.e. a negative prediction error signal) in both the reward maximisation and loss minimisation tasks.
Time Frame: 24 hours after ketamine administration
BOLD signal in the habenula at the time of outcome presentation in both the reward maximisation and loss minimisation tasks.
24 hours after ketamine administration
Preference for high-reward probability shapes learned after winning money (in the Wheel of Fortune draw) during the preference test.
Time Frame: +/- 24 hours after ketamine administration
Proportion of choices where high-reward probability shapes are selected. This will be based on the difference between the perceived reward probability of shapes learned after the winning and losing of money (an area under the curve measure).
+/- 24 hours after ketamine administration

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ventral striatum response to the expected reward and the omission an unexpected loss (i.e. a positive prediction error signal) in both the reward maximisation and loss minimisation tasks.
Time Frame: 24 hours after ketamine administration
BOLD signal in the ventral striatum at the time of outcome presentation in both the reward maximisation and loss minimisation tasks.
24 hours after ketamine administration
Pupil dilation (measured by an eye tracker device) in response to decision values in the affective memory preference test.
Time Frame: 24 hours after ketamine administration
Baseline corrected pupil dilation measured at the time of option presentation during each choice trial of the affective memory preference test.
24 hours after ketamine administration
Difference in pupil response to shapes learned after winning versus losing money.
Time Frame: 24 hours after ketamine administration
Between groups comparison of pupil dilation in response to shapes learned after a loss and shapes learned after a win in Wheel of Fortune draw that induces experimental change in negative/positive affect.
24 hours after ketamine administration
Amount of money earned in the learning and memory task.
Time Frame: Final component completed 24 hours after ketamine administration before scanning
Between groups comparison of the total amount of money earned during the learning and memory task.
Final component completed 24 hours after ketamine administration before scanning
Change in bio-behavioral measures of stress following laboratory induced stress administered.
Time Frame: 1-week after ketamine infusion
Between groups comparison of salivary cortisol in response to Oxford Cognition Stress Task.
1-week after ketamine infusion
Change in bio-behavioral measures of stress following laboratory induced stress administered.
Time Frame: 1-week after ketamine infusion
Between groups comparison of salivary alpha amylase in response to Oxford Cognition Stress Task.
1-week after ketamine infusion
Change in bio-behavioral measures of stress following laboratory induced stress administered.
Time Frame: 1-week after ketamine infusion
Between groups comparison of heart rate in response to Oxford Cognition Stress Task.
1-week after ketamine infusion
Change in bio-behavioral measures of stress following laboratory induced stress administered.
Time Frame: 1-week after ketamine infusion
Between groups comparison of visual analogue scale ratings in response to Oxford Cognition Stress Task.
1-week after ketamine infusion
Recognition of positive and negative facial expressions.
Time Frame: Immediately and 24 hours after ketamine infusion
Recognition accuracy for positive and negative facial expressions
Immediately and 24 hours after ketamine infusion
Recognition of positive and negative facial expressions.
Time Frame: Immediately and 24 hours after ketamine infusion
Reaction time to recognise positive and negative facial expressions
Immediately and 24 hours after ketamine infusion
Categorisation of emotional words.
Time Frame: 24 hours after ketamine infusion
Accuracy of categorisation for positive and negative descriptor words.
24 hours after ketamine infusion
Recognition of emotional words.
Time Frame: 24 hours after ketamine infusion
Reaction time to categorise positive and negative descriptor words.
24 hours after ketamine infusion
Recall of emotional words.
Time Frame: 24 hours after ketamine infusion
Number of words correctly (hits) and incorrectly (false alarms) recalled.
24 hours after ketamine infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Oxford

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Medical Research Council
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 25, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 1, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RELAKS_HV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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