Depressive DisorderSIGNATURENCT05870501
Synaptic Imaging and Network Activity in Treatment Resistant Depression
A study testing Ketamine and Midazolam in people with Depressive Disorder and Depressive Disorder, Major, run by King's College London at 1 site in United Kingdom.
Trial summary
The main aim of this research is to explore the effects that ketamine has on the functional connectivity of the brain in participants with treatment resistant depression (TRD). This study will investigate the relationship between these changes and response to treatment as measured by clinical scales, as well as… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Depressive Disorder, Depressive Disorder, Major, Depressive Disorder, Treatment-Resistant
- What is being tested?
- Ketamine and Midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Oct 2021to 13 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Be male or female, aged between 18 and 55 years of age inclusive.
- Have a diagnosis of MDD, Bipolar 1 or Bipolar 2 depression and fulfil criteria for TRD depression. TRD patients are defined as having inadequately responded to at least two courses of antidepressants, given in a therapeutic dose and duration (Fekadu et al., 2018).
- Have moderate to severe depression symptoms as demonstrated by a MADRS score greater than 20.
- Be physically healthy, defined as having no clinically relevant abnormalities identified by a detailed medical history and full examination including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests
- Have a good command of the English language.
- Have no or very little knowledge of the Chinese language.
- Provide a personally signed and dated informed consent document indicating that the participant has been informed of and agrees to comply with all aspects of the study.
- Be willing and able to comply with scheduled visits, dosing plan, laboratory trials and any other necessary procedures.
Who cannot join
- Have a current diagnosed psychiatric disorder, except MDD, Bipolar 1 and Bipolar 2 disorders and comorbid generalised anxiety disorder (GAD), social anxiety and/or social phobia.
- Have a current or previously diagnosed psychotic disorder: Schizophrenia, Schizoaffective Disorder, Delusional disorder, Schizophreniform disorder, Schizotypal (personality) disorder, or Brief psychotic disorder.
- Have previously failed Ketamine as an antidepressant treatment given at a therapeutic dose.
- Have previously experienced an adverse response to ketamine and/or midazolam.
- Have scored 70 or lower in the WASI at the screening visit.
- Have one or more immediate family members with a current or previously diagnosed psychotic disorder.
Show all 30Show fewer
- Have a medically significant condition which renders them unsuitable for the study (e.g., diabetes, severe cardiovascular disease, severe respiratory disease (e.g. COPD), hepatic or renal failure etc.).
- Be pregnant or breastfeeding, if female.
- Have any MR contra-indications (e.g., metal implants, pacemakers, claustrophobia etc.) which would render them unsuitable for the study.
- Currently consume alcohol in excess of 28 units a week or more than 6 cups of caffeinated drinks per day.
- Smoke more than 5 cigarette per day
- Have taken illicit drugs 7 days prior to admission or current use of drugs of abuse including amphetamines, MDMA, cannabis and opioids Have taken any other medication during the course of the study that has not been discussed. This should be documented by the investigators. (As an exception, 1g paracetamol/24 hours may be taken up to 24 hours prior to any visit).
- Have consumed alcohol or caffeine within 12h and/or nicotine 4h hours prior to the screening visit, study day 1, 2 and 3 and each infusion visit until discharged at the end of each of those visits.
- Have consumed grapefruit juice or Seville oranges-containing products 24 hours prior to admission.
- Have used any prescribed medication in the 3 weeks prior to enrolment or non-prescription medication (other than paracetamol) in the previous 7 days, excluding medication prescribed for bipolar I and II and MDD.
- Have a significant history of drugs of abuse (including benzodiazepines) or positive drugs of abuse test.
- Have received another new chemical entity in the 1 month before dosing or taken part in another research study using drugs within 1 month before dosing.
- Have an acute illness within 2 weeks before the start of study.
- Have any clinically significant abnormalities in clinical chemistry (including liver function tests), haematology or urinalysis results.
- Have self-reported HIV, hepatitis B or hepatitis C
- Have a definite or suspected personal or family history of intolerance or hypersensitivity to drugs and/or their excipients, judged to be clinically relevant by the investigator.
- Have a history or presence of gastrointestinal, hepatic or renal disease or other condition known to interfere with absorption, distribution, metabolism or excretion of drugs.
- Have uncontrolled hypertension, or supine systolic BP outside of the range of 90 to 140 mmHg and a supine diastolic BP outside the range of 40 to 90 mmHg, after a period of acclimatisation.
- Have a decrease in systolic BP of > 25 mmHg or a decrease in diastolic BP of > 15 mmHg when going from resting in bed to standing position, with or without symptoms such as dizziness or light- headedness. (For determination of orthostatic hypotension, lying and standing BP will be recorded after the subject has rested for 10 minutes and has had resting BP recorded followed by measurements 5 minutes after standing)
- Have had treatment in the previous 3 months with any drug known to have a well-defined potential for hepatotoxicity (e.g., halothane).
- Have a risk of suicide according to the investigator's clinical judgment (eg, per C-SSRS positive answer on question 5 within 6 months or has made a suicide attempt within 6 months prior to screening visit).
- Have started a course of hormone replacement therapy within 8 weeks prior to the screening visit.
- Be a subject who, in the opinion of the investigator, should not participate in the study for reasons of safety.
- Have a score of more than 20 on the YMRS at study day 1 and at each subsequent assessment
- Be a subject who, in the opinion of the investigator, has a significant history of mixed episodes.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Institute of Psychiatry, Psychology & Neuroscience, King's College London
London, SE5 8AF
About this study
Official title: Synaptic Imaging and Brain Network Activity Following Ketamine in Treatment Resistant Depression
The main aim of this research is to explore the effects that ketamine has on the functional connectivity of the brain in participants with treatment resistant depression (TRD). This study will investigate the relationship between these changes and response to treatment as measured by clinical scales, as well as examining drug induced changes in reward and emotion based brain activity, structural connectivity, cerebral blood flow, cognition, metabolism and blood markers of brain plasticity.
Read the detailed description
A double-blind active-placebo crossover design will be used to study a single group of people with TRD to assess the effects of ketamine on brain networks activity versus an active placebo (midazolam). Participants will receive three separate IV infusions of ketamine (0.5mg/kg) followed by three separate IV infusions of an active placebo (midazolam (0.045mg/kg)), or 3 IV infusions of midazolam followed by 3 IV infusions of ketamine. Treatment order will be randomized in a crossover design.
The study will consist of 11 visits including a screening visit, baseline assessments, and two main infusion periods each involving 3 separate IV infusions and a post infusion assessment visit 24 hrs after the third infusion. Ketamine or midazolam will be administered at each of the infusion periods in a crossover design.
Assessment visits will include MRI, EEG and cognitive and clinical assessments.
Up to 50 subjects will be enrolled to ensure that evaluable data is obtained from 45 subjects. The primary comparison will be within-subject between active treatment and placebo.
- Conditions
- Depressive Disorder, Depressive Disorder, Major, Depressive Disorder, Treatment-Resistant, Bipolar Disorder, Bipolar Disorder I, Bipolar Disorder II
- Keywords
- Depression, Bipolar Disorder, Major Depressive Disorder, MDD, Treatment-Resistant Depression, Ketamine
- Medical subject headings
- Depressive Disorder, Depressive Disorder, Major, Depressive Disorder, Treatment-Resistant, Bipolar Disorder, Mood Disorders, Anhedonia, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ketamine followed by midazolam | Experimental | Ketamine 0.5mg/kg (three IV infusions) followed by midazolam 0.045mg/kg (three IV infusions) Receives: Drug: Ketamine; Drug: Midazolam |
| Midazolam followed by ketamine | Experimental | Midazolam 0.045mg/kg (three IV infusions) follower by ketamine 0.5mg/kg (three IV infusions) Receives: Drug: Ketamine; Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the effects of ketamine on brain resting state functional magnetic resonance imaging (fMRI) connectivity in patients with depression compared to placebo
Change in resting state connectivity measured with fMRI
Measured: Baseline and 24 hours post third IV infusion
Secondary outcomes (16)
To investigate the effects of ketamine on fMRI task-based activity during an emotional processing task compared to placebo
Changes in task related fMRI activity using an emotional processing task (Region of Interest (ROIs): Anterior cingulate cortex (ACC), medial frontal cortex; whole brain analysis)
Measured: Baseline and 24 hours post third IV infusion
To investigate the effects of ketamine on fMRI task-based activity during a reward-processing task compared to placebo
Changes in task related fMRI activity using a reward processing task. (Regions of interest (ROIs): striatal, thalamic and prefrontal regions; whole brain analysis)
Measured: Baseline and 24 hours post third IV infusion
To investigate the effects of ketamine on prolactin levels
Blood samples analysed for prolactin levels at baseline, pre third infusion and post third infusion of ketamine and placebo
Measured: Baseline and 40 minutes post third IV infusion
To investigate the effects of ketamine on anhedonic symptoms (as measured by SHAPS) compared to placebo
The Snaith-Hamilton Pleasure Scale (SHAPS) is a self report scale of hedonic experience and is assessed at baseline and 24 hrs post infusion of ketamine and placebo. The scale ranges from 14-56, with a higher score indicating higher levels of anhedonia
Measured: Baseline and 24 hours post third IV infusion
To investigate the effects of ketamine on depression symptoms (as measured by MADRS) compared to placebo
The Montgomery-Asberg Depression Rating Scale is a interview based scale of depression symptoms and is assessed at baseline of each session and 24 hrs post infusion of ketamine and placebo. The scale ranges from 0-60, with a higher score indicating an higher severity of depression symptoms.
Measured: Baseline and 24 hours post third IV infusion
To investigate the effects of ketamine on depression symptoms (as measured by QIDS) compared to placebo
The Quick Inventory of Depressive Symptomatology-Self Report (QIDS) is a self report scale of depression symptoms and is assessed at baseline, pre infusion and 24 hrs post third infusion of ketamine and placebo The scale ranges from 0-42, with a higher score indicating an higher severity of depression symptoms.
Measured: Baseline, pre infusion and 24 hours post third IV infusion
To investigate the effects of ketamine on the M3VAS compared to placebo
The Maudsley 3-item Visual Analogue Scale (M3VAS) is a self report visual analogue scale (VAS) of three main domains of depression symptoms (mood, pleasure and suicidality) and is assessed at baseline, pre infusion and 24 hrs post third infusion of ketamine and placebo. The VAS ranges from 0-100 on each domain, with a higher score indicating an higher severity of that domain.
Measured: Baseline, pre infusion and 24 hours post third IV infusion
To investigate the effects of ketamine on brain perfusion (ASL) compared to placebo
Arterial spin labelling (ASL) is a measure of blood flow or perfusion in the brain. Measures are taken at baseline and 24 hours post third infusion of ketamine and placebo
Measured: Baseline and 24 hours post third IV infusion
To investigate the blood plasma concentration (μg/mL) of ketamine following the third IV infusion
Blood samples will be taken to measure the blood concentration of ketamine at specific time points post infusion
Measured: 40 minutes, 120 minutes, 200 minutes and 24 hours post third IV infusion
To investigate the blood plasma concentration (μg/mL) of hydroxynorketamine following the third IV infusion
Blood samples will be taken to measure the blood concentration of hydroxynorketamine (a metabolite of ketamine) at specific time points post infusion
Measured: 40 minutes, 120 minutes, 200 minutes and 24 hours post third IV infusion
To investigate the blood plasma concentration (μg/mL) of norketamine following the third IV infusion
Blood samples will be taken to measure the blood concentration of norketamine (a metabolite of ketamine) at specific time points post infusion
Measured: 40 minutes, 120 minutes, 200 minutes and 24 hours post third IV infusion
To investigate the effects of ketamine on a short battery of cognitive tasks compared to placebo
The Cognition is a self administered web-based battery of cognitive tasks that will be conducted at baseline, and 24 hours post third infusion of ketamine and placebo
Measured: Baseline 24 hours post third IV infusion
To investigate the effects of ketamine on blood biomarkers related to synaptogenesis compared to placebo
Blood samples taken at baseline and 24 hours post third infusion of ketamine and placebo will be analysed for markers of synaptic plasticity (Brain derived neurotrophic factor (BDNF))
Measured: Baseline and 24 hours post third IV infusion
To investigate the effects of ketamine on the power of frequency bands (alpha, theta, gamma) in resting EEG
Electroencephalogram (EEG) is an brain imaging technique that allows the recording of brain electrical activity and will be conducted at baseline, and 24 hours post third infusion of ketamine and placebo
Measured: Baseline and 24 hours post third IV infusion
To investigate the effects of ketamine on structural connectivity (DTI) compared to placebo
Diffusion tensor imaging (DTI) is a measure of brain tissue microstructure. Measures are taken at baseline and 24 hours post third infusion of ketamine and placebo
Measured: Baseline and 24 hours post third IV infusion
To investigate the effects of ketamine on visual and auditory based ERPs compared to placebo
Event related potentials (ERPs) are an EEG measure related to brain electrical activity that can be produced by visual and auditory stimuli
Measured: Baseline and 24 hours post third IV infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start20 Oct 2021
- Primary completion13 Sep 2023
- Study completion13 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A double-blind active-placebo crossover design will be used to study a single group of people with TRD to assess the effects of ketamine on brain networks activity versus an active placebo (midazolam). Participants will be randomised to receive three separate IV infusions of ketamine (0.5mg/kg) followed by three separate IV infusions of midazolam (0.045mg/kg), or three separate infusions of midazolam followed by three separate infusions of ketamine.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Mitul Mehta, PhD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05870501
- Sponsor's protocol ID
- 297200
- Acronym
- SIGNATURE
- Status last verified
- Sep 2023
- First submitted
- 6 Mar 2023
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synaptic Imaging and Brain Network Activity Following Ketamine in Treatment Resistant Depression
- ClinicalTrials.gov ID
- NCT05870501
- Acronym / sponsor ID
- SIGNATURE / 297200
- Conditions
- Depressive Disorder, Depressive Disorder, Major, Depressive Disorder, Treatment-Resistant, Bipolar Disorder, Bipolar Disorder I, Bipolar Disorder II
- Keywords
- Depression, Bipolar Disorder, Major Depressive Disorder, MDD, Treatment-Resistant Depression, Ketamine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- 13 Sep 2023 (actual)
- Study completion
- 13 Sep 2023 (actual)
- First posted
- 23 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main aim of this research is to explore the effects that ketamine has on the functional connectivity of the brain in participants with treatment resistant depression (TRD). This study will investigate the relationship between these changes and response to treatment as measured by clinical scales, as well as examining drug induced changes in reward and emotion based brain activity, structural connectivity, cerebral blood flow, cognition, metabolism and blood markers of brain plasticity.
Detailed description
A double-blind active-placebo crossover design will be used to study a single group of people with TRD to assess the effects of ketamine on brain networks activity versus an active placebo (midazolam). Participants will receive three separate IV infusions of ketamine (0.5mg/kg) followed by three separate IV infusions of an active placebo (midazolam (0.045mg/kg)), or 3 IV infusions of midazolam followed by 3 IV infusions of ketamine. Treatment order will be randomized in a crossover design.
The study will consist of 11 visits including a screening visit, baseline assessments, and two main infusion periods each involving 3 separate IV infusions and a post infusion assessment visit 24 hrs after the third infusion. Ketamine or midazolam will be administered at each of the infusion periods in a crossover design.
Assessment visits will include MRI, EEG and cognitive and clinical assessments.
Up to 50 subjects will be enrolled to ensure that evaluable data is obtained from 45 subjects. The primary comparison will be within-subject between active treatment and placebo.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A double-blind active-placebo crossover design will be used to study a single group of people with TRD to assess the effects of ketamine on brain networks activity versus an active placebo (midazolam). Participants will be randomised to receive three separate IV infusions of ketamine (0.5mg/kg) followed by three separate IV infusions of midazolam (0.045mg/kg), or three separate infusions of midazolam followed by three separate infusions of ketamine.
| Arm | Type | Receives |
|---|---|---|
| Ketamine followed by midazolam | Experimental | Drug: Ketamine, Drug: MidazolamKetamine 0.5mg/kg (three IV infusions) followed by midazolam 0.045mg/kg (three IV infusions) |
| Midazolam followed by ketamine | Experimental | Drug: Ketamine, Drug: MidazolamMidazolam 0.045mg/kg (three IV infusions) follower by ketamine 0.5mg/kg (three IV infusions) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Be male or female, aged between 18 and 55 years of age inclusive.
- Have a diagnosis of MDD, Bipolar 1 or Bipolar 2 depression and fulfil criteria for TRD depression. TRD patients are defined as having inadequately responded to at least two courses of antidepressants, given in a therapeutic dose and duration (Fekadu et al., 2018).
- Have moderate to severe depression symptoms as demonstrated by a MADRS score greater than 20.
- Be physically healthy, defined as having no clinically relevant abnormalities identified by a detailed medical history and full examination including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests
- Have a good command of the English language.
Key exclusion criteria (30 listed)
- Have a current diagnosed psychiatric disorder, except MDD, Bipolar 1 and Bipolar 2 disorders and comorbid generalised anxiety disorder (GAD), social anxiety and/or social phobia.
- Have a current or previously diagnosed psychotic disorder: Schizophrenia, Schizoaffective Disorder, Delusional disorder, Schizophreniform disorder, Schizotypal (personality) disorder, or Brief psychotic disorder.
- Have previously failed Ketamine as an antidepressant treatment given at a therapeutic dose.
- Have previously experienced an adverse response to ketamine and/or midazolam.
- Have scored 70 or lower in the WASI at the screening visit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketamine0.5mg/kg IV infusion | Drug | Ketamine followed by midazolam, Midazolam followed by ketamine |
| Midazolam0.045mg/kg IV infusion | Drug | Ketamine followed by midazolam, Midazolam followed by ketamine |
Primary outcome
To investigate the effects of ketamine on brain resting state functional magnetic resonance imaging (fMRI) connectivity in patients with depression compared to placebo
Time frame: Baseline and 24 hours post third IV infusion
Change in resting state connectivity measured with fMRI
16 secondary outcomes
To investigate the effects of ketamine on fMRI task-based activity during an emotional processing task compared to placebo
Time frame: Baseline and 24 hours post third IV infusion
To investigate the effects of ketamine on fMRI task-based activity during a reward-processing task compared to placebo
Time frame: Baseline and 24 hours post third IV infusion
To investigate the effects of ketamine on prolactin levels
Time frame: Baseline and 40 minutes post third IV infusion
To investigate the effects of ketamine on anhedonic symptoms (as measured by SHAPS) compared to placebo
Time frame: Baseline and 24 hours post third IV infusion
To investigate the effects of ketamine on depression symptoms (as measured by MADRS) compared to placebo
Time frame: Baseline and 24 hours post third IV infusion
To investigate the effects of ketamine on depression symptoms (as measured by QIDS) compared to placebo
Time frame: Baseline, pre infusion and 24 hours post third IV infusion
To investigate the effects of ketamine on the M3VAS compared to placebo
Time frame: Baseline, pre infusion and 24 hours post third IV infusion
To investigate the effects of ketamine on brain perfusion (ASL) compared to placebo
Time frame: Baseline and 24 hours post third IV infusion
To investigate the blood plasma concentration (μg/mL) of ketamine following the third IV infusion
Time frame: 40 minutes, 120 minutes, 200 minutes and 24 hours post third IV infusion
To investigate the blood plasma concentration (μg/mL) of hydroxynorketamine following the third IV infusion
Time frame: 40 minutes, 120 minutes, 200 minutes and 24 hours post third IV infusion
To investigate the blood plasma concentration (μg/mL) of norketamine following the third IV infusion
Time frame: 40 minutes, 120 minutes, 200 minutes and 24 hours post third IV infusion
To investigate the effects of ketamine on a short battery of cognitive tasks compared to placebo
Time frame: Baseline 24 hours post third IV infusion
To investigate the effects of ketamine on blood biomarkers related to synaptogenesis compared to placebo
Time frame: Baseline and 24 hours post third IV infusion
To investigate the effects of ketamine on the power of frequency bands (alpha, theta, gamma) in resting EEG
Time frame: Baseline and 24 hours post third IV infusion
To investigate the effects of ketamine on structural connectivity (DTI) compared to placebo
Time frame: Baseline and 24 hours post third IV infusion
To investigate the effects of ketamine on visual and auditory based ERPs compared to placebo
Time frame: Baseline and 24 hours post third IV infusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mitul Mehta, PhD principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketamine and Midazolam in people with Depressive Disorder and Depressive Disorder, Major, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate the effects of ketamine on brain resting state functional magnetic resonance imaging (fMRI) connectivity in patients with depression compared to placebo (time frame: Baseline and 24 hours post third IV infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024; AzTrials last refreshed its copy on 26 Oct 2026.