CompletedNot Applicable

Synaptic Imaging and Network Activity in Treatment Resistant Depression

United Kingdom56 participantsStarted 2021-10-20

Plain-language 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 examining drug induced changes in reward and emotion based brain activity, structural connectivity, cerebral blood flow, cognition, metabolism and blood markers of brain plasticity.

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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 dis…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To investigate the effects of ketamine on brain resting state functional magnetic resonance imaging (fMRI) connectivity in patients with depression compared to placebo

Timeframe: Baseline and 24 hours post third IV infusion

Trial details

NCT IDNCT05870501

SponsorKing's College London

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-09-13

View on ClinicalTrials.gov More Depressive Disorder trials