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Contact Information:

Prof Phil Cowen
phil.cowen@psych.ox.ac.uk


Dr Nisha Singh
Nisha.singh@psych.ox.ac.uk


Ms Beata Godlewska
beata.godlewska@psych.ox.ac.uk


Study Location:

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Be Part of Research - Trial Details - IMPase in treatment-resistant depression

IMPase in treatment-resistant depression

Completed

Open to: Female / Male

Age: 18 Years - 70 Years

Medical Conditions

Mood [affective] disorders


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Depression is a mental health condition that is associated with a substantial burden of suffering for both patients and their families. Most patients with depression do well with first line treatments such as psychotherapy or antidepressant medication but for those who are not helped sufficiently there are few effective and acceptable next step treatments. For patients who do not respond to antidepressants (and have so-called ‘treatment-resistant depression’), a drug called lithium is an effective ‘add-on’ therapy. However, lithium has some problematic side effects and requires blood test monitoring which reduces its usefulness. Greater knowledge of how lithium works in treatment resistant depression would help in the development in new medicines with an improved safety profile.

Our team at Oxford has been studying a drug called ebselen, which has as the ability to block an enzyme called IMPase. Animal experimental research has suggested that blockade of IMPase might be the basis of lithium’s antidepressant action. Ebselen was originally developed for the treatment of stroke and appears safe, with very few reported side-effects. It is therefore a useful way of finding out if IMPase inhibition could be a potential antidepressant mechanism. To take a first step in finding out if this could be the case we propose to use an ‘experimental medicine’ approach where we will examine the effects of a brief period (seven days) of ‘add-on’ ebselen treatment in patients with resistant depression to see if ebselen produces changes in emotional responses consistent with a potential clinical antidepressant effect. We will also seek to confirm ebselen’s mode of action on IMPase by measuring changes in a brain chemical called inositol, using a magnetic imaging method. Positive results from this study could lead to the development of selective IMPase inhibitors for the treatment of depression.

The study is funded by Medical Research Council.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

11 Apr 2021 31 May 2024

Interventional

Interventional type: Drug;



You can take part if:



You may not be able to take part if:


- History of /or current DSM-5 bipolar disorder, schizophrenia or emotionally unstable personality disorder; - Participants who fulfil current criteria for other comorbid disorders may still be entered into the study, if, in the opinion of the Investigator, the psychiatric diagnosis will not compromise safety or affect data quality; - Participants who have failed to respond to standard pharmacological augmentation treatments for depression (lithium and atypical antipsychotic drugs); - Clinically significant risk of suicide; - Participants undergoing or who have undergone electroconvulsive therapy for the treatment of the current episode of depression; - History of significant alcohol/substance misuse or dependence over the past 6 months; - History of, or current general medical conditions that in the opinion of the Investigator may interfere with the safety of the participant or the scientific integrity of the study; - Current pregnancy (as determined by urine pregnancy test taken during the Screening Visit and the Research Visit One), breastfeeding, or planning a pregnancy during the course of the study; - Participants with Body Mass Index (BMI – kg/m2) outside the 18-36 range at Screening Visit; - Participants with severe claustrophobia; - Participants who are contraindicated for MRI; - Previous participation in a study using the same, or similar, emotional processing tasks; - Previous participation in a study involving the use of an interventional medication within the last three months; - Participant with planned medical treatment within the study period that might interfere with the study procedures; - Participant who is unlikely to comply with the clinical study protocol or is unsuitable for any other reason, in the opinion of the Investigator.


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

Dr Nisha Singh
Nisha.singh@psych.ox.ac.uk


Prof Phil Cowen
phil.cowen@psych.ox.ac.uk


Ms Beata Godlewska
beata.godlewska@psych.ox.ac.uk



The study is sponsored by University of Oxford and funded by Medical Research Council (MRC) .




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for Trial ID: CPMS 45394

Last updated 21 November 2024

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