{"id":1059,"date":"2024-03-20T09:59:38","date_gmt":"2024-03-20T09:59:38","guid":{"rendered":"https:\/\/oxfordhealth.nhs.uk\/rd\/?page_id=1059"},"modified":"2025-03-10T17:54:30","modified_gmt":"2025-03-10T17:54:30","slug":"ongoing-cris-projects-mood-disorders","status":"publish","type":"page","link":"https:\/\/oxfordhealth.nhs.uk\/research\/toolkit\/cris\/ongoing-cris-projects-mood-disorders\/","title":{"rendered":"Ongoing CRIS projects: mood disorders"},"content":{"rendered":"

Conducting a study of people with depression who appear not to be getting better on a single medication<\/strong><\/h2>\n

\u00a0<\/strong>In clinical trials of treatments for people with mental illness, a group of patients are given a treatment (called the \u201cintervention arm\u201d of the trial) and compared to another different group who are given an inactive or placebo (the \u201ccontrol arm\u201d).\u00a0 At the end of the trial the patients in both arms are compared to see if the treatment made a difference to their symptoms or overall quality of life. Importantly, the comparison allows side effects and adverse events to be monitored thus establishing the safety of the treatment.\u00a0 Participating in clinical trials can be burdensome for patients and usually there are no immediate treatment benefits for volunteering.\u00a0 Results from controlled clinical trials are often criticized because the patients enrolled are not sufficiently representative of the patients who might receive the treatment in the future.\u00a0 Finally, existing trials can be inefficient because often, for every patient in the intervention arm, many more patients are required in the control arm to make statistically valid comparisons.<\/p>\n

Consequently, researchers have sought ways to make trials more efficient and at the same time make results more applicable to \u201creal world\u201d clinical practice.\u00a0 One approach is to conduct a traditional clinical trial, but at the same time, enroll a group of patients who won\u2019t be given the experimental treatment.\u00a0 These patients will continue their existing treatment in the usual way they would in the NHS and these participants form what is known as an\u00a0external control arm\u00a0<\/em>(ECA).\u00a0 At the end of the trial researchers can then compare people in the treatment arm with those in the ECA to examine the frequency of side-effects, changes in symptoms and safety data for patients who had their usual treatment.\u00a0 For example, if researchers think a new medication might cause people to faint, they can see how many people fainted in the intervention arm and compare this statistically to those in the ECA. Additionally, many illnesses fluctuate over time so patients in the external control arm can add valuable information about the natural time course of symptoms and adverse events when looking for clinically meaningful differences when compared to participants in the treatment arm.<\/p>\n

Oxford Health NHS Foundation Trust (OHFT) and the University of Oxford have partnered with Akrivia Health (an Oxford-based health technology company) to deliver an external control arm for a study sponsored by Janssen, a pharmaceutical company.\u00a0 Janssen are conducting a study of people with depression who appear not to be getting better on a single medication.\u00a0 We will approach patients who are treated by OHFT to see if they would consider being a participant in this external control arm.\u00a0 Participants will continue their care and treatment with their NHS team and participation in the study will not modify their current or any future treatment plans with their team.\u00a0 Participants will be asked to attend a series of regular interviews with the study team, over approximately one year and to have blood tests \u2013 as they would in a traditional clinical trial and these are in addition to their usual care or treatment plan.<\/p>\n

In addition, each participant will be asked if their anonymised medical records can be examined at regular intervals using technology developed by Akrivia Health in collaboration with the team at OHFT and the University of Oxford.\u00a0\u00a0 Through examination of these records it is hoped\/anticipated that patterns of adverse events like falls, sleep problems or worsening of depression symptoms can be detected.<\/p>\n

Only summary numerical data will be extracted from participant\u2019s medical records (for example, the number of times the participant had outpatient appointments with their team; a list of current medication and doses; any descriptions of side-effects of treatment).\u00a0\u00a0 Data that describes a person or is unique to them (e.g. their date of birth or NHS number) will not be extracted or disclosed to the sponsor (Janssen) and Akrivia Health will not be able to determine the identity of a patient or access the participant\u2019s source medical notes.\u00a0 Similarly, any summary data that could\u00a0 \u2013 in combination\u00a0\u2013\u00a0\u00a0<\/em>be used to identify the participant will not be provided to the sponsor; for example, very specific symptoms, the participants address or occupation.<\/p>\n

The study\u2019s sponsor (Janssen) will benefit by having data from the external control arm that describes how patients progress in terms of side-effects, adverse events and healthcare contact when they continue their normal NHS standard of care for the treatment of depression.\u00a0 The results of this study will enable researchers at OHFT and the University of Oxford to establish if external control arms are feasible, practical and add important information to traditional clinical trials that could bring about benefit for patients in the future.<\/p>\n","protected":false},"excerpt":{"rendered":"

Conducting a study of people with depression who appear not to be getting better on a single medication \u00a0In clinical trials of treatments for people with mental illness, a group of patients are given a treatment (called the \u201cintervention arm\u201d of the trial) and compared to another different group who are given an inactive or […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":160,"menu_order":4,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_relevanssi_hide_post":"","_relevanssi_hide_content":"","_relevanssi_pin_for_all":"","_relevanssi_pin_keywords":"","_relevanssi_unpin_keywords":"","_relevanssi_related_keywords":"","_relevanssi_related_include_ids":"","_relevanssi_related_exclude_ids":"","_relevanssi_related_no_append":"","_relevanssi_related_not_related":"","_relevanssi_related_posts":"","_relevanssi_noindex_reason":"","footnotes":""},"class_list":["post-1059","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/oxfordhealth.nhs.uk\/research\/wp-json\/wp\/v2\/pages\/1059","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/oxfordhealth.nhs.uk\/research\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/oxfordhealth.nhs.uk\/research\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/oxfordhealth.nhs.uk\/research\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/oxfordhealth.nhs.uk\/research\/wp-json\/wp\/v2\/comments?post=1059"}],"version-history":[{"count":2,"href":"https:\/\/oxfordhealth.nhs.uk\/research\/wp-json\/wp\/v2\/pages\/1059\/revisions"}],"predecessor-version":[{"id":1410,"href":"https:\/\/oxfordhealth.nhs.uk\/research\/wp-json\/wp\/v2\/pages\/1059\/revisions\/1410"}],"up":[{"embeddable":true,"href":"https:\/\/oxfordhealth.nhs.uk\/research\/wp-json\/wp\/v2\/pages\/160"}],"wp:attachment":[{"href":"https:\/\/oxfordhealth.nhs.uk\/research\/wp-json\/wp\/v2\/media?parent=1059"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}