NCT07189689

Brief Summary

The current study aims to understand why some people with depression respond to treatment and others do not, using markers of clinical symptoms, both clinician reported outcome measures and patient reported outcome measures, demographic information, cognitive function, genetic sequence information (genomic), chemical measures of metabolism (metabolomic), protein makeup (proteomic) and the body's natural defence system (immune/inflammatory markers) together with collections of cells that will facilitate new research to drive improvements in diagnosis and treatment of mood disorders that may be proving difficult to treat. This will allow future clinical trials within the NHS, academia and industry to drive forward new approaches and treatments. Participants who provide consent for re-contact for future treatment trials and other research studies have the potential to benefit from this with participation in experimental studies and clinical trials associated with improved patient outcomes. Overall, the cohort will generally support greater access to research opportunities for a wider population of people.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
21mo left

Started Oct 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress26%
Oct 2025Jan 2028

First Submitted

Initial submission to the registry

July 31, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 24, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2028

Last Updated

October 3, 2025

Status Verified

September 1, 2025

Enrollment Period

2.3 years

First QC Date

July 31, 2025

Last Update Submit

September 29, 2025

Conditions

Keywords

ObservationalCohortDepressionUKMissionBipolarTRDDifficult-to-treatTreatment resistant depressionBipolar depressioncohort studyObservational study

Outcome Measures

Primary Outcomes (1)

  • PHQ-9

    Patient Health Questionnaire - 9-item Depression scale. Scores range between 0-27, with higher scores indicating worse depression.

    Up to 36 months.

Other Outcomes (1)

  • GAD-7

    Up to 36 months.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The current study aims to recruit adults aged 18 and over, currently residing in the UK with a diagnosis of major depressive disorder or bipolar disorder. The study will be advertised on social media and will allow people to self-refer to the study. We will also recruit via GP mail outs.

You may qualify if:

  • Those aged 18 and above
  • Primary clinical diagnosis of MDD or bipolar disorder based on DSM-5/ICD-11 diagnostic criteria
  • Participant is willing and able to give informed consent for participation in the study
  • Possesses sufficient command of the English language required to complete study requirements, as assessed by the study team

You may not qualify if:

  • Inability to complete study activities as assessed by the study team
  • Presentation requires immediate emergency treatment
  • Presentation requires clinical input not available within the research clinic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Facility, Warneford Hospital

Oxford, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

DNA, RNA, serum, plasma and peripheral blood mononuclear cells (PBMC)

MeSH Terms

Conditions

Bipolar DisorderDepressive Disorder, Treatment-ResistantDepression

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersDepressive DisorderBehavioral SymptomsBehavior

Central Study Contacts

Professor Michael Browning

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2025

First Posted

September 24, 2025

Study Start

October 1, 2025

Primary Completion (Estimated)

January 31, 2028

Study Completion (Estimated)

January 31, 2028

Last Updated

October 3, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

Locations