DepressionPREDICTRNCT04666662
A Prognostic Model to PREDICT Relapse of Depression in Primary Care
An observational study of Depression, run by University of York at 1 site in United Kingdom.
Trial summary
The investigators aim to develop a prognostic model to predict the risk of relapse within 6-8 months of patients entering remission. The long-term objective is to facilitate more efficient targeting of evidence-based relapse prevention strategies to these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- How many people
- 1,244 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2021to 24 Jun 2024
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will represent an undifferentiated primary care case-mix of patients with depression, meeting clinical criteria for remission at the point of prediction.
Who may be able to join
- Remitted depressive disorder
Who cannot join
- Co-existing severe mental illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Validation of a Prognostic Model to PREDICT Relapse of Depression in Adult Patients in Primary Care
The investigators aim to develop a prognostic model to predict the risk of relapse within 6-8 months of patients entering remission. The long-term objective is to facilitate more efficient targeting of evidence-based relapse prevention strategies to these patients.
Read the detailed description
Most patients with depression are treated in primary care by general practitioners (GPs). Relapse of depression is common and leads to considerable morbidity and decreased quality of life for patients. Estimates suggest that at least 50% of patients treated for depression will relapse after a single episode. The majority of these will relapse within 6 months and the risk of relapse increases for each successive episode of depression. GPs see a largely undifferentiated case-mix of patients and, once patients with depression reach remission, there is limited guidance and no validated tools to help GPs stratify patients according to risk of relapse.This study will potentially derive a statistical model to predict relapse of depression in remitted depressed patients in primary care.
The investigators have created a longitudinal cohort of patients drawn from seven randomised controlled trials (RCTs) of non-pharmacological primary care-based interventions for depression and one longitudinal cohort study. The investigators will use logistic regression to predict the outcome of relapse of depression within 6-8 months. The investigators plan to include the following well-evidenced relapse predictors in the model: residual depressive symptoms; number of previous episodes of depression; co-morbid anxiety; and severity of the index episode. They will also control for RCT intervention received by participants.
If sample size and availability of predictor information allows, the investigators will include the following predictors in an exploratory analysis: age; relationship status; multi-morbidity; employment status; gender; and ethnicity. Generalisability will be assessed through internal-external cross-validation and net benefit will be explored.
- Conditions
- Depression
- Keywords
- Prediction, Prognostic model, Relapse
- Medical subject headings
- Depression, Recurrence
What is being measured
The primary outcome is the main question the study is designed to answer.
Whether a participant relapses or not within 6-8 months (binary outcome)
Relapse is the re-emergence of depressive symptoms according to Patient Health Questionnaire (PHQ-9)
Measured: 6-8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start1 Feb 2021
- Primary completion24 Jun 2024
- Study completion24 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,244 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of York
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Keele University
- Responsible party
- Principal investigator, Andrew Moriarty, University of York
- Investigators
- Andrew Moriarty, MRes, Principal investigator, University of York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04666662
- Sponsor's protocol ID
- 11ST2044
- Acronym
- PREDICTR
- Status last verified
- Jun 2024
- First submitted
- 7 Dec 2020
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Moriarty AS, Paton LW, Snell KIE, Archer L, Riley RD, Buckman JEJ, Chew Graham CA, Gilbody S, Ali S, Pilling S, Meader N, Phillips B, Coventry PA, Delgadillo J, Richards DA, Salisbury C, McMillan D. Development and validation of a prognostic model to predict relapse in adults with remitted depression in primary care: secondary analysis of pooled individual participant data from multiple studies. BMJ Ment Health. 2024 Oct 28;27(1):e301226. doi: 10.1136/bmjment-2024-301226.
PubMed 39467616Moriarty AS, Paton LW, Snell KIE, Riley RD, Buckman JEJ, Gilbody S, Chew-Graham CA, Ali S, Pilling S, Meader N, Phillips B, Coventry PA, Delgadillo J, Richards DA, Salisbury C, McMillan D. The development and validation of a prognostic model to PREDICT Relapse of depression in adult patients in primary care: protocol for the PREDICTR study. Diagn Progn Res. 2021 Jul 2;5(1):12. doi: 10.1186/s41512-021-00101-x.
PubMed 34215317
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Prognostic Model to PREDICT Relapse of Depression in Adult Patients in Primary Care
- ClinicalTrials.gov ID
- NCT04666662
- Acronym / sponsor ID
- PREDICTR / 11ST2044
- Conditions
- Depression
- Keywords
- Prediction, Prognostic model, Relapse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,244 participants (actual)
- Lead sponsor
- University of YorkUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Keele University
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 24 Jun 2024 (actual)
- Study completion
- 24 Jun 2024 (actual)
- First posted
- 14 Dec 2020 (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 investigators aim to develop a prognostic model to predict the risk of relapse within 6-8 months of patients entering remission. The long-term objective is to facilitate more efficient targeting of evidence-based relapse prevention strategies to these patients.
Detailed description
Most patients with depression are treated in primary care by general practitioners (GPs). Relapse of depression is common and leads to considerable morbidity and decreased quality of life for patients. Estimates suggest that at least 50% of patients treated for depression will relapse after a single episode. The majority of these will relapse within 6 months and the risk of relapse increases for each successive episode of depression. GPs see a largely undifferentiated case-mix of patients and, once patients with depression reach remission, there is limited guidance and no validated tools to help GPs stratify patients according to risk of relapse.This study will potentially derive a statistical model to predict relapse of depression in remitted depressed patients in primary care.
The investigators have created a longitudinal cohort of patients drawn from seven randomised controlled trials (RCTs) of non-pharmacological primary care-based interventions for depression and one longitudinal cohort study. The investigators will use logistic regression to predict the outcome of relapse of depression within 6-8 months. The investigators plan to include the following well-evidenced relapse predictors in the model: residual depressive symptoms; number of previous episodes of depression; co-morbid anxiety; and severity of the index episode. They will also control for RCT intervention received by participants.
If sample size and availability of predictor information allows, the investigators will include the following predictors in an exploratory analysis: age; relationship status; multi-morbidity; employment status; gender; and ethnicity. Generalisability will be assessed through internal-external cross-validation and net benefit will be explored.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will represent an undifferentiated primary care case-mix of patients with depression, meeting clinical criteria for remission at the point of prediction.
Key inclusion criteria (1 listed)
- Remitted depressive disorder
Key exclusion criteria (1 listed)
- Co-existing severe mental illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Whether a participant relapses or not within 6-8 months (binary outcome)
Time frame: 6-8 months
Relapse is the re-emergence of depressive symptoms according to Patient Health Questionnaire (PHQ-9)
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 25 Jun 2024.
- Derived from this study: PubMed 39467616Moriarty AS, Paton LW, Snell KIE, Archer L, Riley RD, Buckman JEJ, Chew Graham CA, Gilbody S, Ali S, Pilling S, Meader N, Phillips B, Coventry PA, Delgadillo J, Richards DA, Salisbury C, McMillan D. Development and validation of a prognostic model to predict relapse in adults with remitted depression in primary care: secondary analysis of pooled individual participant data from multiple studies. BMJ Ment Health. 2024 Oct 28;27(1):e301226. doi: 10.1136/bmjment-2024-301226.
- Derived from this study: PubMed 34215317Moriarty AS, Paton LW, Snell KIE, Riley RD, Buckman JEJ, Gilbody S, Chew-Graham CA, Ali S, Pilling S, Meader N, Phillips B, Coventry PA, Delgadillo J, Richards DA, Salisbury C, McMillan D. The development and validation of a prognostic model to PREDICT Relapse of depression in adult patients in primary care: protocol for the PREDICTR study. Diagn Progn Res. 2021 Jul 2;5(1):12. doi: 10.1186/s41512-021-00101-x.
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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.
Andrew Moriarty, MRes principal investigator
University of York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, run by University of York 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 1 inclusion and 1 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 25 Jun 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?
Whether a participant relapses or not within 6-8 months (binary outcome) (time frame: 6-8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04666662, which also lists 2 linked publications.
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 25 Jun 2024.