A Prognostic Model to PREDICT Relapse of Depression in Primary Care (PREDICTR)

February 2, 2021 updated by: Andrew Moriarty, University of York

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.

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

722

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • Remitted depressive disorder

Exclusion Criteria:

  • Co-existing severe mental illness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
6-8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of York

Collaborators

National Institute for Health Research, United Kingdom
Keele University

Investigators

  • Principal Investigator: Andrew Moriarty, MRes, University of York

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2021

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

December 7, 2020

First Submitted That Met QC Criteria

December 7, 2020

First Posted (Actual)

December 14, 2020

Study Record Updates

Last Update Posted (Actual)

February 3, 2021

Last Update Submitted That Met QC Criteria

February 2, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11ST2044

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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