NCT04666662

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,244

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

December 7, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 14, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2024

Completed
Last Updated

June 25, 2024

Status Verified

June 1, 2024

Enrollment Period

3.4 years

First QC Date

December 7, 2020

Last Update Submit

June 24, 2024

Conditions

Keywords

PredictionPrognostic modelRelapse

Outcome Measures

Primary Outcomes (1)

  • 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)

    6-8 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Remitted depressive disorder

You may not qualify if:

  • Co-existing severe mental illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of York

York, United Kingdom

Location

Related Publications (2)

  • 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.

  • Moriarty 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.

MeSH Terms

Conditions

DepressionRecurrence

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Andrew Moriarty, MRes

    University of York

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
NIHR Doctoral Research Fellow

Study Record Dates

First Submitted

December 7, 2020

First Posted

December 14, 2020

Study Start

February 1, 2021

Primary Completion

June 24, 2024

Study Completion

June 24, 2024

Last Updated

June 25, 2024

Record last verified: 2024-06

Locations