NCT02804867

Brief Summary

This study aims to identify signs of depression and bipolar disorder by measuring changes of certain molecules (biomarkers) that can be detected in dried blood spots. Our goal is to use these biomarkers to develop a diagnostic test to enable early treatment, which can lead to better patient outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2016

Shorter than P25 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

Study Start

First participant enrolled

March 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 17, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

6 months

First QC Date

June 7, 2016

Last Update Submit

February 19, 2017

Conditions

Bipolar DisorderDepressive Disorder

Outcome Measures

Primary Outcomes (2)

  • Comparison of protein concentrations in dried blood spots between patient groups and controls

    Baseline (at enrollment); no follow-up

  • Assessment of classification accuracy of protein concentrations in dried blood spots for distinguishing between bipolar disorder and depression

    Baseline (at enrollment); no follow-up

Study Arms (3)

Depression

Procedure: Online questionnaire and self-administered blood spot

Bipolar disorder

Procedure: Online questionnaire and self-administered blood spot

Control

Procedure: Online questionnaire and self-administered blood spot

Interventions

Online questionnaire and self-administered blood spotPROCEDURE
Bipolar disorderControlDepression

Eligibility Criteria

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

Participants recruited using flyers, emails, and online recruitment.

You may qualify if:

  • Residing in the United Kingdom
  • Over 18 years of age

You may not qualify if:

  • Pregnant or breastfeeding
  • Presence of blood-borne infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jordan Ramsey

Cambridge, Cambridgeshire, CB2 1QT, United Kingdom

Location

MeSH Terms

Conditions

Bipolar DisorderDepressive Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Study Officials

  • Sabine Bahn, MD/PhD

    Principal Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoctoral researcher

Study Record Dates

First Submitted

June 7, 2016

First Posted

June 17, 2016

Study Start

March 1, 2016

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

February 23, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)