Bipolar DisorderNCT02804867
Spot Depression Study
An observational study of Bipolar Disorder and Depressive Disorder, run by University of Cambridge at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder, Depressive Disorder
- What is being tested?
- Online questionnaire and self-administered blood spot
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2016to Sep 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants recruited using flyers, emails, and online recruitment.
Who may be able to join
- Residing in the United Kingdom
- Over 18 years of age
Who cannot join
- Pregnant or breastfeeding
- Presence of blood-borne infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Blood Test to Identify Persons at Risk of Developing Depression or Bipolar Disorder
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.
Read the detailed description
Bipolar disorder and major depression are serious mental health conditions that have a devastating impact on patients, their families and friends, and society. Currently, no laboratory test exists for these disorders. We are trying to develop a molecular test based on blood spots (small spots of blood obtained from patients' fingertips that have been dried on special paper). Volunteers take part by filling out the questionnaire at www.spot-depression.org. They may then be selected to provide a dried blood spot, which can be collected at home using a kit that will be mailed to their address.
- Conditions
- Bipolar Disorder, Depressive Disorder
- Being tested
- Online questionnaire and self-administered blood spot
- Medical subject headings
- Bipolar Disorder, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online questionnaire and self-administered blood spotProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Depression | Not described Receives: Procedure: Online questionnaire and self-administered blood spot | |
| Bipolar disorder | Not described Receives: Procedure: Online questionnaire and self-administered blood spot | |
| Control | Not described Receives: Procedure: Online questionnaire and self-administered blood spot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of protein concentrations in dried blood spots between patient groups and controls
Measured: Baseline (at enrollment); no follow-up
Assessment of classification accuracy of protein concentrations in dried blood spots for distinguishing between bipolar disorder and depression
Measured: Baseline (at enrollment); no follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study startMar 2016
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cambridge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jordan Ramsey, University of Cambridge
- Investigators
- Sabine Bahn, MD/PhD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02804867
- Sponsor's protocol ID
- HBREC.2015.06
- Status last verified
- Feb 2017
- First submitted
- 7 Jun 2016
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Blood Test to Identify Persons at Risk of Developing Depression or Bipolar Disorder
- ClinicalTrials.gov ID
- NCT02804867
- Acronym / sponsor ID
- HBREC.2015.06
- Conditions
- Bipolar Disorder, Depressive Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of CambridgeUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 17 Jun 2016 (estimated)
- 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.
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.
Detailed description
Bipolar disorder and major depression are serious mental health conditions that have a devastating impact on patients, their families and friends, and society. Currently, no laboratory test exists for these disorders. We are trying to develop a molecular test based on blood spots (small spots of blood obtained from patients' fingertips that have been dried on special paper). Volunteers take part by filling out the questionnaire at www.spot-depression.org. They may then be selected to provide a dried blood spot, which can be collected at home using a kit that will be mailed to their address.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants recruited using flyers, emails, and online recruitment.
Key inclusion criteria (2 listed)
- Residing in the United Kingdom
- Over 18 years of age
Key exclusion criteria (2 listed)
- Pregnant or breastfeeding
- Presence of blood-borne infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online questionnaire and self-administered blood spot | Procedure or surgery | Bipolar disorder, Control, Depression |
Primary outcome
Comparison of protein concentrations in dried blood spots between patient groups and controls
Time frame: Baseline (at enrollment); no follow-up
Assessment of classification accuracy of protein concentrations in dried blood spots for distinguishing between bipolar disorder and depression
Time frame: Baseline (at enrollment); no follow-up
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 23 Feb 2017.
- Individual participant dataSharing planned: No
Related trials for Bipolar Disorder
Active, not recruiting
Functional Remediation for Older Adults With Bipolar Disorder
Bipolar Disorder
Recruiting
HD-tDCS for Adolescent Bipolar Depression Targeting S1
Adolescent, Bipolar Depression
Enrolling by invitationObservational study
Digital Phenotypes for Predicting Depression_Validation
Major Depressive Disorder, Bipolar I Disorder
RecruitingPhase 3
A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)
Bipolar Disorder Type I With Mania
RecruitingPhase 2
NMDA Receptor Modulation for the Treatment of Bipolar I Disorder
Bipolar I Disorder
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.
Sabine Bahn, MD/PhD principal investigator
Principal Investigator
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 Bipolar Disorder and Depressive Disorder, run by University of Cambridge 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 2 inclusion and 2 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 23 Feb 2017. 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?
Comparison of protein concentrations in dried blood spots between patient groups and controls (time frame: Baseline (at enrollment); no follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2017; AzTrials last refreshed its copy on 28 Oct 2026.