Depressive DisorderNCT06369805
EVALUATION OF BLOOD BIOMARKER-BASED DIAGNOSTIC AID IN OUTPATIENTS SUFFERING FROM DEPRESSION
An observational study of Depressive Disorder and Bipolar Disorder, run by Les Toises - Psychiatry and Psychotherapy Center at 1 site in Switzerland.
Trial summary
This is an observational (non-interventional) study, carried out in an outpatient setting, which involves a blood sampling. The primary objective of this study is to confirm the association between the EDIT-B® editing signature and early unipolar or bipolar differentiation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depressive Disorder, Bipolar Disorder, Bipolar Depression
- How many people
- 307 participants
- Where
- 1 siteSwitzerland
- Study dates
- 2 Jun 2021to 17 Nov 2022
- 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: Adult outpatients suffering from depression and/or bipolar disorders
Who may be able to join
- Adult outpatients suffering from depression and/or bipolar disorders who gave their written informed consent to participate in the present study
Who cannot join
- Any patient without capacity of discernment or with harmful use of psychoactive substances
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Les Toises - Psychiatry and Psychotherapy Center
Lausanne, 1005
About this study
Official title: EVALUATION DE L'AIDE AU DIAGNOSTIC PAR BIOMARQUEURS SANGINS CHEZ DES PATIENTS SOUFFRANT DE DEPRESSION SUIVIS EN AMBULATOIRE
This is an observational (non-interventional) study, carried out in an outpatient setting, which involves a blood sampling. The primary objective of this study is to confirm the association between the EDIT-B® editing signature and early unipolar or bipolar differentiation. Results of this research may provide an aid to early diagnosis and guide clinical practice towards individualized treatment.
- Conditions
- Depressive Disorder, Bipolar Disorder, Bipolar Depression
- Being tested
- there is no intervention
- Medical subject headings
- Depressive Disorder, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
there is no interventionOther
there is no intervention
| Study group | Role | What they receive |
|---|---|---|
| one group | Not described Receives: Other: there is no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychiatric symptomatology
self- and hetero-psychiatric scales
Measured: Once
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start2 Jun 2021
- Primary completion17 Nov 2022
- Study completion17 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 307 participants (actual)
Sponsor and investigators
- Lead sponsor
- Les Toises - Psychiatry and Psychotherapy Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06369805
- Sponsor's protocol ID
- 2021-00731
- Status last verified
- Apr 2024
- First submitted
- 12 Apr 2024
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION DE L'AIDE AU DIAGNOSTIC PAR BIOMARQUEURS SANGINS CHEZ DES PATIENTS SOUFFRANT DE DEPRESSION SUIVIS EN AMBULATOIRE
- ClinicalTrials.gov ID
- NCT06369805
- Acronym / sponsor ID
- 2021-00731
- Conditions
- Depressive Disorder, Bipolar Disorder, Bipolar Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 307 participants (actual)
- Lead sponsor
- Les Toises - Psychiatry and Psychotherapy CenterUniversity, hospital or other
- Study start
- 2 Jun 2021 (actual)
- Primary completion
- 17 Nov 2022 (actual)
- Study completion
- 17 Nov 2022 (actual)
- First posted
- 17 Apr 2024 (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.
This is an observational (non-interventional) study, carried out in an outpatient setting, which involves a blood sampling. The primary objective of this study is to confirm the association between the EDIT-B® editing signature and early unipolar or bipolar differentiation. Results of this research may provide an aid to early diagnosis and guide clinical practice towards individualized treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| one group | – | Other: there is no intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult outpatients suffering from depression and/or bipolar disorders
Key inclusion criteria (1 listed)
- Adult outpatients suffering from depression and/or bipolar disorders who gave their written informed consent to participate in the present study
Key exclusion criteria (1 listed)
- Any patient without capacity of discernment or with harmful use of psychoactive substances
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 |
|---|---|---|
| there is no interventionthere is no intervention | Other | one group |
Primary outcome
Psychiatric symptomatology
Time frame: Once
self- and hetero-psychiatric scales
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 17 Apr 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Depressive Disorder and Bipolar Disorder, run by Les Toises - Psychiatry and Psychotherapy Center at 1 site in Switzerland.
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 17 Apr 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 Switzerland. 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?
Psychiatric symptomatology (time frame: Once). 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 17 Apr 2024.