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New treatment option for Bipolar Disorder
Official title Evaluation of the Impact of the EDIT-B® Blood Test on the Health Status of Patients Presenting a Major Depressive Episode. Clinical Utility and Medico-Economic Aspects
ClinicalTrials.gov ID: NCT06507787
What this study is testing
- What it's testing
- Depression is one of the most common mental disorders, affecting nearly 10% of men and 20% of women worldwide. It is associated with a significant increase in mortality, mainly due to suicidal behavior.
- Time commitment: about 6 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Patients with a MDE, moderate to severe (DSM V criteria and MADRS score ≥19)
- Age between 18 and 65 years, gender indifferent
- Benefitting from health insurance coverage
- Having signed an informed consent and agreed to follow the study protocol to completion
- Patients for whom there is doubt regarding a bipolar disorder diagnosis, and/or presenting one or more of the following criteria:
You likely can't join if
- Depression in the context of schizophrenia or autism spectrum disorder
- Patient with a well-established diagnosis of bipolar disorder
- Patients who is already receiving a mood stabilizer
- Severe somatic diseases that may interfere with the follow-up or associated with treatments at risk of secondary manic decompensation
- Neurodegenerative diseases
- Pregnant women
See the full eligibility criteria
- Patients with a MDE, moderate to severe (DSM V criteria and MADRS score ≥19)
- Age between 18 and 65 years, gender indifferent
- Benefitting from health insurance coverage
- Having signed an informed consent and agreed to follow the study protocol to completion
- Patients for whom there is doubt regarding a bipolar disorder diagnosis, and/or presenting one or more of the following criteria:
- More than 3 episodes of MDE in personal medical history
- Psychotic symptoms
- Family history of bipolar disorder
- Onset of the first MDE before the age of 25
- Atypical symptoms or mixed features during depressive episodes
- Addiction
- Personal history of suicide attempts
- Resistance to antidepressants
- Postpartum depression within 6 months of birth
- Depression in the context of schizophrenia or autism spectrum disorder
- Patient with a well-established diagnosis of bipolar disorder
- Patients who is already receiving a mood stabilizer
- Severe somatic diseases that may interfere with the follow-up or associated with treatments at risk of secondary manic decompensation
- Neurodegenerative diseases
- Pregnant women
The study team makes the final eligibility decision.
Where it's taking place
- Erstein, France
- Issy-les-Moulineaux, France
- La Roche-sur-Foron, France
- Lyon, France
- Montrond-les-Bains, France
- Paris, France
- Ville-d'Avray, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Erstein, France; Issy-les-Moulineaux, France; La Roche-sur-Foron, France; Lyon, France; Montrond-les-Bains, France; Paris, France and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.