Validation of a Composite Medical Device Using a Blood Biomarker-based Algorithm and MDQ for the Diagnosis of Bipolar Disorder

NCT07031817 | Recruiting DMC

• 1 other identifier: RECHMPL22_0553
• Study Type: interventional
• Target: 623
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this interventional clinical trial is to assess the diagnostic performance of a composite diagnostic medical devise based on blood-based in vitro diagnostic device and Mood Disorder Questionnaire (MDQ) in identifying bipolar disorder among adult patients presenting with a current major depressive episode in primary care. The study will compare the results of the medical device diagnostic test to those of standardized psychiatric clinical evaluation, to evaluate its sensitivity, specificity, and overall clinical utility. The main research questions are :

• Can the investigational medical device accurately distinguish bipolar disorder from unipolar depression ?
• How does its diagnostic accuracy compare with validated psychiatric questionnaires commonly used in clinical practice ? Participants will :
• Provide a blood sample for biomarker analysis using the investigational diagnostic device.
• Complete a few validated psychiatric assessment tools (e.g., MDQ, MINI).
• Share sociodemographic and clinical data relevant to psychiatric evaluation.

Conditions

Bipolar Disorder (BD); Major Depressive Episode (MDE); Primary Care; Major Depression

Keywords

bipolar disorder; major depressive episode; primary care; composite medical device; blood biomarkers; mood depression questionnaire; diagnosis; composite diagnostic tool; in vitro diagnostic test; blood biomarker-based algorithm

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity of the composite medical device, using the full clinical evaluation as a reference

  To assess the sensitivity and specificity of a composite diagnostic device using a biomarker-based algorithm (IL-6, IL-10, IL-15, IL-27, CXCL10), combined with clinical data (age, depression severity via QIDS, psychotropic treatment), to identify bipolar disorder in primary care patients with a depressive episode. The algorithm, developed by the investigators, will be implemented in the eCRF and classify patients as bipolar, non-bipolar, or in a grey zone. The reference diagnosis will be established by an expert psychiatrist using the MINI interview and a full clinical evaluation, including medical history and patient records, following standardized procedures for optimal diagnostic accuracy.

  Through study completion, an 8 weeks follow-up for each patient

Secondary Outcomes (32)

• Area under the curve

  Through study completion, an 8 weeks follow-up for each patient

• Negative predictive value

  Through study completion, an 8 weeks follow-up for each patient

• Positive predictive value

  Through study completion, an 8 weeks follow-up for each patient

• Occurence of hypomanic symptoms

  From inclusion to the last visit at 7/9 weeks later

• Improvement in depression according to the MADRS scale

  From inclusion to the last visit at 7/9 weeks later

Study Arms (1)

Diagnostic Evaluation Arm

EXPERIMENTAL

Participants in this arm will undergo the full diagnostic procedure under investigation. This includes : * A blood sample collected for analysis by the investigational in vitro diagnostic device targeting biomarkers associated with bipolar disorder, * Completion of validated psychiatric questionnaires, including the Mood Disorder Questionnaire (MDQ), used as clinical reference standards, * Collection of sociodemographic and clinical data relevant to the psychiatric profile. This arm does not involve any therapeutic intervention. The objective is to evaluate the diagnostic concordance between the blood test and psychiatric screening tools.

Diagnostic Test: Venous blood sample for measuring blood biomarkers related to bipolar disorder; Other: Standardized psychiatric assessment tools

Interventions

Venous blood sample for measuring blood biomarkers related to bipolar disorder DIAGNOSTIC_TEST

Participants will undergo a venous blood draw for analysis by an investigational composite medical device designed to aid in the diagnosis of bipolar disorder. The device analyzes specific circulating biomarkers hypothesized to differ between patients with bipolar disorder and those with unipolar depression.

Diagnostic Evaluation Arm

Standardized psychiatric assessment tools OTHER

Participants will complete validated psychiatric screening tools used as reference standards to evaluate bipolar disorder, including the Mood Disorder Questionnaire (MDQ). These tools will be used to compare their diagnostic output with that of the investigational blood test.

Diagnostic Evaluation Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cis man, cis woman, trans man, trans woman or non-binary,
• Aged 18 to 65 years old,
• Meets the DSM-5 criteria for the diagnosis of moderate to severe EDC and is eligible for antidepressant treatment.
• Patients under guardianship or trusteeship,
• Patients with schizophrenia according to DSM-5 criteria,
• Patients with an unstable physiological state or a serious and symptomatic medical condition in the opinion of the investigator,
• Pregnant or breast-feeding patients,
• Patients with a known autoimmune disease, in particular Crohn's disease or thyroiditis, or any other pathology which could, in the opinion of the investigator, modify the blood concentration of immune biomarkers,
• Patients unable to give informed consent to participate in the study or who cannot be given informed information,
• Patients not covered by a social security scheme,
• Patients under court protection,
• Patients vaccinated less than 30 days ago,
• Patients with difficulties reading, understanding or speaking French.

You may not qualify if:

• Participants will have the right to withdraw their consent at any time for any reason whatsoever without any prejudice to them,
• Diagnosis of schizophrenia during follow-up or any other diagnosis that would lead to a change in the initial EDC diagnosis,
• Any condition or situation which, in the opinion of the investigator, would be incompatible with the continuation of the study or which would lead to a bias in the management of the data.

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• CH Béziers: collaborator
• Centre Hospitalier Universitaire de Nīmes: collaborator
• Assistance Publique Hopitaux De Marseille: collaborator
• University Hospital, Toulouse: collaborator
• Nantes University Hospital: collaborator
• USSAP Carcassonne: collaborator
• Ajaccio Hospital Center: collaborator
• CH TOULON: collaborator
• CH Thuir: collaborator
• CH Montauban: collaborator
• Centre de Ressources Biologiques de Montpellier: collaborator
• Federation Regionale de Recherche en Psychiatrie et Sante Mentale Occitanie: collaborator

Study Sites (1)

CHU de Montpellier

Montpellier, 34090, France

RECRUITING

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MeSH Terms

Conditions

Bipolar Disorder; Depressive Disorder, Major; Disease

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Depressive Disorder; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Raoul BELZEAUX

CONTACT

+33 0467337913; raoul.belzeaux@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: June 22, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: October 7, 2025

Record last verified: 2025-10

Locations

FR (1)