SchizophreniaBIO-INMNCT07741981
Treatment Resistance in Psychiatric Disorders: the Search for Biological Markers Predictive of Response to Treatment
A study testing Blood sampling, lumbar puncture, stool sampling, skin microbiopsy and psychometrics scales in people with Schizophrenia and Treatment Resistant Depression (TRD), run by Centre Hospitalier St Anne at 1 site in France.
Trial summary
The disruption of immune system is a key candidate in the pathogenesis of psychiatric disorders, especially those resistant to traditional treatments. Involving complex processes within the brain and peripheral immune system, inflammation may lead to imbalance of neurotransmitter systems and synaptic plasticity and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Treatment Resistant Depression (TRD), Bipolar Disorder (BD)
- What is being tested?
- Blood sampling, lumbar puncture, stool sampling, skin microbiopsy and psychometrics scales
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteFrance
- Study dates
- 20 Aug 2026to 1 Sep 2038
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Patient aged ≥ 18 years old;
- Patient suffering from a psychiatric disorder according to DSM-5 criteria;
- Patient with drug-resistant disease according to the definition of the protocol
- Patient starting a new treatment for his pathology;
- Patient informed and having signed an informed consent;
- Patient covered by the social security system.
Who cannot join
- Patient with major neurocognitive disorder diagnosed (dementia syndrome)
- Pregnant, laboring, or breastfeeding female patients
- Patient deprived of liberty by judicial or administrative decision. Patient in psychiatric care under constraints may be included.
- For patients accepting the lumbar punction: patients who are unable to control themselves and are likely to engage in physical or violent behavior.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
GHU Paris - Psychiatrie et Neurosciences
Paris, 75014
Cécile MICHEL, +331 80 52 70 19, cecile.bultez@ghu-paris.fr
About this study
The disruption of immune system is a key candidate in the pathogenesis of psychiatric disorders, especially those resistant to traditional treatments. Involving complex processes within the brain and peripheral immune system, inflammation may lead to imbalance of neurotransmitter systems and synaptic plasticity and directly contribute to the psychiatric symptoms observed in conditions such as depression, bipolar disorder (BD) and schizophrenia (SCZ).
Studies show that treatment-resistant depression (TRD) is associated with elevated levels of inflammatory markers in the blood, which are linked to a lower response to conventional antidepressants. Interventions that modulate this inflammatory response, such as immunomodulatory treatments or therapies targeting pro-inflammatory cytokines, have demonstrated beneficial effects by reducing symptoms and improving patients' quality of life.
A thorough understanding of the links between inflammation and treatment resistance therefore paves the way for innovative therapeutic strategies. These approaches could transform current practices by offering more personalized and effective solutions for patients suffering from chronic and resistant psychiatric disorders.
- Conditions
- Schizophrenia, Treatment Resistant Depression (TRD), Bipolar Disorder (BD), Catatonia, Obsessive Compulsive Disorder (OCD)
- Being tested
- Blood sampling, lumbar puncture, stool sampling, skin microbiopsy and psychometrics scales
- Keywords
- biomarkers, treatment resistance, response prediction
- Medical subject headings
- Schizophrenia, Depressive Disorder, Treatment-Resistant, Bipolar Disorder, Catatonia, Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampling, lumbar puncture, stool sampling, skin microbiopsy and psychometrics scalesBiological
the biomarker research involves different biological sampling : blood, stool, cerebrospinal fluid, skin
| Study group | Role | What they receive |
|---|---|---|
| OCD cohort | Other | Patients suffering from OCD resistant to treatments Receives: Biological: Blood sampling, lumbar puncture, stool sampling, skin microbiopsy and psychometrics scales |
| Catatonia cohort | Other | Patients suffering from resistant catatonia Receives: Biological: Blood sampling, lumbar puncture, stool sampling, skin microbiopsy and psychometrics scales |
| TRD cohort | Other | Patients suffering from treatment resistant depression (TRD) Receives: Biological: Blood sampling, lumbar puncture, stool sampling, skin microbiopsy and psychometrics scales |
| BD cohort | Other | Patients suffering from treatment resistant bipolar disorders (BD) Receives: Biological: Blood sampling, lumbar puncture, stool sampling, skin microbiopsy and psychometrics scales |
| Schizophrenia cohort | Other | Patients suffering from schizophrenia resistant to treatments Receives: Biological: Blood sampling, lumbar puncture, stool sampling, skin microbiopsy and psychometrics scales |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from inclusion (V1) in disease scale scores at the end of acute phase therapy (V3)
Changes in Positive and Negative Syndrome Scale (PANSS) scores between inclusion (V1) and the end of acute phase therapy (V3). The scale will be used to assess disease severity for Schizophrenia patients. The minimal score is 30. The maximal score is 210.
Measured: Up to 10 weeks
Changes from inclusion (V1) in disease scale scores at the end of acute phase therapy (V3)
Changes in Montgomery-Åsberg Depression Rating Scale (MADRS) scores between inclusion (V1) and the end of acute phase therapy (V3). The scale will be used to assess disease severity for depression. The minimal score is 0. The maximal score is 60.
Measured: Up to 10 weeks
Changes from inclusion (V1) in disease scale scores at the end of acute phase therapy (V3)
Changes in Young Mania Rating Scale (YMRS) scores between inclusion (V1) and the end of acute phase therapy (V3). The scale will be used to assess disease severity for bipolar troubles. The minimal score is 0. The maximal score is 60.
Measured: Up to 10 weeks
Changes from inclusion (V1) in disease scale scores at the end of acute phase therapy (V3)
Changes in Obsessive-Compulsive Inventory-Revised (OCI-R) scores between inclusion (V1) and the end of acute phase therapy (V3). The scale will be used to assess disease severity for obsessive compulsive disorder. The minimal score is 0. The maximal score is 72.
Measured: Up to 10 weeks
Changes from inclusion (V1) in disease scale scores at the end of acute phase therapy (V3)
Changes in Visual analogic scale for obsessive compulsive disorder (VAS-OCD) scores between inclusion (V1) and the end of acute phase therapy (V3). The scale will be used to assess disease severity for obsessive compulsive disorder. The minimal score is 0 mm. The maximal score is 100 mm.
Measured: Up to 10 weeks
Changes from inclusion (V1) in disease scale scores at the end of acute phase therapy (V3)
Changes in Bush-Francis Catatonia Rating Scale (BFCRS) scores between inclusion (V1) and the end of acute phase therapy (V3). The scale will be used to assess disease severity for catatonia. The minimal score is 0 mm. The maximal score is 69.
Measured: Up to 10 weeks
Changes from inclusion (V1) in biological parameters at the end of acute phase therapy (V3).
Changes in biological parameters measured between inclusion (V1) and the end of acute phase therapy (V3). The dosages are : White blood cells, neutrophils, eosinophils, basophils, lymphocytes, monocytes, platelets in G/L
Measured: Up to 10 weeks
Changes from inclusion (V1) in biological parameters at the end of acute phase therapy (V3).
Changes in biological parameters measured between inclusion (V1) and the end of acute phase therapy (V3). The dosages are : C3, C4, fibrinogen in g/L.
Measured: Up to 10 weeks
Changes from inclusion (V1) in biological parameters at the end of acute phase therapy (V3).
Changes in biological parameters measured between inclusion (V1) and the end of acute phase therapy (V3). The dosages are : Vitamin B12, IL-1β, IL-6, IL-18 in pg/mL.
Measured: Up to 10 weeks
Changes from inclusion (V1) in biological parameters at the end of acute phase therapy (V3).
Changes in biological parameters measured between inclusion (V1) and the end of acute phase therapy (V3). The dosages are : Folate, Vitamin B1, B6, D, cortisol in nmol/L.
Measured: Up to 10 weeks
Changes from inclusion (V1) in biological parameters at the end of acute phase therapy (V3).
Changes in biological parameters measured between inclusion (V1) and the end of acute phase therapy (V3). The dosages are : TSH, prolactin in mUI/L
Measured: Up to 10 weeks
Changes from inclusion (V1) in biological parameters at the end of acute phase therapy (V3).
Changes in biological parameters measured between inclusion (V1) and the end of acute phase therapy (V3). The dosages are : CRPus, β2 microglobulin, C1q in mg/L.
Measured: Up to 10 weeks
Changes from inclusion (V1) in biological parameters at the end of acute phase therapy (V3).
Changes in biological parameters measured between inclusion (V1) and the end of acute phase therapy (V3). The dosages are : anti-TPO Ab, anti-TG Ab, CH50 in UI/mL.
Measured: Up to 10 weeks
Secondary outcomes (34)
Changes in CRPus from inclusion (V1) to Day 2 (V2)
Variation in CRPus between inclusion (V1) and Day 2 (V2) in mg/L.
Measured: From enrollment to Day 2
Changes in immunity markers from inclusion (V1) to Day 2 (V2)
Variation in IL-1β, IL-6, and IL-18 between inclusion (V1) and Day 2 (V2) in pg/mL.
Measured: From enrollment to Day 2
Changes from inclusion (V1) in standardized clinical disease scale scores at Day 2 (V2)
Changes in Bush-Francis Catatonia Rating Scale (BFCRS) scores between inclusion (V1) and Day 2 (V2). The scale will be used to assess disease severity for catatonia. The minimal score is 0 mm. The maximal score is 69.
Measured: From enrollment to Day 2
Changes from inclusion (V1) in standardized clinical disease scale scores at Day 2 (V2)
Changes in Positive and Negative Syndrome Scale (PANSS) scores between inclusion (V1) and Day 2 (V2). The scale will be used to assess disease severity for Schizophrenia patients. The minimal score is 30. The maximal score is 210.
Measured: From enrollment to Day 2
Changes from inclusion (V1) in standardized clinical disease scale scores at Day 2 (V2)
Changes in Montgomery-Åsberg Depression Rating Scale (MADRS) scores between inclusion (V1) and day 2 (V2). The scale will be used to assess disease severity for depression. The minimal score is 0. The maximal score is 60.
Measured: From enrollment to Day 2
Changes from inclusion (V1) in standardized clinical disease scale scores at Day 2 (V2)
Changes in Young Mania Rating Scale (YMRS) scores between inclusion (V1) and Day 2 (V2). The scale will be used to assess disease severity for bipolar troubles. The minimal score is 0. The maximal score is 60.
Measured: From enrollment to Day 2
Changes from inclusion (V1) in standardized clinical disease scale scores at Day 2 (V2)
Changes in Visual analogic scale for obsessive compulsive disorder (VAS-OCD) scores between inclusion (V1) and Day 2 (V2). The scale will be used to assess disease severity for obsessive compulsive disorder. The minimal score is 0 mm. The maximal score is 100 mm.
Measured: From enrollment to Day 2
Changes from inclusion (V1) in standardized clinical disease scale scores at Day 2 (V2)
Changes in Obsessive-Compulsive Inventory-Revised (OCI-R) scores between inclusion (V1) and Day 2 (V2). The scale will be used to assess disease severity for obsessive compulsive disorder. The minimal score is 0. The maximal score is 72.
Measured: From enrollment to Day 2
Changes from inclusion (V1) to end of study (M24) in standardized clinical disease scale scores
Changes in Positive and Negative Syndrome Scale (PANSS) scores between inclusion (V1) and the end of study EOS (M24). The scale will be used to assess disease severity for Schizophrenia patients. The minimal score is 30. The maximal score is 210.
Measured: through study completion, an average of 2 years
Changes from inclusion (V1) to end of study (M24) in standardized clinical disease scale scores
Changes in Montgomery-Åsberg Depression Rating Scale (MADRS) scores between inclusion (V1) and the end of study (M24). The scale will be used to assess disease severity for depression. The minimal score is 0. The maximal score is 60.
Measured: through study completion, an average of 2 years
Changes from inclusion (V1) to end of study (M24) in standardized clinical disease scale scores
Variation in standardized clinical disease scale scores between inclusion (V1) and EOS (M24).
Changes in Young Mania Rating Scale (YMRS) scores between inclusion (V1) and the end of study (M24). The scale will be used to assess disease severity for bipolar troubles. The minimal score is 0. The maximal score is 60.
Measured: through study completion, an average of 2 years
Changes from inclusion (V1) to end of study (M24) in standardized clinical disease scale scores
Changes in Obsessive-Compulsive Inventory-Revised (OCI-R) scores between inclusion (V1) and the end of study (M24). The scale will be used to assess disease severity for obsessive compulsive disorder. The minimal score is 0. The maximal score is 72.
Measured: through study completion, an average of 2 years
Changes from inclusion (V1) to end of study (M24) in standardized clinical disease scale scores
Variation in standardized clinical disease scale scores between inclusion (V1) and EOS (M24).
Changes in Visual analogic scale for obsessive compulsive disorder (VAS-OCD) scores between inclusion (V1) and the end of study (M24). The scale will be used to assess disease severity for obsessive compulsive disorder. The minimal score is 0 mm. The maximal score is 100 mm.
Measured: through study completion, an average of 2 years
Changes from inclusion (V1) to end of study (M24) in standardized clinical disease scale scores
Changes in Bush-Francis Catatonia Rating Scale (BFCRS) scores between inclusion (V1) and the end of study (M24). The scale will be used to assess disease severity for catatonia. The minimal score is 0 mm. The maximal score is 69.
Measured: through study completion, an average of 2 years
Changes from inclusion (V1) to end of study (M24) in CBC components
Variation in Complete Blood Count components between inclusion (V1) and End Of Study (M24) : White blood cells, neutrophils, eosinophils, basophils, lymphocytes, monocytes, platelets in G/L.
Measured: through study completion, an average of 2 years
Changes from inclusion (V1) to end of study (M24) in Folates, Vitamin B6, Vitamin B1, Vitamin D
Changes in biological parameters measured between inclusion (V1) and the End Of Study (M24). The dosages are : Folates, Vitamins B1, B6, D in nmol/L.
Measured: through study completion, an average of 2 years
Changes from inclusion (V1) to end of study (M24) in Vitamin B12
Changes in Vitamin B12 measured between inclusion (V1) and the End Of Study (M24) in pg/mL.
Measured: through study completion, an average of 2 years
Changes from inclusion (V1) to end of study (M24) in TSH, prolactin
Changes in biological parameters measured between inclusion (V1) and End Of Study (M24). The dosages are : TSH, prolactin in mUI/L
Measured: through study completion, an average of 2 years
Changes from inclusion (V1) to end of study (M24) in drug dosage
Variation in drug dosage between inclusion (V1) and End Of Study (M24). Unit could be different according to the drug.
Measured: through study completion, an average of 2 years
Changes from inclusion in levels of pro-inflammatory cytokines and other immune biomarkers in cerebrospinal fluid, skin biopsies and/or stool, at end of acute treatment (V3), 6-month follow-up (V4), 12-month follow-up (V5) and 24-month follow-up (V6)
Change in levels of pro-inflammatory cytokines and other immune biomarkers in other biological samples (cerebrospinal fluid (CSF), skin biopsies, stool) between inclusion (V1) , end of acute treatment (V3), 6-month follow-up (V4), 12-month follow-up (V5) and 24-month follow-up (V6). This will enable direct assessment of the efficacy of interventions on immune processes.
Measured: At inclusion (V1), 10 weeks, 6 months-, 12 months- and 24 months after end of acute treatment
Changes from inclusion (V1) in functional (Clinical Global Impression, CGI-S and CGI-I) scores to end of acute treatment (V3)
Variation in Clinical Global Impression (CGI-S and CGI-I) questionnaire scores between inclusion (V1) and end of acute treatment (V3):
- CGI-Severity (CGI-S) assess global disease severity. The Score min is 1 and Score max is 7.
- CGI-Improvement (CGI-I) : assess the improvement or deterioration of the disease compared to initial state. The Score min is 1 (highly improved). The Score max is 7 (Highly deteriorated).
Measured: Up to 10 weeks
Changes from inclusion (V1) in quality of life (by WHOQOL-BREF questionnaire) scores to end of acute treatment (V3)
Variation in WHOQOL-BREF questionnaire scores between inclusion (V1) and end of acute treatment (V3). The minimum score is 16 and the maximum is 80. The higher the score, the better the perceived quality of life in the relevant area.
Measured: Up to 10 weeks
Changes from inclusion in quality of life (by WHOQOL-BREF scores), to End Of Study (M24)
Variation in quality-of-life questionnaire scores (WHOQOL-BREF) between inclusion (V1) and End Of Study (M24). The minimal score is 16 and the maximal is 80. The higher the score, the better the perceived quality of life in the relevant area.
Measured: through study completion, an average of 2 years
Changes from inclusion in functional score (by Clinical Global Impression scale), to End Of Study (M24)
Variation in Clinical Global Impression (CGI-S and CGI-I) questionnaire scores between inclusion (V1) and end of study (M24):
- CGI-Severity (CGI-S) assess global disease severity. The Score min is 1 and Score max is 7.
- CGI-Improvement (CGI-I) : assess the improvement or deterioration of the disease compared to initial state. The Score min is 1 (highly improved). The Score max is 7 (Highly deteriorated).
Measured: through study completion, an average of 2 years
Number of side-effects (type, intensity, severity) in total population and by cohort between study inclusion (V1) and end of study (M24)
Side-effects (type, intensity, severity) in total population and by cohort between study inclusion and End Of Study (M24)
Measured: through study completion, an average of 2 years
Number and characteristics of biomarkers identified in the retrospectively and prospectively included populations
The number and characteristics of biomarkers identified in the retrospectively and prospectively included populations throughout the study
Measured: through study completion, an average of 2 years
Changes from inclusion (V1) in fibrinogen, C3, C4 to End Of Study (M24)
Changes in biological parameters measured between inclusion (V1) and the end of study (M24). The dosages are : C3, C4, fibrinogen in g/L.
Measured: through study completion, an average of 2 years
Changes from inclusion (V1) to End Of Study (M24) in IL-1β, IL-6, IL-18
Changes in biological parameters measured between inclusion (V1) and the End Of Study (M24). The dosages are : IL-1β, IL-6, IL-18 in pg/mL.
Measured: through study completion, an average of 2 years
Changes from inclusion (V1) to End Of Study (M24) in cortisol dosage
Changes in cortisol measured between inclusion (V1) and the end of study (M24) in nmol/L.
Measured: through study completion, an average of 2 years
Changes from inclusion (V1) to End Of Study (M24) in CRPus, β2 microglobulin, C1q
Changes in biological parameters measured between inclusion (V1) and End Of Study (M24). The dosages are : CRPus, β2 microglobulin, C1q in mg/L.
Measured: through study completion, an average of 2 years
Changes from inclusion (V1) to End Of Study (M24) in anti-TPO Ab, anti-TG Ab, CH50
Changes in biological parameters measured between inclusion (V1) and the End Of Study (M24). The dosages are : anti-Peroxidase Antibodies, anti-thyroglobulin Antibodies, Hemolytic Complement 50 in UI/mL.
Measured: through study completion, an average of 2 years
Changes from inclusion (V1) to End Of Study (M24) in anti-TRAK Ab
Variation in anti TSH receptor specific Antibodies (anti-TRAK Ab) between inclusion (V1) and End Of Study (M24)
Measured: through study completion, an average of 2 years
Changes from inclusion (V1) to End Of Study (M24) in neuronal Ab
Number of positive neuronal antibodies between inclusion (V1) and End Of Study (M24)
Measured: through study completion, an average of 2 years
Changes from inclusion (V1) to End Of Study (M24) in interferon signature score
Variation in interferon signature score between inclusion (V1) and End Of Study (M24)
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start20 Aug 2026
- Primary completion1 Nov 2036 (estimated)
- Study completion1 Sep 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier St AnneThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Single-center, ambispective, non-randomized, non-controlled study. Exploratory study investigating biomarkers of treatment resistance in adult patients with psychiatric disorders. Patients will be divided into 5 cohorts.
- Masking
- None (open label)
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier St Anne
- Sponsor type
- University, hospital or other
- Collaborators
- GHU Paris Psychiatry & Neurosciences
- Responsible party
- Sponsor
- Investigators
- Anne-Cécile PETIT, MD, PhD, Study director, GHU Paris Psychiatry & Neurosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07741981
- Sponsor's protocol ID
- D25-P041
- Other IDs
- N°ID-RCB: 2026-A00433-48
- Acronym
- BIO-INM
- Status last verified
- Jun 2026
- First submitted
- 29 Jun 2026
- Last updated
- 21 Sep 2026
- 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 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Resistance in Psychiatric Disorders: the Search for Biological Markers Predictive of Response to Treatment
- ClinicalTrials.gov ID
- NCT07741981
- Acronym / sponsor ID
- BIO-INM / D25-P041
- Conditions
- Schizophrenia, Treatment Resistant Depression (TRD), Bipolar Disorder (BD), Catatonia, Obsessive Compulsive Disorder (OCD)
- Keywords
- biomarkers, treatment resistance, response prediction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Centre Hospitalier St AnneUniversity, hospital or other
- Collaborators
- GHU Paris Psychiatry & Neurosciences
- Study start
- 20 Aug 2026 (actual)
- Primary completion
- 1 Nov 2036 (estimated)
- Study completion
- 1 Sep 2038 (estimated)
- First posted
- 3 Aug 2026 (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.
The disruption of immune system is a key candidate in the pathogenesis of psychiatric disorders, especially those resistant to traditional treatments. Involving complex processes within the brain and peripheral immune system, inflammation may lead to imbalance of neurotransmitter systems and synaptic plasticity and directly contribute to the psychiatric symptoms observed in conditions such as depression, bipolar disorder (BD) and schizophrenia (SCZ).
Studies show that treatment-resistant depression (TRD) is associated with elevated levels of inflammatory markers in the blood, which are linked to a lower response to conventional antidepressants. Interventions that modulate this inflammatory response, such as immunomodulatory treatments or therapies targeting pro-inflammatory cytokines, have demonstrated beneficial effects by reducing symptoms and improving patients' quality of life.
A thorough understanding of the links between inflammation and treatment resistance therefore paves the way for innovative therapeutic strategies. These approaches could transform current practices by offering more personalized and effective solutions for patients suffering from chronic and resistant psychiatric disorders.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Single-center, ambispective, non-randomized, non-controlled study. Exploratory study investigating biomarkers of treatment resistance in adult patients with psychiatric disorders. Patients will be divided into 5 cohorts.
| Arm | Type | Receives |
|---|---|---|
| OCD cohort | Other | Biological: Blood sampling, lumbar puncture, stool sampling, skin microbiopsy and psychometrics scalesPatients suffering from OCD resistant to treatments |
| Catatonia cohort | Other | Biological: Blood sampling, lumbar puncture, stool sampling, skin microbiopsy and psychometrics scalesPatients suffering from resistant catatonia |
| TRD cohort | Other | Biological: Blood sampling, lumbar puncture, stool sampling, skin microbiopsy and psychometrics scalesPatients suffering from treatment resistant depression (TRD) |
| BD cohort | Other | Biological: Blood sampling, lumbar puncture, stool sampling, skin microbiopsy and psychometrics scalesPatients suffering from treatment resistant bipolar disorders (BD) |
| Schizophrenia cohort | Other | Biological: Blood sampling, lumbar puncture, stool sampling, skin microbiopsy and psychometrics scalesPatients suffering from schizophrenia resistant to treatments |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient aged ≥ 18 years old;
- Patient suffering from a psychiatric disorder according to DSM-5 criteria;
- Patient with drug-resistant disease according to the definition of the protocol
- Patient starting a new treatment for his pathology;
- Patient informed and having signed an informed consent;
Key exclusion criteria (4 listed)
- Patient with major neurocognitive disorder diagnosed (dementia syndrome)
- Pregnant, laboring, or breastfeeding female patients
- Patient deprived of liberty by judicial or administrative decision. Patient in psychiatric care under constraints may be included.
- For patients accepting the lumbar punction: patients who are unable to control themselves and are likely to engage in physical or violent behavior.
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 |
|---|---|---|
| Blood sampling, lumbar puncture, stool sampling, skin microbiopsy and psychometrics scalesthe biomarker research involves different biological sampling : blood, stool, cerebrospinal fluid, skin | Biological | BD cohort, Catatonia cohort, OCD cohort, Schizophrenia cohort, TRD cohort |
Primary outcome
Changes from inclusion (V1) in disease scale scores at the end of acute phase therapy (V3)
Time frame: Up to 10 weeks
Changes in Positive and Negative Syndrome Scale (PANSS) scores between inclusion (V1) and the end of acute phase therapy (V3). The scale will be used to assess disease severity for Schizophrenia patients. The minimal score is 30. The maximal score is 210.
Changes from inclusion (V1) in disease scale scores at the end of acute phase therapy (V3)
Time frame: Up to 10 weeks
Changes in Montgomery-Åsberg Depression Rating Scale (MADRS) scores between inclusion (V1) and the end of acute phase therapy (V3). The scale will be used to assess disease severity for depression. The minimal score is 0. The maximal score is 60.
Changes from inclusion (V1) in disease scale scores at the end of acute phase therapy (V3)
Time frame: Up to 10 weeks
Changes in Young Mania Rating Scale (YMRS) scores between inclusion (V1) and the end of acute phase therapy (V3). The scale will be used to assess disease severity for bipolar troubles. The minimal score is 0. The maximal score is 60.
Changes from inclusion (V1) in disease scale scores at the end of acute phase therapy (V3)
Time frame: Up to 10 weeks
Changes in Obsessive-Compulsive Inventory-Revised (OCI-R) scores between inclusion (V1) and the end of acute phase therapy (V3). The scale will be used to assess disease severity for obsessive compulsive disorder. The minimal score is 0. The maximal score is 72.
Changes from inclusion (V1) in disease scale scores at the end of acute phase therapy (V3)
Time frame: Up to 10 weeks
Changes in Visual analogic scale for obsessive compulsive disorder (VAS-OCD) scores between inclusion (V1) and the end of acute phase therapy (V3). The scale will be used to assess disease severity for obsessive compulsive disorder. The minimal score is 0 mm. The maximal score is 100 mm.
Changes from inclusion (V1) in disease scale scores at the end of acute phase therapy (V3)
Time frame: Up to 10 weeks
Changes in Bush-Francis Catatonia Rating Scale (BFCRS) scores between inclusion (V1) and the end of acute phase therapy (V3). The scale will be used to assess disease severity for catatonia. The minimal score is 0 mm. The maximal score is 69.
Changes from inclusion (V1) in biological parameters at the end of acute phase therapy (V3).
Time frame: Up to 10 weeks
Changes in biological parameters measured between inclusion (V1) and the end of acute phase therapy (V3). The dosages are : White blood cells, neutrophils, eosinophils, basophils, lymphocytes, monocytes, platelets in G/L
Changes from inclusion (V1) in biological parameters at the end of acute phase therapy (V3).
Time frame: Up to 10 weeks
Changes in biological parameters measured between inclusion (V1) and the end of acute phase therapy (V3). The dosages are : C3, C4, fibrinogen in g/L.
Changes from inclusion (V1) in biological parameters at the end of acute phase therapy (V3).
Time frame: Up to 10 weeks
Changes in biological parameters measured between inclusion (V1) and the end of acute phase therapy (V3). The dosages are : Vitamin B12, IL-1β, IL-6, IL-18 in pg/mL.
Changes from inclusion (V1) in biological parameters at the end of acute phase therapy (V3).
Time frame: Up to 10 weeks
Changes in biological parameters measured between inclusion (V1) and the end of acute phase therapy (V3). The dosages are : Folate, Vitamin B1, B6, D, cortisol in nmol/L.
Changes from inclusion (V1) in biological parameters at the end of acute phase therapy (V3).
Time frame: Up to 10 weeks
Changes in biological parameters measured between inclusion (V1) and the end of acute phase therapy (V3). The dosages are : TSH, prolactin in mUI/L
Changes from inclusion (V1) in biological parameters at the end of acute phase therapy (V3).
Time frame: Up to 10 weeks
Changes in biological parameters measured between inclusion (V1) and the end of acute phase therapy (V3). The dosages are : CRPus, β2 microglobulin, C1q in mg/L.
Changes from inclusion (V1) in biological parameters at the end of acute phase therapy (V3).
Time frame: Up to 10 weeks
Changes in biological parameters measured between inclusion (V1) and the end of acute phase therapy (V3). The dosages are : anti-TPO Ab, anti-TG Ab, CH50 in UI/mL.
34 secondary outcomes
Changes in CRPus from inclusion (V1) to Day 2 (V2)
Time frame: From enrollment to Day 2
Changes in immunity markers from inclusion (V1) to Day 2 (V2)
Time frame: From enrollment to Day 2
Changes from inclusion (V1) in standardized clinical disease scale scores at Day 2 (V2)
Time frame: From enrollment to Day 2
Changes from inclusion (V1) in standardized clinical disease scale scores at Day 2 (V2)
Time frame: From enrollment to Day 2
Changes from inclusion (V1) in standardized clinical disease scale scores at Day 2 (V2)
Time frame: From enrollment to Day 2
Changes from inclusion (V1) in standardized clinical disease scale scores at Day 2 (V2)
Time frame: From enrollment to Day 2
Changes from inclusion (V1) in standardized clinical disease scale scores at Day 2 (V2)
Time frame: From enrollment to Day 2
Changes from inclusion (V1) in standardized clinical disease scale scores at Day 2 (V2)
Time frame: From enrollment to Day 2
Changes from inclusion (V1) to end of study (M24) in standardized clinical disease scale scores
Time frame: through study completion, an average of 2 years
Changes from inclusion (V1) to end of study (M24) in standardized clinical disease scale scores
Time frame: through study completion, an average of 2 years
Changes from inclusion (V1) to end of study (M24) in standardized clinical disease scale scores
Time frame: through study completion, an average of 2 years
Changes from inclusion (V1) to end of study (M24) in standardized clinical disease scale scores
Time frame: through study completion, an average of 2 years
Changes from inclusion (V1) to end of study (M24) in standardized clinical disease scale scores
Time frame: through study completion, an average of 2 years
Changes from inclusion (V1) to end of study (M24) in standardized clinical disease scale scores
Time frame: through study completion, an average of 2 years
Changes from inclusion (V1) to end of study (M24) in CBC components
Time frame: through study completion, an average of 2 years
Changes from inclusion (V1) to end of study (M24) in Folates, Vitamin B6, Vitamin B1, Vitamin D
Time frame: through study completion, an average of 2 years
Changes from inclusion (V1) to end of study (M24) in Vitamin B12
Time frame: through study completion, an average of 2 years
Changes from inclusion (V1) to end of study (M24) in TSH, prolactin
Time frame: through study completion, an average of 2 years
Changes from inclusion (V1) to end of study (M24) in drug dosage
Time frame: through study completion, an average of 2 years
Changes from inclusion in levels of pro-inflammatory cytokines and other immune biomarkers in cerebrospinal fluid, skin biopsies and/or stool, at end of acute treatment (V3), 6-month follow-up (V4), 12-month follow-up (V5) and 24-month follow-up (V6)
Time frame: At inclusion (V1), 10 weeks, 6 months-, 12 months- and 24 months after end of acute treatment
Changes from inclusion (V1) in functional (Clinical Global Impression, CGI-S and CGI-I) scores to end of acute treatment (V3)
Time frame: Up to 10 weeks
Changes from inclusion (V1) in quality of life (by WHOQOL-BREF questionnaire) scores to end of acute treatment (V3)
Time frame: Up to 10 weeks
Changes from inclusion in quality of life (by WHOQOL-BREF scores), to End Of Study (M24)
Time frame: through study completion, an average of 2 years
Changes from inclusion in functional score (by Clinical Global Impression scale), to End Of Study (M24)
Time frame: through study completion, an average of 2 years
Number of side-effects (type, intensity, severity) in total population and by cohort between study inclusion (V1) and end of study (M24)
Time frame: through study completion, an average of 2 years
Number and characteristics of biomarkers identified in the retrospectively and prospectively included populations
Time frame: through study completion, an average of 2 years
Changes from inclusion (V1) in fibrinogen, C3, C4 to End Of Study (M24)
Time frame: through study completion, an average of 2 years
Changes from inclusion (V1) to End Of Study (M24) in IL-1β, IL-6, IL-18
Time frame: through study completion, an average of 2 years
Changes from inclusion (V1) to End Of Study (M24) in cortisol dosage
Time frame: through study completion, an average of 2 years
Changes from inclusion (V1) to End Of Study (M24) in CRPus, β2 microglobulin, C1q
Time frame: through study completion, an average of 2 years
Changes from inclusion (V1) to End Of Study (M24) in anti-TPO Ab, anti-TG Ab, CH50
Time frame: through study completion, an average of 2 years
Changes from inclusion (V1) to End Of Study (M24) in anti-TRAK Ab
Time frame: through study completion, an average of 2 years
Changes from inclusion (V1) to End Of Study (M24) in neuronal Ab
Time frame: through study completion, an average of 2 years
Changes from inclusion (V1) to End Of Study (M24) in interferon signature score
Time frame: through study completion, an average of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- 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.
Anne-Cécile PETIT, MD, PhD study director
GHU Paris Psychiatry & Neurosciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling, lumbar puncture, stool sampling, skin microbiopsy and psychometrics scales in people with Schizophrenia and Treatment Resistant Depression (TRD), run by Centre Hospitalier St Anne at 1 site in France.
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 6 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 21 Sep 2026. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Iolanda PALIMARU, MD (+33145658798, iolanda.palimaru@ghu-paris.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from inclusion (V1) in disease scale scores at the end of acute phase therapy (V3) (time frame: Up to 10 weeks). The study lists 13 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 21 Sep 2026.