Mental DisorderPhase 3TIM-DePisTNCT05946486
Evaluation of the Efficacy of Immunomodulatory Therapy in Case of Psychiatric Disorders With Proven Dysimmunity.
A Phase 3 study testing immunomodulatory treatment by rituximab in people with Mental Disorder, run by University Hospital, Bordeaux at 9 sites in France.
Trial summary
This is an open phase III randomized clinical trial studying the superiority of management by immunomodulator treatment of psychiatric disorders (psychosis and bipolar disorders) for patients previously identified as carriers of autoimmunity such as as the presence of a pathogenic anti-glutamatergic NMDA receptor… Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Mental Disorder
- What is being tested?
- immunomodulatory treatment by rituximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 9 sitesFrance
- Study dates
- 15 Oct 2023to 15 Dec 2026
- Phase
- Phase 3
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- For Adult: First acute or relapse of psychotic disorders defined by the BPRS-E scale with or without standard pharmacological treatment.
- For Children: Child over 6 years old with a first acute or relapse of psychotic disorders defined by the Kiddie sads-PL scale with or without standard pharmacological treatment.
- Biological diagnosis of pathogenic CNS autoantibodies in the blood.
- MDC scale score >3 is required for inclusion in step 2.
- Normal ECG in case of previous heart disease.
- Informed consent of the patient or his legal representatives.
- Effective contraception for women of childbearing potential during the study and for at least 12 months after the last rituximab administration.
Who cannot join
- Developmental disorder related to a genetic disease.
- Co-existing disorder of severe neurological disease.
- Chronic psychotic disorders receiving ongoing neuroleptic treatment with efficacy.
- Hypersensitivity to the active substance (rituximab) or to murine proteins, or to any of the other excipients
- Blood platelets < 75x109/L
- Neutrophils < 1.5x109/L
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- Neoplastic pathology,
- Hepatitis B or HIV infection,
- Contraindication to immunosuppressant treatment (active severe infection, severely immunocompromised state).
- Severe heart failure (New York Heart Association Class IV) or severe, uncontrolled cardiac disease
- Pregnant or breastfeeding women
- Currently receiving an investigational drug or received an investigational drug or device within 30 days (or 5 half-lives for drugs, whichever is longer) prior to screening.
- Previous treatment with rituximab in the past 12 months.
- Patients with a history of recurring or chronic infections or with underlying conditions which may further predispose them to serious infection (e.g. hypogammaglobulinemia).
- Recent vaccination with live viral vaccine (within 3 months).
- Any other medical illness or disability that, in the opinion of the investigator, would compromise effective trial participation.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
France9 sites
Centre Hospitalier Charles Perrens
Bordeaux
Bruno Aouizerate
Anouck Amestoy
CHU de Bordeaux
Bordeaux
Frédéric Villega
Valérie Adrian
Centre hospitalier le Vinatier
Bron
Romain Rey
CHU de Clermond Ferrand
Clermont-Ferrand
Pierre-Michel Llorca
APHP Louis Mourier
Colombes
Catherine Dubertet
APHP Henri Mondor
Créteil
Marion Leboyer
APHP Kremlin Bicetre
Le Kremlin-Bicêtre
Kumaran Deiva
CHU de Montpellier
Montpellier
Delphine Capdevielle
CHU de Strasbourg
Strasbourg
Fabrice Berna
About this study
Official title: Phase III Randomized, Multicenter Open Label Study to Evaluate the Efficacy of Immunomodulatory Therapy in Case of Psychiatric Disorders With Proven Dysimmunity.
This is an open phase III randomized clinical trial studying the superiority of management by immunomodulator treatment of psychiatric disorders (psychosis and bipolar disorders) for patients previously identified as carriers of autoimmunity such as as the presence of a pathogenic anti-glutamatergic NMDA receptor antibody (NMDAr-Ac).
Read the detailed description
This is an open phase III randomized clinical trial studying the superiority of management by immunomodulator treatment of psychiatric disorders (psychosis and bipolar disorders) for patients previously identified as carriers of autoimmunity such as as the presence of a pathogenic anti-glutamatergic NMDA receptor antibody (NMDAr-Ac). The aim is to assess the clinical efficacy of this treatment associated with the usual recommended psychotropic treatment. To meet this objective, we will use, via a National Center for Scientific Research (CNRS) Research laboratory in Bordeaux, a very sensitive diagnostic platform to detect and demonstrate the pathogenesis of antibodies in patient serum. This platform is operational only within the framework of validation of the results by the reference center for neurological autoimmune diseases in Lyon
- Conditions
- Mental Disorder
- Being tested
- immunomodulatory treatment by rituximab
- Keywords
- psychotic disorders, pathogenic central nervous system (CNS) autoantibodies, immunomodulatory therapy
- Medical subject headings
- Mental Disorders, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immunomodulatory treatment by rituximabDrug
1g for adults or 375 mg/m2 for children, renewed at 14 days (+/- 3 days)
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | continuation of ongoing psychiatric care (with or without standard treatment as usual (i.e. antipsychotics, mood stabilisers, antidepressants and/or anxiolytics)). |
| experimental group | Experimental | immunomodulatory treatment by rituximab, 1g for adults or 375 mg/m2 for children, renewed at 14 days (+/- 3 days), added to stable ongoing psychiatric care (with or without standard treatment as usual ( i.e. antipsychotic, mood stabiliser, antidepressant and/or anxiolytic)). The rituximab is the best immunomodulatory treatment recommended for neurologic encephalitis. Receives: Drug: immunomodulatory treatment by rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adult patients : the remission of psychiatric symptoms at 3 months
The primary endpoint outcome is the remission of psychiatric symptoms at 3 months, defined as:
- For adult patients: 20% decrease from baseline of Brief psychiatric rating scale-Extended (BPRS-E scale).
Measured: 3 months after randomization
Minor patients : the remission of psychiatric symptoms at 3 months
The primary endpoint outcome is the remission of psychiatric symptoms at 3 months, defined as:
- For patients <18years or adults patients included at adolescent age at 2nd step inclusion visit: clinically significant difference ≤3 from baseline of CBCL/6-18 (Child Behavior Checklist) scale.
Measured: 3 months after randomization
Secondary outcomes (14)
Adult Patients : the remission of psychiatric symptoms at 12 months
the remission of psychiatric symptoms defined as:
- For adult patients: 20% decrease from baseline of Brief psychiatric rating scale-Extended (BPRS-E scale).
Measured: 12 months after randomization
Adult Patients : the remission of psychiatric symptoms at 6 months
the remission of psychiatric symptoms defined as:
- For adult patients: 20% decrease from baseline of Brief psychiatric rating scale-Extended (BPRS-E scale).
Measured: 6 months after randomization
Adult Patients : the remission of psychiatric symptoms at 1 month
the remission of psychiatric symptoms defined as:
- For adult patients: 20% decrease from baseline of Brief psychiatric rating scale-Extended (BPRS-E scale).
Measured: 1 month after randomization
Minor patients : the remission of psychiatric symptoms at 12 months
The primary endpoint outcome is the remission of psychiatric symptoms at 12 months, defined as:
- For patients <18years or adults patients included at adolescent age at 2nd step inclusion visit: clinically significant difference ≤3 from baseline of CBCL/6-18 (Child Behavior Checklist) scale.
Measured: 12 months after randomization
Minor patients : the remission of psychiatric symptoms at 6 months
The primary endpoint outcome is the remission of psychiatric symptoms, defined as:
- For patients <18years or adults patients included at adolescent age at 2nd step inclusion visit: clinically significant difference ≤3 from baseline of CBCL/6-18 (Child Behavior Checklist) scale.
Measured: 6 months after randomization
Minor patients : the remission of psychiatric symptoms at 1 month
The primary endpoint outcome is the remission of psychiatric symptoms, defined as:
- For patients <18years or adults patients included at adolescent age at 2nd step inclusion visit: clinically significant difference ≤3 from baseline of CBCL/6-18 (Child Behavior Checklist) scale.
Measured: 1 month after randomization
Adult patients : general functioning at 1 month
for Global assessment of functioning scale (GAF scale), a mean score of 60 and above is expected to be achieved indicating patients experiencing mild to moderate symptoms and functioning pretty well in daily life.
Measured: 1 month after randomization
Adult patients : general functioning at 3 months
for Global assessment of functioning scale (GAF scale), a mean score of 60 and above is expected to be achieved indicating patients experiencing mild to moderate symptoms and functioning pretty well in daily life.
Measured: 3 months after randomization
Adult patients : general functioning at 6 months
for Global assessment of functioning scale (GAF scale), a mean score of 60 and above is expected to be achieved indicating patients experiencing mild to moderate symptoms and functioning pretty well in daily life.
Measured: 6 months after randomization
Adult patients : general functioning at 12 months
for Global assessment of functioning scale (GAF scale), a mean score of 60 and above is expected to be achieved indicating patients experiencing mild to moderate symptoms and functioning pretty well in daily life.
Measured: 12 months after randomization
Minor patients : Child behaviour check list (CBCL) /6-18 scale at 1 month
For children>6 years old with an acute first episode or relapse of psychotic disorders: clinically significant difference ≤3 from baseline of CBCL/6-18 (Child Behavior Checklist) scale.
Measured: 1 month after randomization
Minor patients : Child behaviour check list (CBCL) /6-18 scale at 3 months
For children>6 years old with an acute first episode or relapse of psychotic disorders: clinically significant difference ≤3 from baseline of CBCL/6-18 (Child Behavior Checklist) scale.
Measured: 3 months after randomization
Minor patients : Child behaviour check list (CBCL) /6-18 scale at 6 months
For children>6 years old with an acute first episode or relapse of psychotic disorders: clinically significant difference ≤3 from baseline of CBCL/6-18 (Child Behavior Checklist) scale.
Measured: 6 months after randomization
Minor patients : Child behaviour check list (CBCL) /6-18 scale at 12 months
For children>6 years old with an acute first episode or relapse of psychotic disorders: clinically significant difference ≤3 from baseline of CBCL/6-18 (Child Behavior Checklist) scale.
Measured: 12 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start15 Oct 2023 (estimated)
- Primary completion15 Jan 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric VILLEGA, MD, PhD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05946486
- Sponsor's protocol ID
- CHUBX 2019/59
- Acronym
- TIM-DePisT
- Status last verified
- Jul 2023
- First submitted
- 7 Jul 2023
- Last updated
- 14 Jul 2023
- 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 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomized, Multicenter Open Label Study to Evaluate the Efficacy of Immunomodulatory Therapy in Case of Psychiatric Disorders With Proven Dysimmunity.
- ClinicalTrials.gov ID
- NCT05946486
- Acronym / sponsor ID
- TIM-DePisT / CHUBX 2019/59
- Conditions
- Mental Disorder
- Keywords
- psychotic disorders, pathogenic central nervous system (CNS) autoantibodies, immunomodulatory therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 15 Oct 2023 (estimated)
- Primary completion
- 15 Jan 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 14 Jul 2023 (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 open phase III randomized clinical trial studying the superiority of management by immunomodulator treatment of psychiatric disorders (psychosis and bipolar disorders) for patients previously identified as carriers of autoimmunity such as as the presence of a pathogenic anti-glutamatergic NMDA receptor antibody (NMDAr-Ac).
Detailed description
This is an open phase III randomized clinical trial studying the superiority of management by immunomodulator treatment of psychiatric disorders (psychosis and bipolar disorders) for patients previously identified as carriers of autoimmunity such as as the presence of a pathogenic anti-glutamatergic NMDA receptor antibody (NMDAr-Ac). The aim is to assess the clinical efficacy of this treatment associated with the usual recommended psychotropic treatment. To meet this objective, we will use, via a National Center for Scientific Research (CNRS) Research laboratory in Bordeaux, a very sensitive diagnostic platform to detect and demonstrate the pathogenesis of antibodies in patient serum. This platform is operational only within the framework of validation of the results by the reference center for neurological autoimmune diseases in Lyon
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –continuation of ongoing psychiatric care (with or without standard treatment as usual (i.e. antipsychotics, mood stabilisers, antidepressants and/or anxiolytics)). |
| experimental group | Experimental | Drug: immunomodulatory treatment by rituximabimmunomodulatory treatment by rituximab, 1g for adults or 375 mg/m2 for children, renewed at 14 days (+/- 3 days), added to stable ongoing psychiatric care (with or without standard treatment as usual ( i.e. antipsychotic, mood stabiliser, antidepressant and/or anxiolytic)). The rituximab is the best immunomodulatory treatment recommended for neurologic encephalitis. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- For Adult: First acute or relapse of psychotic disorders defined by the BPRS-E scale with or without standard pharmacological treatment.
- For Children: Child over 6 years old with a first acute or relapse of psychotic disorders defined by the Kiddie sads-PL scale with or without standard pharmacological treatment.
- Biological diagnosis of pathogenic CNS autoantibodies in the blood.
- MDC scale score >3 is required for inclusion in step 2.
- Normal ECG in case of previous heart disease.
Key exclusion criteria (16 listed)
- Developmental disorder related to a genetic disease.
- Co-existing disorder of severe neurological disease.
- Chronic psychotic disorders receiving ongoing neuroleptic treatment with efficacy.
- Hypersensitivity to the active substance (rituximab) or to murine proteins, or to any of the other excipients
- Blood platelets < 75x109/L
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 |
|---|---|---|
| immunomodulatory treatment by rituximab1g for adults or 375 mg/m2 for children, renewed at 14 days (+/- 3 days) | Drug | experimental group |
Primary outcome
Adult patients : the remission of psychiatric symptoms at 3 months
Time frame: 3 months after randomization
The primary endpoint outcome is the remission of psychiatric symptoms at 3 months, defined as: - For adult patients: 20% decrease from baseline of Brief psychiatric rating scale-Extended (BPRS-E scale).
Minor patients : the remission of psychiatric symptoms at 3 months
Time frame: 3 months after randomization
The primary endpoint outcome is the remission of psychiatric symptoms at 3 months, defined as: - For patients <18years or adults patients included at adolescent age at 2nd step inclusion visit: clinically significant difference ≤3 from baseline of CBCL/6-18 (Child Behavior Checklist) scale.
14 secondary outcomes
Adult Patients : the remission of psychiatric symptoms at 12 months
Time frame: 12 months after randomization
Adult Patients : the remission of psychiatric symptoms at 6 months
Time frame: 6 months after randomization
Adult Patients : the remission of psychiatric symptoms at 1 month
Time frame: 1 month after randomization
Minor patients : the remission of psychiatric symptoms at 12 months
Time frame: 12 months after randomization
Minor patients : the remission of psychiatric symptoms at 6 months
Time frame: 6 months after randomization
Minor patients : the remission of psychiatric symptoms at 1 month
Time frame: 1 month after randomization
Adult patients : general functioning at 1 month
Time frame: 1 month after randomization
Adult patients : general functioning at 3 months
Time frame: 3 months after randomization
Adult patients : general functioning at 6 months
Time frame: 6 months after randomization
Adult patients : general functioning at 12 months
Time frame: 12 months after randomization
Minor patients : Child behaviour check list (CBCL) /6-18 scale at 1 month
Time frame: 1 month after randomization
Minor patients : Child behaviour check list (CBCL) /6-18 scale at 3 months
Time frame: 3 months after randomization
Minor patients : Child behaviour check list (CBCL) /6-18 scale at 6 months
Time frame: 6 months after randomization
Minor patients : Child behaviour check list (CBCL) /6-18 scale at 12 months
Time frame: 12 months after randomization
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 14 Jul 2023.
- 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.
Frédéric VILLEGA, MD, PhD principal investigator
University Hospital, Bordeaux
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing immunomodulatory treatment by rituximab in people with Mental Disorder, run by University Hospital, Bordeaux at 9 sites 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 7 inclusion and 16 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: opening soon, as of the sponsor's last update on 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Frédéric VILLEGA, MD, PhD (+33 (0)5 56 79 56 41, frederic.villega@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adult patients : the remission of psychiatric symptoms at 3 months (time frame: 3 months after randomization). 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 14 Jul 2023.