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Treatment Resistance in Psychiatric Disorders: the Search for Biological Markers Predictive of Response to Treatment (BIO-INM)

27 июля 2026 г. обновлено: Centre Hospitalier St Anne

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.

Обзор исследования

Статус

Еще не набирают

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Оцененный)

700

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

Места учебы

  • Франция
      • Paris, Франция, 75014
        • GHU Paris - Psychiatrie et Neurosciences
        • Контакт:

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Нет

Описание

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Другой
  • Распределение: Нерандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Другой: OCD cohort
Patients suffering from OCD resistant to treatments
Биологический: Blood sampling, lumbar puncture, stool sampling, skin microbiopsy and psychometrics scales
the biomarker research involves different biological sampling : blood, stool, cerebrospinal fluid, skin
Другой: Catatonia cohort
Patients suffering from resistant catatonia
Биологический: Blood sampling, lumbar puncture, stool sampling, skin microbiopsy and psychometrics scales
the biomarker research involves different biological sampling : blood, stool, cerebrospinal fluid, skin
Другой: TRD cohort
Patients suffering from treatment resistant depression (TRD)
Биологический: Blood sampling, lumbar puncture, stool sampling, skin microbiopsy and psychometrics scales
the biomarker research involves different biological sampling : blood, stool, cerebrospinal fluid, skin
Другой: BD cohort
Patients suffering from treatment resistant bipolar disorders (BD)
Биологический: Blood sampling, lumbar puncture, stool sampling, skin microbiopsy and psychometrics scales
the biomarker research involves different biological sampling : blood, stool, cerebrospinal fluid, skin
Другой: Schizophrenia cohort
Patients suffering from schizophrenia resistant to treatments
Биологический: Blood sampling, lumbar puncture, stool sampling, skin microbiopsy and psychometrics scales
the biomarker research involves different biological sampling : blood, stool, cerebrospinal fluid, skin

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Changes from inclusion (V1) in disease scale scores at the end of acute phase therapy (V3)
Временное ограничение: 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.
Up to 10 weeks
Changes from inclusion (V1) in disease scale scores at the end of acute phase therapy (V3)
Временное ограничение: 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.
Up to 10 weeks
Changes from inclusion (V1) in disease scale scores at the end of acute phase therapy (V3)
Временное ограничение: 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.
Up to 10 weeks
Changes from inclusion (V1) in disease scale scores at the end of acute phase therapy (V3)
Временное ограничение: 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.
Up to 10 weeks
Changes from inclusion (V1) in disease scale scores at the end of acute phase therapy (V3)
Временное ограничение: 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.
Up to 10 weeks
Changes from inclusion (V1) in disease scale scores at the end of acute phase therapy (V3)
Временное ограничение: 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.
Up to 10 weeks
Changes from inclusion (V1) in biological parameters at the end of acute phase therapy (V3).
Временное ограничение: 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
Up to 10 weeks
Changes from inclusion (V1) in biological parameters at the end of acute phase therapy (V3).
Временное ограничение: 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.
Up to 10 weeks
Changes from inclusion (V1) in biological parameters at the end of acute phase therapy (V3).
Временное ограничение: 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.
Up to 10 weeks
Changes from inclusion (V1) in biological parameters at the end of acute phase therapy (V3).
Временное ограничение: 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.
Up to 10 weeks
Changes from inclusion (V1) in biological parameters at the end of acute phase therapy (V3).
Временное ограничение: 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
Up to 10 weeks
Changes from inclusion (V1) in biological parameters at the end of acute phase therapy (V3).
Временное ограничение: 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.
Up to 10 weeks
Changes from inclusion (V1) in biological parameters at the end of acute phase therapy (V3).
Временное ограничение: 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.
Up to 10 weeks

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Changes in CRPus from inclusion (V1) to Day 2 (V2)
Временное ограничение: From enrollment to Day 2
Variation in CRPus between inclusion (V1) and Day 2 (V2) in mg/L.
From enrollment to Day 2
Changes in immunity markers from inclusion (V1) to Day 2 (V2)
Временное ограничение: From enrollment to Day 2
Variation in IL-1β, IL-6, and IL-18 between inclusion (V1) and Day 2 (V2) in pg/mL.
From enrollment to Day 2
Changes from inclusion (V1) in standardized clinical disease scale scores at Day 2 (V2)
Временное ограничение: From enrollment to Day 2
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.
From enrollment to Day 2
Changes from inclusion (V1) in standardized clinical disease scale scores at Day 2 (V2)
Временное ограничение: From enrollment to Day 2
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.
From enrollment to Day 2
Changes from inclusion (V1) in standardized clinical disease scale scores at Day 2 (V2)
Временное ограничение: From enrollment to Day 2
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.
From enrollment to Day 2
Changes from inclusion (V1) in standardized clinical disease scale scores at Day 2 (V2)
Временное ограничение: From enrollment to Day 2
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.
From enrollment to Day 2
Changes from inclusion (V1) in standardized clinical disease scale scores at Day 2 (V2)
Временное ограничение: From enrollment to Day 2
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.
From enrollment to Day 2
Changes from inclusion (V1) in standardized clinical disease scale scores at Day 2 (V2)
Временное ограничение: From enrollment to Day 2
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.
From enrollment to Day 2
Changes from inclusion (V1) to end of study (M24) in standardized clinical disease scale scores
Временное ограничение: through study completion, an average of 2 years
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.
through study completion, an average of 2 years
Changes from inclusion (V1) to end of study (M24) in standardized clinical disease scale scores
Временное ограничение: through study completion, an average of 2 years
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.
through study completion, an average of 2 years
Changes from inclusion (V1) to end of study (M24) in standardized clinical disease scale scores
Временное ограничение: through study completion, an average of 2 years

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.
through study completion, an average of 2 years
Changes from inclusion (V1) to end of study (M24) in standardized clinical disease scale scores
Временное ограничение: through study completion, an average of 2 years
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.
through study completion, an average of 2 years
Changes from inclusion (V1) to end of study (M24) in standardized clinical disease scale scores
Временное ограничение: through study completion, an average of 2 years

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.
through study completion, an average of 2 years
Changes from inclusion (V1) to end of study (M24) in standardized clinical disease scale scores
Временное ограничение: through study completion, an average of 2 years
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.
through study completion, an average of 2 years
Changes from inclusion (V1) to end of study (M24) in CBC components
Временное ограничение: through study completion, an average of 2 years
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.
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
Временное ограничение: through study completion, an average of 2 years
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.
through study completion, an average of 2 years
Changes from inclusion (V1) to end of study (M24) in Vitamin B12
Временное ограничение: through study completion, an average of 2 years
Changes in Vitamin B12 measured between inclusion (V1) and the End Of Study (M24) in pg/mL.
through study completion, an average of 2 years
Changes from inclusion (V1) to end of study (M24) in TSH, prolactin
Временное ограничение: through study completion, an average of 2 years
Changes in biological parameters measured between inclusion (V1) and End Of Study (M24). The dosages are : TSH, prolactin in mUI/L
through study completion, an average of 2 years
Changes from inclusion (V1) to end of study (M24) in drug dosage
Временное ограничение: through study completion, an average of 2 years
Variation in drug dosage between inclusion (V1) and End Of Study (M24). Unit could be different according to the drug.
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)
Временное ограничение: At inclusion (V1), 10 weeks, 6 months-, 12 months- and 24 months after end of acute treatment
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.
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)
Временное ограничение: Up to 10 weeks

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).
Up to 10 weeks
Changes from inclusion (V1) in quality of life (by WHOQOL-BREF questionnaire) scores to end of acute treatment (V3)
Временное ограничение: Up to 10 weeks
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.
Up to 10 weeks
Changes from inclusion in quality of life (by WHOQOL-BREF scores), to End Of Study (M24)
Временное ограничение: through study completion, an average of 2 years
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.
through study completion, an average of 2 years
Changes from inclusion in functional score (by Clinical Global Impression scale), to End Of Study (M24)
Временное ограничение: through study completion, an average of 2 years

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).
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)
Временное ограничение: through study completion, an average of 2 years
Side-effects (type, intensity, severity) in total population and by cohort between study inclusion and End Of Study (M24)
through study completion, an average of 2 years
Number and characteristics of biomarkers identified in the retrospectively and prospectively included populations
Временное ограничение: through study completion, an average of 2 years
The number and characteristics of biomarkers identified in the retrospectively and prospectively included populations throughout the study
through study completion, an average of 2 years
Changes from inclusion (V1) in fibrinogen, C3, C4 to End Of Study (M24)
Временное ограничение: through study completion, an average of 2 years
Changes in biological parameters measured between inclusion (V1) and the end of study (M24). The dosages are : C3, C4, fibrinogen in g/L.
through study completion, an average of 2 years
Changes from inclusion (V1) to End Of Study (M24) in IL-1β, IL-6, IL-18
Временное ограничение: through study completion, an average of 2 years
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.
through study completion, an average of 2 years
Changes from inclusion (V1) to End Of Study (M24) in cortisol dosage
Временное ограничение: through study completion, an average of 2 years
Changes in cortisol measured between inclusion (V1) and the end of study (M24) in nmol/L.
through study completion, an average of 2 years
Changes from inclusion (V1) to End Of Study (M24) in CRPus, β2 microglobulin, C1q
Временное ограничение: through study completion, an average of 2 years
Changes in biological parameters measured between inclusion (V1) and End Of Study (M24). The dosages are : CRPus, β2 microglobulin, C1q in mg/L.
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
Временное ограничение: through study completion, an average of 2 years
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.
through study completion, an average of 2 years
Changes from inclusion (V1) to End Of Study (M24) in anti-TRAK Ab
Временное ограничение: through study completion, an average of 2 years
Variation in anti TSH receptor specific Antibodies (anti-TRAK Ab) between inclusion (V1) and End Of Study (M24)
through study completion, an average of 2 years
Changes from inclusion (V1) to End Of Study (M24) in neuronal Ab
Временное ограничение: through study completion, an average of 2 years
Number of positive neuronal antibodies between inclusion (V1) and End Of Study (M24)
through study completion, an average of 2 years
Changes from inclusion (V1) to End Of Study (M24) in interferon signature score
Временное ограничение: through study completion, an average of 2 years
Variation in interferon signature score between inclusion (V1) and End Of Study (M24)
through study completion, an average of 2 years

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Centre Hospitalier St Anne

Соавторы

GHU Paris Psychiatry & Neurosciences

Следователи

  • Директор по исследованиям: Anne-Cécile PETIT, MD, PhD, GHU Paris Psychiatry & Neurosciences

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Оцененный)

15 июля 2026 г.

Первичное завершение (Оцененный)

1 октября 2036 г.

Завершение исследования (Оцененный)

1 августа 2038 г.

Даты регистрации исследования

Первый отправленный

29 июня 2026 г.

Впервые представлено, что соответствует критериям контроля качества

27 июля 2026 г.

Первый опубликованный (Действительный)

3 августа 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

3 августа 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

27 июля 2026 г.

Последняя проверка

1 июня 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • D25-P041
  • N°ID-RCB: 2026-A00433-48 (Другой идентификатор: ANSM)

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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