xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06036316</url>
    </required_header>
    <id_info>
      <org_study_id>2023-A00949-36</org_study_id>
      <nct_id>NCT06036316</nct_id>
    </id_info>
    <brief_title>Study of Language Disorders and Interactions Between Mnesic Capabilities and Semantic Competencies in Patients With Psychosis</brief_title>
    <acronym>TDLRipsy</acronym>
    <official_title>Study of Language Disorders and Interactions Between Mnesic Capabilities and Semantic Competencies in Patients With Psychosis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Centre Psychothérapique de Nancy</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Centre Psychothérapique de Nancy</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This research concerns the study of language disorders of patients present in the spectrum of&#xD;
        psychosis. It is indeed accepted that psychotic disorders are associated with language&#xD;
        difficulties, which are only poorly highlighted thanks to reusable tools in clinical&#xD;
        practice. These language disorders impact communication, and concern many linguistic domains,&#xD;
        thus covering phonology, lexicon, semantics, morphosyntax and pragmatics. It therefore seems&#xD;
        relevant to characterize these language disorders and to assess to what extent they interact&#xD;
        with the other symptoms of the pathology, in particular the course of the thought disorder&#xD;
        and the neuropsychological symptoms. In addition, this study is particularly interested in&#xD;
        the interactions between working memory capacities and those related to syntax. It is&#xD;
        intended for different patients suffering from psychotic disorders of different intensities,&#xD;
        treated in the Psychotherapeutic Center of Nancy. Patients suffering from at-risk mental&#xD;
        state (ARMS), first episode of psychosis (FEP) or schizophrenia will benefit from a complete&#xD;
        language assessment, evaluating each domain mentioned above, on the expressive and&#xD;
        understanding sides. The results of the language assessment will be compared with those of a&#xD;
        control group in the same tests. They will also be analyzed with regard to the&#xD;
        neuropsychological and psychiatric elements noted in the patient's medical file, in order to&#xD;
        highlight possible associations between language skills, neuropsychological and psychiatric&#xD;
        symptoms in this patient population.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">October 1, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>language assessment performance score</measure>
      <time_frame>day 1</time_frame>
      <description>complete speech therapy assessment evaluating each language domain. and is based on the completion of a speech therapy assessment test and on the assessment of language abilities by the experimental speech therapist.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>CAARMS Speech Disorganization Severity Score</measure>
      <time_frame>day 1</time_frame>
      <description>CAARMS: Comprehensive Assessment of At Risk Mental State</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Severity score for the disordered items of the course of thought of the SPI-A</measure>
      <time_frame>day 1</time_frame>
      <description>SPI-A:Schizophrenia Proneness Instrument</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Severity score for speech disorganization and formal thought disorders on the TLC Scale</measure>
      <time_frame>day 1</time_frame>
      <description>TLC: Thinking, Language and Communication Rating Scale</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Neuropsychological rating scales scores (CVLT)</measure>
      <time_frame>day 1</time_frame>
      <description>CVLT (California Verbal Learning test) (quantitative variable):&#xD;
  CVLT: number of correct recognitions</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Neuropsychological rating scales scores (CVLT total)</measure>
      <time_frame>day 1</time_frame>
      <description>CVLT (California Verbal Learning test) (quantitative variable):&#xD;
  CVLT total: total number of words recalled during the test Recognition</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Neuropsychological rating scales scores (Front and back spans)</measure>
      <time_frame>day 1</time_frame>
      <description>Front and back spans (quantitative variable) Front span size (number of digits recalled in front order)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Neuropsychological rating scales scores (Front and back spans 2)</measure>
      <time_frame>day 1</time_frame>
      <description>Front and back spans (quantitative variable) Reverse span size (number of digits recalled in reverse order)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Neuropsychological rating scales scores (TAP 1)</measure>
      <time_frame>day 1</time_frame>
      <description>TAP- Working Memory :Number of omissions TAP(Test of Attentional Performance) (quantitative variable)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Neuropsychological rating scales scores (TAP 2)</measure>
      <time_frame>day 1</time_frame>
      <description>TAP- Sustained attention :Number of omissions TAP(Test of Attentional Performance) (quantitative variable)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Neuropsychological rating scales scores (TAP 3)</measure>
      <time_frame>day 1</time_frame>
      <description>TAP- Flexibility :Number of errors TAP(Test of Attentional Performance) (quantitative variable)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Neuropsychological rating scales scores (TAP 4)</measure>
      <time_frame>day 1</time_frame>
      <description>TAP- Incompatibility TAP(Test of Attentional Performance) (quantitative variable)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Neuropsychological rating scales scores (TAP 5)</measure>
      <time_frame>day 1</time_frame>
      <description>TAP- Divided attention</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cannabis Abuse Screening Test (CAST) score</measure>
      <time_frame>day 1</time_frame>
      <description>CAST: Cannabis Abuse Screening Test</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">90</enrollment>
    <condition>Psychosis</condition>
    <condition>Schizophrenia</condition>
    <condition>At-risk Mental State</condition>
    <condition>Language Disorders</condition>
    <arm_group>
      <arm_group_label>early psychotic symptoms</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This group includes patients with ARMS and those with FEP. Although they are not in the same place in the continuum of psychosis, these patients benefit from the same language assessment and CAST, do not benefit from the TLC or the MINI, and the data from their neuropsychological and psychiatric assessment will be used , which is why we have chosen to bring them together in the same arm. They are between 16 and 35 years old and are cared for as part of their usual follow-up at the CPN (Nancy Psychotherapeutic Center). They must have received the diagnosis of ARMS and FEP according to the criteria of CAARMS and SPI-A.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>patients with schizophrenia</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The schizophrenic patients group will benefit from language assessment, TLC and CAST. They are between 18 and 55 years old and are cared for as part of their usual follow-up at the CPN. They must have been diagnosed with schizophrenia according to DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) criteria.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>healthy controls</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The control group for this study will be made up of volunteers between the ages of 16 and 55, not suffering from any mental disorder detected on the MINI or from a developmental disorder of oral or written language. They will also benefit from an assessment of cannabis use using the CAST.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Language assessment</intervention_name>
      <description>The proposed speech and language therapy assessment will consist of a battery of standardized tests that speech and language therapists can use to assess the language skills in reception and expression of adult patients.&#xD;
  Concerning the assessment of the interactions between working memory and semantic abilities, a complete protocol has been developed.</description>
      <arm_group_label>early psychotic symptoms</arm_group_label>
      <arm_group_label>healthy controls</arm_group_label>
      <arm_group_label>patients with schizophrenia</arm_group_label>
      <other_name>Speech and language therapy assessment</other_name>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>TLC - Scale for the Assessment of Thought, Language, and Communication</intervention_name>
      <description>This scale is frequently used in psychiatry and is used to measure formal thought disorders in patients suffering from psychosis. As part of this study, it will be intended for patients suffering from schizophrenia</description>
      <arm_group_label>patients with schizophrenia</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>MINI - Mini International Neuropsychiatric Interview</intervention_name>
      <description>This scale corresponds to a rapid assessment of the psychiatric and psychological state of patients. It helps detect any psychiatric disorders. Here, it will be offered to volunteers who are part of the control group.</description>
      <arm_group_label>healthy controls</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Combination Product</intervention_type>
      <intervention_name>CAST - Cannabis Abuse Screening Test</intervention_name>
      <description>The purpose of this questionnaire is to approximate participants' cannabis consumption and to assess any disorders associated with cannabis consumption. It will be offered to all participants, patients and healthy controls</description>
      <arm_group_label>early psychotic symptoms</arm_group_label>
      <arm_group_label>healthy controls</arm_group_label>
      <arm_group_label>patients with schizophrenia</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All Groups:&#xD;
  &#xD;
                 -  Patient affiliated or entitled to a social security scheme&#xD;
  &#xD;
                 -  Patient having received informed information on the study and having co-signed,&#xD;
                    with the investigator, a consent to participate in the study&#xD;
  &#xD;
                 -  For minor participants, at least one of the parents or holders of parental&#xD;
                    authority having been informed of the study, having received the information note&#xD;
                    relating to it and not having objected to the participation of his or her child&#xD;
  &#xD;
                 -  Native language: French&#xD;
  &#xD;
            -  ARMS and FEP Patient Group:&#xD;
  &#xD;
                 -  Age between 16 and 35 years old&#xD;
  &#xD;
                 -  Present the criteria for EMRP or FEP as defined by the Comprehensive Assessment&#xD;
                    of At Risk Mental State (CAARMS) or present the criteria for Disorders of the&#xD;
                    course of thought to the items of the Schizophrenia Proneness Instrument (SPI-A)&#xD;
  &#xD;
            -  Patients with schizophrenia group:&#xD;
  &#xD;
                 -  Age between 16 and 55 years old&#xD;
  &#xD;
                 -  Patient with diagnostic criteria for schizophrenia, as defined by DSM V (American&#xD;
                    Psychiatric Association, 2015)&#xD;
  &#xD;
                 -  Present the criteria for Disorganization of Speech and Formal Thought Disorder as&#xD;
                    defined by the Thinking, Language and Communication (TLC) Rating Scale.&#xD;
  &#xD;
            -  Healthy Volunteers Group:&#xD;
  &#xD;
                 -  Age between 16 and 55 years old&#xD;
  &#xD;
                 -  Parental authorization (of both parents) to participate in the study for minor&#xD;
                    patients&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  All groups:&#xD;
  &#xD;
                 -  Pregnant, parturient or nursing mother&#xD;
  &#xD;
                 -  Person deprived of liberty by a judicial or administrative decision&#xD;
  &#xD;
                 -  Person in a life-threatening emergency&#xD;
  &#xD;
                 -  Adult subject to a legal protection measure (guardianship, curatorship, safeguard&#xD;
                    of justice)&#xD;
  &#xD;
                 -  Adult person unable to express their consent and who is not the subject of a&#xD;
                    legal protection measure&#xD;
  &#xD;
                 -  Impairment of the subject making it difficult, if not impossible, for them to&#xD;
                    participate in the trial or to understand the information given to them&#xD;
  &#xD;
                 -  Abuse or dependence of any substance according to DSM V criteria excluding&#xD;
                    cannabis&#xD;
  &#xD;
            -  Healthy Volunteers Group:&#xD;
  &#xD;
                 -  Evolving psychiatric pathology (axis I of the DSM IV, measured at the MINI)&#xD;
                    excluding anxiety disorder&#xD;
  &#xD;
                 -  Presence of developmental disorder of oral language or written language revealed&#xD;
                    on clinical examination.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>16 Years</minimum_age>
      <maximum_age>55 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Florent Bernardin, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Centre psychothérapeutique de Nancy</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Anaëlle PAJAUD</last_name>
      <phone>0383260863</phone>
      <email>Anaelle.PAJAUD@cpn-laxou.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Naoual MELLOUKI, PhD</last_name>
      <phone>0383925267</phone>
      <email>Naoual.MELLOUKIBENDIMRED@cpn-laxou.com</email>
    </overall_contact_backup>
    <reference>
      <citation>Majerus S. Language repetition and short-term memory: an integrative framework. Front Hum Neurosci. 2013 Jul 12;7:357. doi: 10.3389/fnhum.2013.00357. eCollection 2013.</citation>
      <PMID>23874280</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 1, 2023</study_first_submitted>
    <study_first_submitted_qc>September 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Language Disorders</mesh_term>
      <mesh_term>Schizophrenia</mesh_term>
      <mesh_term>Psychotic Disorders</mesh_term>
      <mesh_term>Mental Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06036316
  org study id: 2023-A00949-36
  nct id: NCT06036316
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This research concerns the study of language disorders of patients present in the spectrum of
        psychosis. It is indeed accepted that psychotic disorders are associated with language
        difficulties, which are only poorly highlighted thanks to reusable tools in clinical
        practice. These language disorders impact communication, and concern many linguistic domains,
        thus covering phonology, lexicon, semantics, morphosyntax and pragmatics. It therefore seems
        relevant to characterize these language disorders and to assess to what extent they interact
        with the other symptoms of the pathology, in particular the course of the thought disorder
        and the neuropsychological symptoms. In addition, this study is particularly interested in
        the interactions between working memory capacities and those related to syntax. It is
        intended for different patients suffering from psychotic disorders of different intensities,
        treated in the Psychotherapeutic Center of Nancy. Patients suffering from at-risk mental
        state (ARMS), first episode of psychosis (FEP) or schizophrenia will benefit from a complete
        language assessment, evaluating each domain mentioned above, on the expressive and
        understanding sides. The results of the language assessment will be compared with those of a
        control group in the same tests. They will also be analyzed with regard to the
        neuropsychological and psychiatric elements noted in the patient's medical file, in order to
        highlight possible associations between language skills, neuropsychological and psychiatric
        symptoms in this patient population.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: language assessment performance score
  time frame: day 1
  description: complete speech therapy assessment evaluating each language domain. and is based on the completion of a speech therapy assessment test and on the assessment of language abilities by the experimental speech therapist.
  measure: CAARMS Speech Disorganization Severity Score
  time frame: day 1
  description: CAARMS: Comprehensive Assessment of At Risk Mental State
  measure: Severity score for the disordered items of the course of thought of the SPI-A
  time frame: day 1
  description: SPI-A:Schizophrenia Proneness Instrument
  measure: Severity score for speech disorganization and formal thought disorders on the TLC Scale
  time frame: day 1
  description: TLC: Thinking, Language and Communication Rating Scale
  measure: Neuropsychological rating scales scores (CVLT)
  time frame: day 1
  description: CVLT (California Verbal Learning test) (quantitative variable):
  CVLT: number of correct recognitions
  measure: Neuropsychological rating scales scores (CVLT total)
  time frame: day 1
  description: CVLT (California Verbal Learning test) (quantitative variable):
  CVLT total: total number of words recalled during the test Recognition
  measure: Neuropsychological rating scales scores (Front and back spans)
  time frame: day 1
  description: Front and back spans (quantitative variable) Front span size (number of digits recalled in front order)
  measure: Neuropsychological rating scales scores (Front and back spans 2)
  time frame: day 1
  description: Front and back spans (quantitative variable) Reverse span size (number of digits recalled in reverse order)
  measure: Neuropsychological rating scales scores (TAP 1)
  time frame: day 1
  description: TAP- Working Memory :Number of omissions TAP(Test of Attentional Performance) (quantitative variable)
  measure: Neuropsychological rating scales scores (TAP 2)
  time frame: day 1
  description: TAP- Sustained attention :Number of omissions TAP(Test of Attentional Performance) (quantitative variable)
  measure: Neuropsychological rating scales scores (TAP 3)
  time frame: day 1
  description: TAP- Flexibility :Number of errors TAP(Test of Attentional Performance) (quantitative variable)
  measure: Neuropsychological rating scales scores (TAP 4)
  time frame: day 1
  description: TAP- Incompatibility TAP(Test of Attentional Performance) (quantitative variable)
  measure: Neuropsychological rating scales scores (TAP 5)
  time frame: day 1
  description: TAP- Divided attention
  measure: Cannabis Abuse Screening Test (CAST) score
  time frame: day 1
  description: CAST: Cannabis Abuse Screening Test
  arm group label: early psychotic symptoms
  arm group type: Experimental
  description: This group includes patients with ARMS and those with FEP. Although they are not in the same place in the continuum of psychosis, these patients benefit from the same language assessment and CAST, do not benefit from the TLC or the MINI, and the data from their neuropsychological and psychiatric assessment will be used , which is why we have chosen to bring them together in the same arm. They are between 16 and 35 years old and are cared for as part of their usual follow-up at the CPN (Nancy Psychotherapeutic Center). They must have received the diagnosis of ARMS and FEP according to the criteria of CAARMS and SPI-A.
  arm group label: patients with schizophrenia
  arm group type: Experimental
  description: The schizophrenic patients group will benefit from language assessment, TLC and CAST. They are between 18 and 55 years old and are cared for as part of their usual follow-up at the CPN. They must have been diagnosed with schizophrenia according to DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) criteria.
  arm group label: healthy controls
  arm group type: Experimental
  description: The control group for this study will be made up of volunteers between the ages of 16 and 55, not suffering from any mental disorder detected on the MINI or from a developmental disorder of oral or written language. They will also benefit from an assessment of cannabis use using the CAST.
  intervention type: Behavioral
  intervention name: Language assessment
  description: The proposed speech and language therapy assessment will consist of a battery of standardized tests that speech and language therapists can use to assess the language skills in reception and expression of adult patients.
  Concerning the assessment of the interactions between working memory and semantic abilities, a complete protocol has been developed.
  arm group label: early psychotic symptoms
  arm group label: healthy controls
  arm group label: patients with schizophrenia
  other name: Speech and language therapy assessment
  intervention type: Behavioral
  intervention name: TLC - Scale for the Assessment of Thought, Language, and Communication
  description: This scale is frequently used in psychiatry and is used to measure formal thought disorders in patients suffering from psychosis. As part of this study, it will be intended for patients suffering from schizophrenia
  arm group label: patients with schizophrenia
  intervention type: Behavioral
  intervention name: MINI - Mini International Neuropsychiatric Interview
  description: This scale corresponds to a rapid assessment of the psychiatric and psychological state of patients. It helps detect any psychiatric disorders. Here, it will be offered to volunteers who are part of the control group.
  arm group label: healthy controls
  intervention type: Combination Product
  intervention name: CAST - Cannabis Abuse Screening Test
  description: The purpose of this questionnaire is to approximate participants' cannabis consumption and to assess any disorders associated with cannabis consumption. It will be offered to all participants, patients and healthy controls
  arm group label: early psychotic symptoms
  arm group label: healthy controls
  arm group label: patients with schizophrenia
  criteria: 
  gender: All
  minimum age: 16 Years
  maximum age: 55 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Florent Bernardin, PhD
  role: Principal Investigator
  affiliation: Centre psychothérapeutique de Nancy
  last name: Anaëlle PAJAUD
  phone: 0383260863
  email: Anaelle.PAJAUD@cpn-laxou.com
  last name: Naoual MELLOUKI, PhD
  phone: 0383925267
  email: Naoual.MELLOUKIBENDIMRED@cpn-laxou.com
  citation: Majerus S. Language repetition and short-term memory: an integrative framework. Front Hum Neurosci. 2013 Jul 12;7:357. doi: 10.3389/fnhum.2013.00357. eCollection 2013.
  PMID: 23874280
  responsible party type: Sponsor
  mesh term: Language Disorders
  mesh term: Schizophrenia
  mesh term: Psychotic Disorders
  mesh term: Mental Disorders
  sharing ipd: No