CHU de Nîmes
Nîmes, 30029, France
Location contact
Anissa Megzari
CONTACT
Aurélie Schandrin
SUB_INVESTIGATOR
Julie Jourdan
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07330843
First episode psychosis (FEP) constitutes an important subgroup within psychotic disorders, as the acute impact of a disorder at the time of diagnosis may differ from its long-term impact over the following decades. Narrative is identified as a sense of personal agency, of belonging to a social group, metacognition, and well-being. Patients with schizophrenia have lower levels of agency and communion compared to HIV-positive participants. However, the themes of agency and communion and metacognition do not reflect all factors representing narrative identity. In order to measure well-being, it is also necessary to introduce a specific and multidimensional measure that will allow a more precise understanding of the phenomenon.
In FEP, a link has been demonstrated between the specificity of self-recollection and functional outcomes. Given that the transitional developmental stage between adolescence and adulthood is a key developmental window for narrative identity as well as psychotic disorders and that narrative identity is positively associated with mental health, this study will therefore focus on the acquisition of narrative identity in the FEP. It will investigate the extent to which narrative identity has an impact on multidimensional subjective well-being and whether it can predict multidimensional subjective well-being over time. The study investigators hypothesize that the levels of the various components of narrative identity would be lower in cases of FEP compared to patients with other "chronic" psychotic conditions and controls.
Trial opening soon.
Get Notified16 year–30 year
All sexes
Observational
Nîmes, 30029, France
Anissa Megzari
CONTACT
Aurélie Schandrin
SUB_INVESTIGATOR
Julie Jourdan
PRINCIPAL_INVESTIGATOR
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
For the FEP group:
For the "Chronic" group:
Exclusion criteria
For the FEP group:
For the "Control" group:
Participants will be asked to elaborate five personal narratives in response to the different types of questions: trauma, transgression, negative memory, self-definition, and turning point.
Time frame: Baseline (Day 0)
7-point scale ranging from -3 "Extremely negative" to 3 "Extremely positive"
Time frame: Month 6
7-point scale ranging from -3 "Extremely negative" to 3 "Extremely positive"
Time frame: Month 12
7-point scale ranging from -3 "Extremely negative" to 3 "Extremely positive"
Time frame: Month 18
7-point scale ranging from -3 "Extremely negative" to 3 "Extremely positive"
Time frame: Month 24
7-point scale ranging from -3 "Extremely negative" to 3 "Extremely positive"
Time frame: Baseline (Day 0)
7-point scale ranging from 1 "Not at all intense" to 7 "Extremely intense" -
Time frame: Month 6
7-point scale ranging from 1 "Not at all intense" to 7 "Extremely intense" -
Time frame: Month 12
7-point scale ranging from 1 "Not at all intense" to 7 "Extremely intense" -
Time frame: Month 18
7-point scale ranging from 1 "Not at all intense" to 7 "Extremely intense" -
Time frame: Month 24
7-point scale ranging from 1 "Not at all intense" to 7 "Extremely intense" -
Time frame: Baseline (day 0)
4-point scale ranging from 0 "Negative" to 4 "Positive."
Time frame: Month 6
4-point scale ranging from 0 "Negative" to 4 "Positive."
Time frame: Month 12
4-point scale ranging from 0 "Negative" to 4 "Positive."
Time frame: Month 18
4-point scale ranging from 0 "Negative" to 4 "Positive."
Time frame: Month 24
4-point scale ranging from 0 "Negative" to 4 "Positive."
Time frame: Baseline (Day 0)
PERMA Profiler questionnaire; a 15-item scale in which higher scores indicate greater well-being
Time frame: Month 6
PERMA Profiler questionnaire; a 15-item scale in which higher scores indicate greater well-being
Time frame: Month 12
PERMA Profiler questionnaire; a 15-item scale in which higher scores indicate greater well-being
Time frame: Month 18
PERMA Profiler questionnaire; a 15-item scale in which higher scores indicate greater well-being
Time frame: Month 24
PERMA Profiler questionnaire; a 15-item scale in which higher scores indicate greater well-being
Time frame: Baseline (day 0)
EQ5D-5L questionnaire comprising five items representing the five dimensions, and a visual analog scale ranging from 0 to 100 (100 referring to the "best possible health state"). The responses are then into a 5-digit number describing the patient's health state (e.g "11111" indicates the absence of problems).
Time frame: Month 6
EQ5D-5L questionnaire comprising five items representing the five dimensions, and a visual analog scale ranging from 0 to 100 (100 referring to the "best possible health state"). The responses are then into a 5-digit number describing the patient's health state (e.g "11111" indicates the absence of problems).
Time frame: Month 12
EQ5D-5L questionnaire comprising five items representing the five dimensions, and a visual analog scale ranging from 0 to 100 (100 referring to the "best possible health state"). The responses are then into a 5-digit number describing the patient's health state (e.g "11111" indicates the absence of problems).
Time frame: Month 18
EQ5D-5L questionnaire comprising five items representing the five dimensions, and a visual analog scale ranging from 0 to 100 (100 referring to the "best possible health state"). The responses are then into a 5-digit number describing the patient's health state (e.g "11111" indicates the absence of problems).
Time frame: Month 24
EQ5D-5L questionnaire comprising five items representing the five dimensions, and a visual analog scale ranging from 0 to 100 (100 referring to the "best possible health state"). The responses are then into a 5-digit number describing the patient's health state (e.g "11111" indicates the absence of problems).
Time frame: Baseline (day 0)
WHOQOL-Brief: a 26-item questionnaire including one item on overall quality of life, one item assessing general health, and one item from each of the 24 facets of the WHOQOL-100. Four types of five-point response scales measure intensity (Not at all-Extremely), capacity (Not at all-Completely), frequency (Never-Always), and evaluation (Very dissatisfied/Very poor-Very satisfied/Very good).
Time frame: Month 6
WHOQOL-Brief: a 26-item questionnaire including one item on overall quality of life, one item assessing general health, and one item from each of the 24 facets of the WHOQOL-100. Four types of five-point response scales measure intensity (Not at all-Extremely), capacity (Not at all-Completely), frequency (Never-Always), and evaluation (Very dissatisfied/Very poor-Very satisfied/Very good).
Time frame: Month 12
WHOQOL-Brief: a 26-item questionnaire including one item on overall quality of life, one item assessing general health, and one item from each of the 24 facets of the WHOQOL-100. Four types of five-point response scales measure intensity (Not at all-Extremely), capacity (Not at all-Completely), frequency (Never-Always), and evaluation (Very dissatisfied/Very poor-Very satisfied/Very good).
Time frame: Month 18
WHOQOL-Brief: a 26-item questionnaire including one item on overall quality of life, one item assessing general health, and one item from each of the 24 facets of the WHOQOL-100. Four types of five-point response scales measure intensity (Not at all-Extremely), capacity (Not at all-Completely), frequency (Never-Always), and evaluation (Very dissatisfied/Very poor-Very satisfied/Very good).
Time frame: Month 24
WHOQOL-Brief: a 26-item questionnaire including one item on overall quality of life, one item assessing general health, and one item from each of the 24 facets of the WHOQOL-100. Four types of five-point response scales measure intensity (Not at all-Extremely), capacity (Not at all-Completely), frequency (Never-Always), and evaluation (Very dissatisfied/Very poor-Very satisfied/Very good).
Time frame: Baseline (Day 0)
Hospital Anxiety and Depression Scale questionnaire where a higher score indicates greater distress
Time frame: Month 6
Hospital Anxiety and Depression Scale questionnaire where a higher score indicates greater distress
Time frame: Month 12
Hospital Anxiety and Depression Scale questionnaire where a higher score indicates greater distress
Time frame: Month 18
Hospital Anxiety and Depression Scale questionnaire where a higher score indicates greater distress
Time frame: Month 24
Hospital Anxiety and Depression Scale questionnaire where a higher score indicates greater distress
Time frame: Baseline (day 0)
Thinking About Life Experiences scale (TALE-15): 17-item questionnaire consists of two general questions followed by 15 specific items related to the functions of autobiographical memory, each composed of 5 sub-items. Responses are rated on a 5-point Likert scale ranging from "Almost never" to "Very frequently."
Time frame: Month 6
Thinking About Life Experiences scale (TALE-15): 17-item questionnaire consists of two general questions followed by 15 specific items related to the functions of autobiographical memory, each composed of 5 sub-items. Responses are rated on a 5-point Likert scale ranging from "Almost never" to "Very frequently."
Time frame: Month 12
Thinking About Life Experiences scale (TALE-15): 17-item questionnaire consists of two general questions followed by 15 specific items related to the functions of autobiographical memory, each composed of 5 sub-items. Responses are rated on a 5-point Likert scale ranging from "Almost never" to "Very frequently."
Time frame: Month 18
Thinking About Life Experiences scale (TALE-15): 17-item questionnaire consists of two general questions followed by 15 specific items related to the functions of autobiographical memory, each composed of 5 sub-items. Responses are rated on a 5-point Likert scale ranging from "Almost never" to "Very frequently."
Time frame: Month 24
Thinking About Life Experiences scale (TALE-15): 17-item questionnaire consists of two general questions followed by 15 specific items related to the functions of autobiographical memory, each composed of 5 sub-items. Responses are rated on a 5-point Likert scale ranging from "Almost never" to "Very frequently."
Time frame: Baseline (day 0)
Big Five Inventory (BFI-10): assessing the five major personality traits: extraversion, agreeableness, conscientiousness, emotional stability, and openness.
Time frame: Month 6
Big Five Inventory (BFI-10): assessing the five major personality traits: extraversion, agreeableness, conscientiousness, emotional stability, and openness.
Time frame: Month 12
Big Five Inventory (BFI-10): assessing the five major personality traits: extraversion, agreeableness, conscientiousness, emotional stability, and openness.
Time frame: Month 18
Big Five Inventory (BFI-10): assessing the five major personality traits: extraversion, agreeableness, conscientiousness, emotional stability, and openness.
Time frame: Month 24
Big Five Inventory (BFI-10): assessing the five major personality traits: extraversion, agreeableness, conscientiousness, emotional stability, and openness.
Time frame: Baseline (day 0)
Positive and negative symptom scale (PANSS). 30 items measuring 5 subscales: positive, negative, disorganization, hostility, and anxiety. Each item is rated on a 7-point Likert scale ranging from 1 (absent) to 7 (extreme). The positive subscale ranges from 7 to 49, the negative subscale from 8 to 56, the hostility subscale from 6 to 46, the disorganization subscale from 5 to 35, and the anxiety subscale from 4 to 28. The total score ranges from 30 to 210.
Time frame: Month 6
Positive and negative symptom scale (PANSS). 30 items measuring 5 subscales: positive, negative, disorganization, hostility, and anxiety. Each item is rated on a 7-point Likert scale ranging from 1 (absent) to 7 (extreme). The positive subscale ranges from 7 to 49, the negative subscale from 8 to 56, the hostility subscale from 6 to 46, the disorganization subscale from 5 to 35, and the anxiety subscale from 4 to 28. The total score ranges from 30 to 210.
Time frame: Month 12
Positive and negative symptom scale (PANSS). 30 items measuring 5 subscales: positive, negative, disorganization, hostility, and anxiety. Each item is rated on a 7-point Likert scale ranging from 1 (absent) to 7 (extreme). The positive subscale ranges from 7 to 49, the negative subscale from 8 to 56, the hostility subscale from 6 to 46, the disorganization subscale from 5 to 35, and the anxiety subscale from 4 to 28. The total score ranges from 30 to 210.
Time frame: Month 18
Positive and negative symptom scale (PANSS). 30 items measuring 5 subscales: positive, negative, disorganization, hostility, and anxiety. Each item is rated on a 7-point Likert scale ranging from 1 (absent) to 7 (extreme). The positive subscale ranges from 7 to 49, the negative subscale from 8 to 56, the hostility subscale from 6 to 46, the disorganization subscale from 5 to 35, and the anxiety subscale from 4 to 28. The total score ranges from 30 to 210.
Time frame: Month 24
Positive and negative symptom scale (PANSS). 30 items measuring 5 subscales: positive, negative, disorganization, hostility, and anxiety. Each item is rated on a 7-point Likert scale ranging from 1 (absent) to 7 (extreme). The positive subscale ranges from 7 to 49, the negative subscale from 8 to 56, the hostility subscale from 6 to 46, the disorganization subscale from 5 to 35, and the anxiety subscale from 4 to 28. The total score ranges from 30 to 210.
Time frame: Baseline (day 0)
Global Assessment of Functioning (GAF). This numerical scale (from 0 to 100) subjectively assesses functioning in social, occupational, and psychological domains. Lower scores represent lower levels of functioning
Time frame: Month 6
Global Assessment of Functioning (GAF). This numerical scale (from 0 to 100) subjectively assesses functioning in social, occupational, and psychological domains. Lower scores represent lower levels of functioning
Time frame: Month 12
Global Assessment of Functioning (GAF). This numerical scale (from 0 to 100) subjectively assesses functioning in social, occupational, and psychological domains. Lower scores represent lower levels of functioning
Time frame: Month 18
Global Assessment of Functioning (GAF). This numerical scale (from 0 to 100) subjectively assesses functioning in social, occupational, and psychological domains. Lower scores represent lower levels of functioning
Time frame: Month 24
Global Assessment of Functioning (GAF). This numerical scale (from 0 to 100) subjectively assesses functioning in social, occupational, and psychological domains. Lower scores represent lower levels of functioning
Time frame: Baseline (day 0)
Stage of recovery instrument (STORI): a 50-item questionnaire that evaluates the five stages of personal recovery. Ten themes are assessed, each containing five items ranging from 0 "Not at all true" to 5 "Completely true," corresponding to the five stages of personal recovery. A score is calculated for each stage, ranging from 0 to 50
Time frame: Month 6
Stage of recovery instrument (STORI): a 50-item questionnaire that evaluates the five stages of personal recovery. Ten themes are assessed, each containing five items ranging from 0 "Not at all true" to 5 "Completely true," corresponding to the five stages of personal recovery. A score is calculated for each stage, ranging from 0 to 50
Time frame: Month 12
Stage of recovery instrument (STORI): a 50-item questionnaire that evaluates the five stages of personal recovery. Ten themes are assessed, each containing five items ranging from 0 "Not at all true" to 5 "Completely true," corresponding to the five stages of personal recovery. A score is calculated for each stage, ranging from 0 to 50
Time frame: Month 18
Stage of recovery instrument (STORI): a 50-item questionnaire that evaluates the five stages of personal recovery. Ten themes are assessed, each containing five items ranging from 0 "Not at all true" to 5 "Completely true," corresponding to the five stages of personal recovery. A score is calculated for each stage, ranging from 0 to 50
Time frame: Month 24
Stage of recovery instrument (STORI): a 50-item questionnaire that evaluates the five stages of personal recovery. Ten themes are assessed, each containing five items ranging from 0 "Not at all true" to 5 "Completely true," corresponding to the five stages of personal recovery. A score is calculated for each stage, ranging from 0 to 50
Time frame: Baseline (day 0)
Personal and social performance scale (PSP): measures four domains of social and individual functioning (socially useful activities, personal and social relationships, self-care, disruptive and aggressive behaviors) and provides a score between 1 and 100, divided into 10 equal intervals to assess the degree of difficulty. Higher scores correspond to better personal and social functioning, with scores of 91 to 100 indicating more than adequate functioning, while scores below 30 indicate such poor functioning that intensive supervision is required.
Time frame: Month 6
Personal and social performance scale (PSP): measures four domains of social and individual functioning (socially useful activities, personal and social relationships, self-care, disruptive and aggressive behaviors) and provides a score between 1 and 100, divided into 10 equal intervals to assess the degree of difficulty. Higher scores correspond to better personal and social functioning, with scores of 91 to 100 indicating more than adequate functioning, while scores below 30 indicate such poor functioning that intensive supervision is required.
Time frame: Month 12
Personal and social performance scale (PSP): measures four domains of social and individual functioning (socially useful activities, personal and social relationships, self-care, disruptive and aggressive behaviors) and provides a score between 1 and 100, divided into 10 equal intervals to assess the degree of difficulty. Higher scores correspond to better personal and social functioning, with scores of 91 to 100 indicating more than adequate functioning, while scores below 30 indicate such poor functioning that intensive supervision is required.
Time frame: Month 18
Personal and social performance scale (PSP): measures four domains of social and individual functioning (socially useful activities, personal and social relationships, self-care, disruptive and aggressive behaviors) and provides a score between 1 and 100, divided into 10 equal intervals to assess the degree of difficulty. Higher scores correspond to better personal and social functioning, with scores of 91 to 100 indicating more than adequate functioning, while scores below 30 indicate such poor functioning that intensive supervision is required.
Time frame: Month 24
Personal and social performance scale (PSP): measures four domains of social and individual functioning (socially useful activities, personal and social relationships, self-care, disruptive and aggressive behaviors) and provides a score between 1 and 100, divided into 10 equal intervals to assess the degree of difficulty. Higher scores correspond to better personal and social functioning, with scores of 91 to 100 indicating more than adequate functioning, while scores below 30 indicate such poor functioning that intensive supervision is required.
Time frame: Baseline (day 0)
Clinical global impression (CGI): a global observer-rated assessment tool that measures a patient's clinical condition before and after medical treatment. It consists of two measures: Severity, which measures the severity of the patient's clinical condition; and Improvement, which assesses the improvement in the patient's clinical condition since the start of treatment, both on a scale of 1 to 7.
Time frame: Month 6
Clinical global impression (CGI): a global observer-rated assessment tool that measures a patient's clinical condition before and after medical treatment. It consists of two measures: Severity, which measures the severity of the patient's clinical condition; and Improvement, which assesses the improvement in the patient's clinical condition since the start of treatment, both on a scale of 1 to 7.
Time frame: Month 12
Clinical global impression (CGI): a global observer-rated assessment tool that measures a patient's clinical condition before and after medical treatment. It consists of two measures: Severity, which measures the severity of the patient's clinical condition; and Improvement, which assesses the improvement in the patient's clinical condition since the start of treatment, both on a scale of 1 to 7.
Time frame: Month 18
Clinical global impression (CGI): a global observer-rated assessment tool that measures a patient's clinical condition before and after medical treatment. It consists of two measures: Severity, which measures the severity of the patient's clinical condition; and Improvement, which assesses the improvement in the patient's clinical condition since the start of treatment, both on a scale of 1 to 7.
Time frame: Month 24
Clinical global impression (CGI): a global observer-rated assessment tool that measures a patient's clinical condition before and after medical treatment. It consists of two measures: Severity, which measures the severity of the patient's clinical condition; and Improvement, which assesses the improvement in the patient's clinical condition since the start of treatment, both on a scale of 1 to 7.
Time frame: Baseline (day 0)
Birchwood insight scale (BIS); multidimensional assessment of awareness of illness (insight) and includes 8 questions (3-point Likert scale: "agree," "disagree," or "uncertain"). The overall score ranges from 0 to 12, with a score above 9 indicating good insight.
Time frame: Month 6
Birchwood insight scale (BIS); multidimensional assessment of awareness of illness (insight) and includes 8 questions (3-point Likert scale: "agree," "disagree," or "uncertain"). The overall score ranges from 0 to 12, with a score above 9 indicating good insight.
Time frame: Month 12
Birchwood insight scale (BIS); multidimensional assessment of awareness of illness (insight) and includes 8 questions (3-point Likert scale: "agree," "disagree," or "uncertain"). The overall score ranges from 0 to 12, with a score above 9 indicating good insight.
Time frame: Month 18
Birchwood insight scale (BIS); multidimensional assessment of awareness of illness (insight) and includes 8 questions (3-point Likert scale: "agree," "disagree," or "uncertain"). The overall score ranges from 0 to 12, with a score above 9 indicating good insight.
Time frame: Month 24
Birchwood insight scale (BIS); multidimensional assessment of awareness of illness (insight) and includes 8 questions (3-point Likert scale: "agree," "disagree," or "uncertain"). The overall score ranges from 0 to 12, with a score above 9 indicating good insight.
Time frame: Baseline (day 0)
Similarities section of the Wechsler Adult Intelligence Scale (WAIS): For 18 pairs of words, the participant subject must identify the qualitative relationship between the two words
Time frame: Month 6
Similarities section of the Wechsler Adult Intelligence Scale (WAIS): For 18 pairs of words, the participant subject must identify the qualitative relationship between the two words
Time frame: Month 12
Similarities section of the Wechsler Adult Intelligence Scale (WAIS): For 18 pairs of words, the participant subject must identify the qualitative relationship between the two words
Time frame: Month 18
Similarities section of the Wechsler Adult Intelligence Scale (WAIS): For 18 pairs of words, the participant subject must identify the qualitative relationship between the two words
Time frame: Month 24
Similarities section of the Wechsler Adult Intelligence Scale (WAIS): For 18 pairs of words, the participant subject must identify the qualitative relationship between the two words
Time frame: Baseline (day 0)
Matrix reasoning section of the Wechsler Adult Intelligence Scale (WAIS); in which participants must identify patterns in drawings
Time frame: Month 6
Matrix reasoning section of the Wechsler Adult Intelligence Scale (WAIS); in which participants must identify patterns in drawings
Time frame: Month 12
Matrix reasoning section of the Wechsler Adult Intelligence Scale (WAIS); in which participants must identify patterns in drawings
Time frame: Month 18
Matrix reasoning section of the Wechsler Adult Intelligence Scale (WAIS); in which participants must identify patterns in drawings
Time frame: Month 24
Matrix reasoning section of the Wechsler Adult Intelligence Scale (WAIS); in which participants must identify patterns in drawings
Time frame: Baseline (day 0)
Medication adherence rating scale (MARS): 10-item questionnaire concerning medication adherence during the past week assessing behaviors, attitudes, and experiences related to the treatment.
Time frame: Month 6
Medication adherence rating scale (MARS): 10-item questionnaire concerning medication adherence during the past week assessing behaviors, attitudes, and experiences related to the treatment.
Time frame: Month 12
Medication adherence rating scale (MARS): 10-item questionnaire concerning medication adherence during the past week assessing behaviors, attitudes, and experiences related to the treatment.
Time frame: Month 18
Medication adherence rating scale (MARS): 10-item questionnaire concerning medication adherence during the past week assessing behaviors, attitudes, and experiences related to the treatment.
Time frame: Month 24
Medication adherence rating scale (MARS): 10-item questionnaire concerning medication adherence during the past week assessing behaviors, attitudes, and experiences related to the treatment.
Time frame: Baseline (day 0)
California Verbal Learning Test--Second Edition (CVLT): in this word list recall and recognition test, the examiner reads a list of 16 nouns aloud at one-second intervals in a fixed order over five learning trials. The participant is asked to recall as many words as possible in any order (free recall). If subjects "cluster" words from each category, they are presumably using semantic organization. Free recall is tested immediately (short-term recall) and again after 20 minutes (long-term recall).
Time frame: Month 6
California Verbal Learning Test--Second Edition (CVLT): in this word list recall and recognition test, the examiner reads a list of 16 nouns aloud at one-second intervals in a fixed order over five learning trials. The participant is asked to recall as many words as possible in any order (free recall). If subjects "cluster" words from each category, they are presumably using semantic organization. Free recall is tested immediately (short-term recall) and again after 20 minutes (long-term recall).
Time frame: Month 12
California Verbal Learning Test--Second Edition (CVLT): in this word list recall and recognition test, the examiner reads a list of 16 nouns aloud at one-second intervals in a fixed order over five learning trials. The participant is asked to recall as many words as possible in any order (free recall). If subjects "cluster" words from each category, they are presumably using semantic organization. Free recall is tested immediately (short-term recall) and again after 20 minutes (long-term recall).
Time frame: Month 18
California Verbal Learning Test--Second Edition (CVLT): in this word list recall and recognition test, the examiner reads a list of 16 nouns aloud at one-second intervals in a fixed order over five learning trials. The participant is asked to recall as many words as possible in any order (free recall). If subjects "cluster" words from each category, they are presumably using semantic organization. Free recall is tested immediately (short-term recall) and again after 20 minutes (long-term recall).
Time frame: Month 24
California Verbal Learning Test--Second Edition (CVLT): in this word list recall and recognition test, the examiner reads a list of 16 nouns aloud at one-second intervals in a fixed order over five learning trials. The participant is asked to recall as many words as possible in any order (free recall). If subjects "cluster" words from each category, they are presumably using semantic organization. Free recall is tested immediately (short-term recall) and again after 20 minutes (long-term recall).
Contact information is provided by the study sponsor or research team.
Centre Hospitalier Universitaire de Nīmes
Other
Évaluation et évolution de l'identité Narrative et de Son Lien Avec le Bien-être Multidimensionnel Subjectif et le rétablissement Multidimensionnel Dans le Premier épisode Psychotique
Acronym: PEPID
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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