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/NCT06036004</url>
    </required_header>
    <id_info>
      <org_study_id>2023-01010; kt22ChristCrain</org_study_id>
      <nct_id>NCT06036004</nct_id>
    </id_info>
    <brief_title>Oxytocin Substitution Therapy in Patients With Central Diabetes Insipidus</brief_title>
    <acronym>OxyTUTION</acronym>
    <official_title>Oxytocin Substitution Therapy in Patients With Central Diabetes Insipidus: a Double-blind Randomised Placebo-controlled Trial: the OxyTUTION Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Basel, Switzerland</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital, Basel, Switzerland</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 randomized, placebo-controlled, double-blind trial aims to investigate intranasal OXT as&#xD;
        a novel therapeutical option in central diabetes insipidus (cDI) to improve psychological&#xD;
        symptoms and socio-emotional functioning.&#xD;
  &#xD;
        Optionally, patients can present for additional assessments in sub-studies:&#xD;
  &#xD;
          -  fMRI sub-study at day 14 (± 2 days) (one additional visit)&#xD;
  &#xD;
          -  Social-stress sub-study at day 14 (± 2 days) (one additional visit)&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Arginine vasopressin (AVP) and oxytocin (OXT) are hormones released into circulation from the&#xD;
        posterior pituitary. While AVP acts mainly in the kidneys and causes reuptake of free water,&#xD;
        OXT is well-known for its key role in the regulation of complex social-emotional functioning&#xD;
        including attachment and pair bonding, fear possessing, emotion recognition, and empathy.&#xD;
  &#xD;
        Disruption of the hypothalamic-pituitary axis can cause AVP deficiency&#xD;
  &#xD;
        - known as central diabetes insipidus (cDI) - characterized by polyuria and polydipsia. Once&#xD;
        diagnosed, desmopressin (an AVP receptor analogue) can be effectively used to treat diabetes&#xD;
        insipidus. However, despite treatment with desmopressin, patients often report residual&#xD;
        psychological symptoms, particularly heightened anxiety levels, depressed mood, impairment in&#xD;
        social interactions, leading to an overall reduced quality of life.&#xD;
  &#xD;
        Due to the anatomical proximity, local disruptions of the AVP system could also disturb the&#xD;
        OXT system leading to an additional OXT deficiency. The additional OXT deficiency could&#xD;
        explain (at least partially) the residual psychological deficits in patients with cDI. OXT&#xD;
        replacement therapy to improve psychological symptoms would have great clinical implications.&#xD;
        This randomized, placebo-controlled, double-blind trial aims to investigate intranasal OXT as&#xD;
        a novel therapeutical option in cDI to improve psychological symptoms and socio-emotional&#xD;
        functioning.&#xD;
  &#xD;
        Optional fMRI sub-study: Participants will undergo a structural sequence to investigate grey&#xD;
        and white matter anatomy (T1- weighted). Functional neuronal responses will be assessed&#xD;
        through the surrogate of blood oxygenated level dependent (BOLD) signal, an indirect measure&#xD;
        of neural activity. Three functional sequences (echo planar imaging, EPI) will investigate&#xD;
        group differences in various aspects of brain activity: a resting state sequence and the&#xD;
        EFMT.&#xD;
  &#xD;
        Optional Social-stress sub-study: The three main components are an anticipation phase, a&#xD;
        5-minute interview, and a surprise mental arithmetic task. Acute stress is measured by&#xD;
        cortisol increase.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">October 2026</completion_date>
    <primary_completion_date type="Anticipated">October 2026</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>double-blind randomised placebo-controlled trial: participants will be randomly assigned 1:1 to receive either treatment with intranasal OXT or intranasal placebo</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
      <masking_description>Study participants, study team (i.e., study nurses, study physicians, study psychologists), and further outcome assessors will be blinded after assignment to interventions.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Change in State-Trait Anxiety Inventory (STAI) questionnaire to assess general anxiety levels</measure>
      <time_frame>Day 0, day 1, day 14, day 28</time_frame>
      <description>Questionnaire with scores ranging from 1 (&quot;almost never&quot;) to 4 (&quot;almost always&quot;). The STAI has two sub-scales, the State-Anxiety Scale (STAI-S; 20 items) and the Trait-Anxiety Scale (STAI-T; 20 items). The STAI-S evaluates the current state of anxiety, asking how respondents feel &quot;right now,&quot; using items that measure subjective feelings of apprehension, tension, nervousness, worry, and activation/arousal of the autonomic nervous system. The STAI-T evaluates relatively stable aspects of &quot;anxiety proneness,&quot; including general states of calmness, confidence, and security. The total scores range from 20 to 80, with higher scores indicating more pronounced anxiety. A score above 39/80 indicates clinically significant anxiety symptoms.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in EmBody/EmFace to assess recognition of facial and body expressions</measure>
      <time_frame>Day 0, day 1, day 28</time_frame>
      <description>The EmBody and EmFace subtasks comprise each of 42 stimuli showing body or facial expressions of angry, happy, or neutral affect. Stimuli last 1.5 seconds at 24 frames per second and are geometrically and optically standardised to prevent biases induced by ethnic cues. Each trial consists of one point-light display (PLD), followed by a response window during which participants are asked to indicate via mouse input which emotion they believe was portrayed in the PLD in a three-option forced-choice format (angry-neutral-happy). The total correct classification scores range from 0 to 42 (for each sub-task), with higher scores indicating more correct recognition of facial &amp; body expressions.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in Facial emotion recognition task (FERT) to assess emotion recognition and empathy</measure>
      <time_frame>Day 0, day 28</time_frame>
      <description>The FERT assesses the recognition of basic emotions. The task includes ten neutral faces and 160 faces that express one of four basic emotions (i.e., happiness, sadness, anger, and fear), with pictures morphed between 0% (i.e., neutral) and 100% in 10% steps. Stimuli are shown in random order for 500 ms, followed by the rating screen, where participants have to indicate the correct emotion. The outcome measure is accuracy (proportion correct).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Multifaceted Empathy Test (MET) to assess the cognitive and emotional aspects of empathy</measure>
      <time_frame>Day 0, day 1, day 28</time_frame>
      <description>The computer-assisted test consists of 40 photographs that showed people in emotionally charged situations. To assess cognitive empathy, the participants are required to infer the mental state of the subject in each scene and indicate the correct mental state from a list of four responses. Cognitive empathy is the percentage of correct responses in the total responses. To measure emotional empathy, the subjects are asked to rate how much they feel for an individual in each scene (i.e., explicit emotional empathy) and how much they are aroused by each scene (i.e., implicit emotional empathy) on a 1-9 point scale.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Hamilton Anxiety Rating Scale (HAM) to assess the severity of anxiety symptoms</measure>
      <time_frame>Day 0, day 28</time_frame>
      <description>The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). The physician/psychologist is instructed to assess the extent to which the patient displays the given criterion. Each item is independently scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56 (&lt;17 indicates mild severity, 18-24 mild to moderate severity, and 25-30 moderate to severe).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Toronto Alexithymia Scale 20 (TAS-20) to assess emotions experienced by oneself or others</measure>
      <time_frame>Day 0, day 28</time_frame>
      <description>The TAS 20 has a three- factor structure: difficulty identifying and describing feelings and externally oriented thinking. It includes 20 items with scores ranging from 1 (strongly disagree) to 5 (strongly agree). The total scores range from 20 to 100, with higher scores indicating worse alexithymia. A score of ≥61 indicates alexithymia (difficulty understanding one's emotions), a score of 52 to 60 indicates possible alexithymia, and a ≤51 non-alexithymia.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Autism-Spectrum Quotient Test (AQ) to assess the expression of ASD traits in an individual by his or her subjective self-assessment</measure>
      <time_frame>Day 0, day 28</time_frame>
      <description>The AQ consists of 50 items, with four choices for each item from &quot;definitely agree&quot; to &quot;definitely disagree&quot; and a total score from 0 to 50. A score above the proposed cut-off of 29 highlights significant traits of autism</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Beck's Depression Inventory II (BDI-II) to assess depression</measure>
      <time_frame>Day 0, day 28</time_frame>
      <description>It uses 21 items ranked from 0 (symptom absent) to 3 (severe symptoms) to measure the severity of depression. The minimum score is 0, and the maximum score is 63. In non-clinical populations, scores above 20 indicate depression. In those diagnosed with depression, the score ≤16, mild mood disturbance; 17 to 20, borderline clinical depression, 21 to 30, moderate depression, and score ≥31, severe depression.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Change in Close third-person assessment</measure>
      <time_frame>Day 0, day 28</time_frame>
      <description>A telephone interview with a close third individual can be conducted to provide a subjective assessment at the beginning and the end of the treatment phase. Assessment will be done by rating 10 socio-emotional items such as &quot;closeness to others,&quot; &quot;anxious behaviour daily life,&quot; &quot;empathic feeling,&quot; etc., by using unidirectional 100-point or bidirectional -50/+50-point visual analogue scales.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">112</enrollment>
    <condition>Central Diabetes Insipidus (cDI)</condition>
    <arm_group>
      <arm_group_label>Study Product Intervention: intranasal OXT</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Intranasal OXT spray of 40 IU per ml (Syntocinon®).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Intervention: placebo nasal spray</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>The placebo nasal spray will be identical in volume, labelling, container system, and other features.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Intranasal OXT</intervention_name>
      <description>Syntocinon® contains the synthesized peptide OXT in a solution formulated to promote absorption through the nasal mucosa. Additional ingredients are E216 (propyl-4-hydroxybenzoate), E218 (methyl-4-hydroxybenzoate), and chlorobutanol hemihydrate. One bottle contains 5 ml, i.e., 200 IU of OXT in total. Each 0.1 ml nasal insulation delivers 4 IU of oxytocin.&#xD;
  OXT (24 IU twice daily) is given for 28 (± 2) days of treatment.</description>
      <arm_group_label>Study Product Intervention: intranasal OXT</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Placebo nasal spray</intervention_name>
      <description>The placebo will contain no OXT but, otherwise, be identical to the intranasal OXT product with respect to the other ingredients.&#xD;
  Placebo is given twice daily for 28 (± 2) days of treatment.</description>
      <arm_group_label>Control Intervention: placebo nasal spray</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult patients with a confirmed diagnosis of central diabetes insipidus based on&#xD;
               accepted criteria&#xD;
  &#xD;
            -  Heightened anxiety levels (STAI - Trait subscale ≥ 39 score points) or alexithymia&#xD;
               levels (impaired ability to identify and describe feelings; TAS-20 total ≥ 52 score&#xD;
               points)&#xD;
  &#xD;
            -  Stable hormone replacement therapy for at least three months with desmopressin and, in&#xD;
               case of additional anterior pituitary deficiencies, with the respective substitution&#xD;
               therapies.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Participation in a trial with investigational drugs within 30 days&#xD;
  &#xD;
            -  Active substance use disorder within the last six months&#xD;
  &#xD;
            -  Consumption of alcoholic beverages &gt;15 drinks/week&#xD;
  &#xD;
            -  Current or previous psychotic disorder (e.g., schizophrenia spectrum disorder)&#xD;
  &#xD;
            -  Pregnancy and breastfeeding within the last eight weeks&#xD;
  &#xD;
            -  Unwilling to use a medically acceptable form of contraception throughout the study&#xD;
               period (female of childbearing potential only)&#xD;
  &#xD;
            -  Prolonged QTc-time &gt;470 ms assessed with a 12-lead electrocardiogram.&#xD;
  &#xD;
            -  Regular use (&gt; 3 times per week) of sympathomimetic drugs (e.g., bronchodilators)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mirjam Christ-Crain, Prof. Dr. med.</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Hospital Basel, Department of Endocrinology, Diabetes &amp; Metabolism</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Mirjam Christ-Crain, Prof. Dr. med.</last_name>
      <phone>+41 61 328 70 80</phone>
      <email>mirjam.christ-crain@ubs.ch</email>
    </overall_contact>
    <location>
      <facility>
        <name>University Hospital Basel, Department of Endocrinology, Diabetes &amp; Metabolism</name>
        <address>
          <city>Basel</city>
          <zip>4031</zip>
          <country>Switzerland</country>
        </address>
      </facility>
      <contact>
        <last_name>Mirjam Christ-Crain, Prof. Dr. med.</last_name>
        <phone>+41 61 328 70 80</phone>
        <email>mirjam.christ-crain@ubs.ch</email>
      </contact>
      <investigator>
        <last_name>Mirjam Christ-Crain, Prof. Dr. med.</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Cihan Atila, Dr. med.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Svenja Leibnitz, Dr. med.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Dominique de Quervain, Prof. Dr. med.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Matthias Liechti, Prof. Dr. med.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Switzerland</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 6, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 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>
    <keyword>oxytocin (OXT)</keyword>
    <keyword>hypothalamic-pituitary axis</keyword>
    <keyword>Arginine vasopressin (AVP)</keyword>
    <keyword>OXT deficiency</keyword>
    <keyword>socio-emotional functioning</keyword>
    <keyword>intranasal OXT</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Diabetes Insipidus</mesh_term>
      <mesh_term>Diabetes Insipidus, Neurogenic</mesh_term>
      <mesh_term>Diabetes Mellitus</mesh_term>
    </condition_browse>
    <!-- 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/NCT06036004
  org study id: 2023-01010; kt22ChristCrain
  nct id: NCT06036004
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This randomized, placebo-controlled, double-blind trial aims to investigate intranasal OXT as
        a novel therapeutical option in central diabetes insipidus (cDI) to improve psychological
        symptoms and socio-emotional functioning.
  
        Optionally, patients can present for additional assessments in sub-studies:
  
          -  fMRI sub-study at day 14 (± 2 days) (one additional visit)
  
          -  Social-stress sub-study at day 14 (± 2 days) (one additional visit)
  Arginine vasopressin (AVP) and oxytocin (OXT) are hormones released into circulation from the
        posterior pituitary. While AVP acts mainly in the kidneys and causes reuptake of free water,
        OXT is well-known for its key role in the regulation of complex social-emotional functioning
        including attachment and pair bonding, fear possessing, emotion recognition, and empathy.
  
        Disruption of the hypothalamic-pituitary axis can cause AVP deficiency
  
        - known as central diabetes insipidus (cDI) - characterized by polyuria and polydipsia. Once
        diagnosed, desmopressin (an AVP receptor analogue) can be effectively used to treat diabetes
        insipidus. However, despite treatment with desmopressin, patients often report residual
        psychological symptoms, particularly heightened anxiety levels, depressed mood, impairment in
        social interactions, leading to an overall reduced quality of life.
  
        Due to the anatomical proximity, local disruptions of the AVP system could also disturb the
        OXT system leading to an additional OXT deficiency. The additional OXT deficiency could
        explain (at least partially) the residual psychological deficits in patients with cDI. OXT
        replacement therapy to improve psychological symptoms would have great clinical implications.
        This randomized, placebo-controlled, double-blind trial aims to investigate intranasal OXT as
        a novel therapeutical option in cDI to improve psychological symptoms and socio-emotional
        functioning.
  
        Optional fMRI sub-study: Participants will undergo a structural sequence to investigate grey
        and white matter anatomy (T1- weighted). Functional neuronal responses will be assessed
        through the surrogate of blood oxygenated level dependent (BOLD) signal, an indirect measure
        of neural activity. Three functional sequences (echo planar imaging, EPI) will investigate
        group differences in various aspects of brain activity: a resting state sequence and the
        EFMT.
  
        Optional Social-stress sub-study: The three main components are an anticipation phase, a
        5-minute interview, and a surprise mental arithmetic task. Acute stress is measured by
        cortisol increase.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: double-blind randomised placebo-controlled trial: participants will be randomly assigned 1:1 to receive either treatment with intranasal OXT or intranasal placebo
  primary purpose: Treatment
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  masking description: Study participants, study team (i.e., study nurses, study physicians, study psychologists), and further outcome assessors will be blinded after assignment to interventions.
  measure: Change in State-Trait Anxiety Inventory (STAI) questionnaire to assess general anxiety levels
  time frame: Day 0, day 1, day 14, day 28
  description: Questionnaire with scores ranging from 1 ("almost never") to 4 ("almost always"). The STAI has two sub-scales, the State-Anxiety Scale (STAI-S; 20 items) and the Trait-Anxiety Scale (STAI-T; 20 items). The STAI-S evaluates the current state of anxiety, asking how respondents feel "right now," using items that measure subjective feelings of apprehension, tension, nervousness, worry, and activation/arousal of the autonomic nervous system. The STAI-T evaluates relatively stable aspects of "anxiety proneness," including general states of calmness, confidence, and security. The total scores range from 20 to 80, with higher scores indicating more pronounced anxiety. A score above 39/80 indicates clinically significant anxiety symptoms.
  measure: Change in EmBody/EmFace to assess recognition of facial and body expressions
  time frame: Day 0, day 1, day 28
  description: The EmBody and EmFace subtasks comprise each of 42 stimuli showing body or facial expressions of angry, happy, or neutral affect. Stimuli last 1.5 seconds at 24 frames per second and are geometrically and optically standardised to prevent biases induced by ethnic cues. Each trial consists of one point-light display (PLD), followed by a response window during which participants are asked to indicate via mouse input which emotion they believe was portrayed in the PLD in a three-option forced-choice format (angry-neutral-happy). The total correct classification scores range from 0 to 42 (for each sub-task), with higher scores indicating more correct recognition of facial & body expressions.
  measure: Change in Facial emotion recognition task (FERT) to assess emotion recognition and empathy
  time frame: Day 0, day 28
  description: The FERT assesses the recognition of basic emotions. The task includes ten neutral faces and 160 faces that express one of four basic emotions (i.e., happiness, sadness, anger, and fear), with pictures morphed between 0% (i.e., neutral) and 100% in 10% steps. Stimuli are shown in random order for 500 ms, followed by the rating screen, where participants have to indicate the correct emotion. The outcome measure is accuracy (proportion correct).
  measure: Change in Multifaceted Empathy Test (MET) to assess the cognitive and emotional aspects of empathy
  time frame: Day 0, day 1, day 28
  description: The computer-assisted test consists of 40 photographs that showed people in emotionally charged situations. To assess cognitive empathy, the participants are required to infer the mental state of the subject in each scene and indicate the correct mental state from a list of four responses. Cognitive empathy is the percentage of correct responses in the total responses. To measure emotional empathy, the subjects are asked to rate how much they feel for an individual in each scene (i.e., explicit emotional empathy) and how much they are aroused by each scene (i.e., implicit emotional empathy) on a 1-9 point scale.
  measure: Change in Hamilton Anxiety Rating Scale (HAM) to assess the severity of anxiety symptoms
  time frame: Day 0, day 28
  description: The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). The physician/psychologist is instructed to assess the extent to which the patient displays the given criterion. Each item is independently scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56 (<17 indicates mild severity, 18-24 mild to moderate severity, and 25-30 moderate to severe).
  measure: Change in Toronto Alexithymia Scale 20 (TAS-20) to assess emotions experienced by oneself or others
  time frame: Day 0, day 28
  description: The TAS 20 has a three- factor structure: difficulty identifying and describing feelings and externally oriented thinking. It includes 20 items with scores ranging from 1 (strongly disagree) to 5 (strongly agree). The total scores range from 20 to 100, with higher scores indicating worse alexithymia. A score of ≥61 indicates alexithymia (difficulty understanding one's emotions), a score of 52 to 60 indicates possible alexithymia, and a ≤51 non-alexithymia.
  measure: Change in Autism-Spectrum Quotient Test (AQ) to assess the expression of ASD traits in an individual by his or her subjective self-assessment
  time frame: Day 0, day 28
  description: The AQ consists of 50 items, with four choices for each item from "definitely agree" to "definitely disagree" and a total score from 0 to 50. A score above the proposed cut-off of 29 highlights significant traits of autism
  measure: Change in Beck's Depression Inventory II (BDI-II) to assess depression
  time frame: Day 0, day 28
  description: It uses 21 items ranked from 0 (symptom absent) to 3 (severe symptoms) to measure the severity of depression. The minimum score is 0, and the maximum score is 63. In non-clinical populations, scores above 20 indicate depression. In those diagnosed with depression, the score ≤16, mild mood disturbance; 17 to 20, borderline clinical depression, 21 to 30, moderate depression, and score ≥31, severe depression.
  measure: Change in Close third-person assessment
  time frame: Day 0, day 28
  description: A telephone interview with a close third individual can be conducted to provide a subjective assessment at the beginning and the end of the treatment phase. Assessment will be done by rating 10 socio-emotional items such as "closeness to others," "anxious behaviour daily life," "empathic feeling," etc., by using unidirectional 100-point or bidirectional -50/+50-point visual analogue scales.
  arm group label: Study Product Intervention: intranasal OXT
  arm group type: Active Comparator
  description: Intranasal OXT spray of 40 IU per ml (Syntocinon®).
  arm group label: Control Intervention: placebo nasal spray
  arm group type: Placebo Comparator
  description: The placebo nasal spray will be identical in volume, labelling, container system, and other features.
  intervention type: Drug
  intervention name: Intranasal OXT
  description: Syntocinon® contains the synthesized peptide OXT in a solution formulated to promote absorption through the nasal mucosa. Additional ingredients are E216 (propyl-4-hydroxybenzoate), E218 (methyl-4-hydroxybenzoate), and chlorobutanol hemihydrate. One bottle contains 5 ml, i.e., 200 IU of OXT in total. Each 0.1 ml nasal insulation delivers 4 IU of oxytocin.
  OXT (24 IU twice daily) is given for 28 (± 2) days of treatment.
  arm group label: Study Product Intervention: intranasal OXT
  intervention type: Other
  intervention name: Placebo nasal spray
  description: The placebo will contain no OXT but, otherwise, be identical to the intranasal OXT product with respect to the other ingredients.
  Placebo is given twice daily for 28 (± 2) days of treatment.
  arm group label: Control Intervention: placebo nasal spray
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Mirjam Christ-Crain, Prof. Dr. med.
  role: Principal Investigator
  affiliation: University Hospital Basel, Department of Endocrinology, Diabetes & Metabolism
  last name: Mirjam Christ-Crain, Prof. Dr. med.
  phone: +41 61 328 70 80
  email: mirjam.christ-crain@ubs.ch
  facility: 
  contact: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: Switzerland
  responsible party type: Sponsor
  mesh term: Diabetes Insipidus
  mesh term: Diabetes Insipidus, Neurogenic
  mesh term: Diabetes Mellitus