<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/NCT03831646</url>
  </required_header>
  <id_info>
    <org_study_id>4</org_study_id>
    <nct_id>NCT03831646</nct_id>
  </id_info>
  <brief_title>Clinical, Psychological and Genetic Characteristics in Dermatological Patients</brief_title>
  <official_title>Clinical, Psychological and Genetic Characteristics of Patients With Atopic Dermatitis and Psoriasis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Astana Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ariel University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tirat Carmel Mental Health Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Medical Centre Hospital of the President's Affairs Administration, Republic of Kazakhstan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Astana Medical University</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>
      Atopic dermatitis (AD) and psoriasis (PS) are chronic, relapsing dermatological disorders&#xD;
      with a high rate of psychiatric co-morbid pathology represented with depression. Brain&#xD;
      Derived Neurotrophic Factor (BDNF) belongs to the neurotrophin family and widely studied in&#xD;
      pathophysiology of psychiatric and dermatological disorders. A biological stress response&#xD;
      system by altered hypothalamic-pituitary-adrenal (HPA) axis as well&#xD;
      hypothalamic-pituitary-gonadal (HPG) axis may contribute to dermatoses and psychiatric&#xD;
      disorders development. Various factors including gender, genetic, psychological stress,&#xD;
      socioeconomic factors also affect the course of dermatoses.&#xD;
&#xD;
      A 10-week, case-control study evaluate clinical, psychological and biochemical parameters in&#xD;
      AD and PS patients, and healthy control volunteers (HC) depending on gender and BDNF rs6265&#xD;
      gene polymorphism. All parameters are evaluated twice: at disease exacerbation (study&#xD;
      baseline) and week 10.&#xD;
&#xD;
      The following methods are conducted: assessment of dermatological status, using Scoring of&#xD;
      Atopic Dermatitis (SCORAD) and Psoriasis Area and Severity Index (PASI); assessment of&#xD;
      depression and anxiety according to DSM-V criteria and with Hamilton Depression Rating Scale&#xD;
      (HAM-D) and with Hamilton Anxiety Rating Scale (HAM-A); analysis of serum BDNF (ng/ml),&#xD;
      cortisol (nmol/L), testosterone (ng/dL) and IgE levels (IU/ml, AD only); DNA extraction and&#xD;
      genotyping of BDNF variants.The study will last during 4-5 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Atopic dermatitis (AD) and psoriasis (PS) are related to psychodermatological disorders with&#xD;
      chronic relapsing course, multifactorial etiology and complex pathogenesis. In accordance&#xD;
      with DSM-V, AD and PS belong to psychosomatic disorders with psychogenic manifestation and&#xD;
      exacerbation, whereas depression represents a high range of psychiatric co-morbid pathology&#xD;
      in AD and PS patients. Brain Derived Neurotrophic Factor (BDNF) is a prominent representative&#xD;
      of the neurotrophins family, widely studied in pathophysiology of psychiatric and&#xD;
      dermatological disorders. Various factors including ethnicity, gender, genetic and&#xD;
      socioeconomic causes as well methods of diagnosis and case definition may affect the course&#xD;
      of dermatoses. A possible mechanism that contributes to dermatitis and psychiatric disorders&#xD;
      development is dysregulation of the biological stress response system by altered&#xD;
      hypothalamic-pituitary-adrenal (HPA) axis functioning. In addition many studies emphasize the&#xD;
      role of gonadal hormones both in depression and dermatoses.&#xD;
&#xD;
      This study evaluate clinical, psychological and biochemical parameters in AD and PS patients&#xD;
      depending on gender and BDNF rs6265 gene polymorphism. Investigators conduct a 10-week,&#xD;
      case-control study among AD and PS patients and healthy controls (HC) volunteers. All&#xD;
      parameters are evaluated twice: at disease exacerbation (study baseline) and week 10.&#xD;
&#xD;
      The following methods are used: assessment of dermatological status, using Scoring of Atopic&#xD;
      Dermatitis (SCORAD) and Psoriasis Area and Severity Index (PASI); assessment of depression&#xD;
      and anxiety according to DSM-V criteria and with Hamilton Depression Rating Scale (HAM-D) and&#xD;
      Hamilton Anxiety Rating Scale (HAM-A); analysis of serum BDNF (ng/ml), cortisol (nmol/L),&#xD;
      testosterone (ng/dL) and IgE levels (IU/ml, AD only); DNA extraction and genotyping of BDNF&#xD;
      variants.&#xD;
&#xD;
      Sample collection and processing: blood are taken between 8-10 a.m. to prevent daily&#xD;
      variations on week 0 and week 10 and collected to serum-separation tubes (SST) and EDTA tubes&#xD;
      (for DNA extraction); samples are cooled (1 hr, 4°C) and centrifuged (2000xg, 10 minutes,&#xD;
      25°C); serum are stored at -20°C before analysis; DNA extraction from whole blood is&#xD;
      performed≤3 days from collection and stored (-70°C).&#xD;
&#xD;
      After written informed consent and first blood sample, patients are provided with&#xD;
      conventional treatments. For AD this include antihistamines (e.g., diphenhydramine,&#xD;
      desloratadine), topical corticosteroids (e.g., betamethasone, mometasone) up to 3 weeks and&#xD;
      emollients up to 2 months; for PS we will prescribe antihistamines (e.g., diphenhydramine,&#xD;
      desloratadine), topical corticosteroids (e.g., betamethasone, mometasone) up to 3 weeks and&#xD;
      keratolytics (2% salicylic ointment) up to 2 weeks. Patients are not prescribed&#xD;
      antidepressants and other psychotropic agents.&#xD;
&#xD;
      For assessment of study parameters all patients and HC will be divided into subgroups&#xD;
      according to gender (males, femaes) and BDNF gene polymorphism (Val/Val; Val/Met; Met/Met).&#xD;
      Additionally AD patients will be divided by IgE sensitization: EAD (extrinsic, IgE sensitive)&#xD;
      and IAD (intrinsic, IgE non-sensitive).&#xD;
&#xD;
      The study will last for 4-5 months. Patients inclusion criteria: no pregnancy; no unstable&#xD;
      non-dermatological medical conditions, no systemic therapy (glucocorticosteroids,&#xD;
      immunosuppressants and psychotropic drugs) within the month prior the study and blood&#xD;
      sampling, no history of mental or other dermatological disorders, no severe forms of AD and&#xD;
      PS; good general physical health. Inclusion criteria for HC are no pregnancy and good general&#xD;
      physical health.&#xD;
&#xD;
      Statistics will be performed using unpaired t-test or paired t-test (week 0: week 10&#xD;
      comparisons, verified by Pearson/Spearman correlation). Unpaired, one-way ANOVA and/or&#xD;
      two-way ANOVA test will be used for multiple group comparisons. Data will be presented as&#xD;
      mean±SEM.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 20, 2019</start_date>
  <completion_date type="Actual">July 30, 2019</completion_date>
  <primary_completion_date type="Actual">July 10, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of change in the severity of atopic dermatitis after conventional treatment from study onset (baseline) at week 10</measure>
    <time_frame>At disease onset (study baseline) and at week 10</time_frame>
    <description>Assessment of atopic dermatitis severity is conducted using Scoring of Atopic Dermatitis (SCORAD) index. SCORAD index formula is: A/5 + 7B/2 + C. In this formula A is defined as the extent (0-100), B is defined as the intensity (0-18) and C is defined as the subjective symptoms (0-20). The maximum SCORAD score is 103. SCORAD &lt;23 - mild AD; SCORAD from 23 to 63 - moderate AD; SCORAD&gt; 63 - severe AD.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of change in the severity of psoriasis after conventional treatment from study onset (baseline) at week 10</measure>
    <time_frame>At disease onset (study baseline) and at week 10</time_frame>
    <description>Assessment of the psoriasis severity is conducted using Psoriasis Area and Severity Index (PASI). The patient's body is divided into four sections (head (H) (10% of a person's skin); arms (A) (20%); trunk (T) (30%); legs (L) (40%)). The percent of skin lesions of each area is assessed as follows: 0 (0% of involved area); 1 (&lt; 10%); 2 (10-29%); 3 (30-49%); 4 (50-69%); 5 (70-89%); 6 (90-100%). Further, for each region, the intensity of 3 clinical signs is evaluated - redness, thickness and scaling and assessed as follows: 0 - no lesions,1 - easy, 2 - moderate, 3 - severe, 4 - very severe. The sum of all three severity parameters is calculated for each section, multiplied by the area score for that area and multiplied by weight of respective section (0.1 for head, 0.2 for arms, 0.3 for body, 0.4 for legs). PASI range is from 0 (no disease) to 72 (maximum disease). The severity of psoriasis is assessed as follows: PASI &lt;20 - mild; PASI from 20 to 50 - moderate; PASI&gt; 50 - severe</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of change in the severity of depression in atopic dermatitis and psoriasis patients after conventional treatment from study onset (baseline) at week 10</measure>
    <time_frame>At disease onset (study baseline) and week 10</time_frame>
    <description>Depression is assessed according to Diagnostic and Statistical Manual of Mental Disorders (DSM) -V criteria and with Hamilton Depression Rating Scale (HAM-D) using the following ranges: absence, ≤7; mild, 8-16; moderate, 17-27; severe, ≤28</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of the severity of depression in healthy controls (HC)</measure>
    <time_frame>At disease onset (study baseline)</time_frame>
    <description>Depression is assessed according to Diagnostic and Statistical Manual of Mental Disorders (DSM) -V criteria and with Hamilton Depression Rating Scale (HAM-D) using the following ranges: absence, ≤7; mild, 8-16; moderate, 17-27; severe, ≤28</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of change in the severity of anxiety in atopic dermatitis and psoriasis patients after conventional treatment from study onset (baseline) at week 10</measure>
    <time_frame>At disease onset (study baseline) and week 10</time_frame>
    <description>Anxiety is assessed according to Diagnostic and Statistical Manual of Mental Disorders (DSM) -V criteria and with Hamilton Anxiety Rating Scale (HAM-A) using the following ranges: ≤17, easy; 18-24, moderate; over 25, medium-severe</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of the severity of anxiety in HC</measure>
    <time_frame>At disease onset (study baseline)</time_frame>
    <description>Anxiety is assessed according to Diagnostic and Statistical Manual of Mental Disorders (DSM) -V criteria and with Hamilton Anxiety Rating Scale (HAM-A) using the following ranges: ≤17, easy; 18-24, moderate; over 25, medium-severe</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of changes in serum immunoglobulin E (IgE, IU/ml) levels from study onset (baseline) at week 10 in atopic dermatitis patients</measure>
    <time_frame>At disease onset (study baseline) and week 10</time_frame>
    <description>The total IgE levels are detected using solid-phase, chemiluminescent immunometric assay in an Immulite/Immulite 1000 (Siemens, Germany). Normal ranges are as follow: 0.000-100.0 IU/ml</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Analysis of serum IgE (IU/ml) levels in HC</measure>
    <time_frame>At disease onset (study baseline)</time_frame>
    <description>The total IgE levels are detected using solid-phase, chemiluminescent immunometric assay in an Immulite/Immulite 1000 (Siemens, Germany). Normal ranges are as follow: 0.000-100.0 IU/ml</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of changes in serum Brain Derived Neurotrophic Factor (BDNF, ng/ml) levels from study onset (baseline) at week 10 in atopic dermatitis and psoriasis patients</measure>
    <time_frame>At disease onset (study baseline) and week 10</time_frame>
    <description>Serum BDNF levels are analyzed using a solid-phase, sandwich, two-site, ELISA (Promega, US; G7610). No measurement scale is used</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Analysis of serum BDNF (ng/ml) levels in HC</measure>
    <time_frame>At disease onset (study baseline)</time_frame>
    <description>Serum BDNF levels are analyzed using a solid-phase, sandwich, two-site, ELISA (Promega, US; G7610). No measurement scale is used</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of changes in cortisol (nmol/L) levels from study onset (baseline) at week 10 in atopic dermatitis and psoriasis patients</measure>
    <time_frame>At disease onset (study baseline) and week 10</time_frame>
    <description>The total cortisol levels are detected using solid-phase, chemiluminescent immunometric assay in an Immulite/Immulite 1000 (Siemens, Germany). Normal ranges are as follow: 138-690 nmol/L</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Analysis of serum cortisol (nmol/L) levels in HC</measure>
    <time_frame>At disease onset (study baseline)</time_frame>
    <description>The total cortisol levels are detected using solid-phase, chemiluminescent immunometric assay in an Immulite/Immulite 1000 (Siemens, Germany). Normal ranges are as follow: 138-690 nmol/L</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of changes in testosterone (ng/dL) levels from study onset (baseline) at week 10 in atopic dermatitis and psoriasis patients</measure>
    <time_frame>At disease onset (study baseline) and week 10</time_frame>
    <description>The total testosterone levels are detected using solid-phase, chemiluminescent immunometric assay in an Immulite/Immulite 1000 (Siemens, Germany). Normal ranges are as follow: men 20-49 years - 72 -853ng/dL; men≥50 years -129-767 ng/dL; women ovulating - 0.010-73.0 ng/dL; women postmenopausal - 0.010-43.0 ng/dL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Analysis of serum testosterone (ng/dL) levels in HC</measure>
    <time_frame>At disease onset (study baseline)</time_frame>
    <description>The total testosterone levels are detected using solid-phase, chemiluminescent immunometric assay in an Immulite/Immulite 1000 (Siemens, Germany). Normal ranges are as follow: men 20-49 years - 72 -853ng/dL; men≥50 years -129-767 ng/dL; women ovulating - 0.010-73.0 ng/dL; women postmenopausal - 0.010-43.0 ng/dL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>DNA extraction in AD, PS and HC</measure>
    <time_frame>At disease onset (study baseline)</time_frame>
    <description>DNA extraction and genotyping the BDNF rs6265 (Val66Met) gene polymorphism in AD, PS and HC</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment and comparison (Unpaired t-test) of SCORAD scores in extrinsic atopic dermatitis (EAD, IgE level above the normal) and intrinsic atopic dermatitis (IAD, normal IgE level) patients compared with baseline after conventional treatment at week 10</measure>
    <time_frame>At disease onset (study baseline) and week 10</time_frame>
    <description>EAD and IAD patients will be divided into subgroups in accordance with BDNF gene polymorphism and gender with following assessment of SCORAD scores compared with baseline after conventional treatment at week 10 in each group using unpaired t-test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment and comparison (Unpaired t-test) of PASI scores in psoriasis patients compared with baseline after conventional treatment at week 10 in accordance with BDNF gene polymorphism (Val/Val; Val/Met;Met/Met) and gender(males, females)</measure>
    <time_frame>At disease onset (study baseline) and week 10</time_frame>
    <description>Psoriasis patients will be divided into subgroups in accordance with BDNF gene polymorphism and gender with following assessment of PASI scores compared with baseline after conventional treatment at week 10 in each group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Unpaired, two-way ANOVA and Bonferroni means separation tests for multiple comparisons of HAM-D scores in EAD, IAD, PS and HC</measure>
    <time_frame>At disease onset (study baseline) and week 10</time_frame>
    <description>Unpaired, two-way ANOVA and Bonferroni means separation tests will be used for multiple comparisons of HAM-D scores in EAD, IAD and PS patients and HC divided into subgroups in accordance with BDNF gene polymorphism and gender at disease onset (baseline) and week 10. Comparisons will include assessment of HAM-D scores in all patients at baseline and week 10 compared with HC, and assessment of data changes at week 10 compared with baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Unpaired, two-way ANOVA and Bonferroni means separation tests for multiple comparisons of HAM-A scores in EAD, IAD,PS and HC</measure>
    <time_frame>At disease onset (study baseline) and week 10</time_frame>
    <description>Unpaired, two-way ANOVA and Bonferroni means separation tests will be used for multiple comparisons of HAM-A scores in EAD, IAD and PS patients and HC divided into subgroups in accordance with BDNF gene polymorphism and gender at disease onset (baseline) and week 10. Comparisons will include assessment of HAM-A scores in all patients at baseline and week 10 compared with HC, and assessment of data changes at week 10 compared with baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Unpaired, two-way ANOVA and Bonferroni means separation tests for multiple comparisons of serum BDNF (ng/ml) levels in EAD, IAD,PS and HC</measure>
    <time_frame>At disease onset (study baseline) and at week 10</time_frame>
    <description>Unpaired, two-way ANOVA and Bonferroni means separation tests will be used for multiple comparisons of serum BDNF(ng/ml) levels in EAD, IAD and PS patients and HC divided into subgroups in accordance with BDNF gene polymorphism and gender at disease onset (baseline) and week 10. Comparisons will include assessment of serum BDNF levels in all patients at baseline and week 10 compared with HC, and assessment of data changes at week 10 compared with baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Unpaired, two-way ANOVA and Bonferroni means separation tests for multiple comparisons of serum cortisol (nmol/L) levels in EAD, IAD,PS and HC</measure>
    <time_frame>At disease onset (study baseline) and at week 10</time_frame>
    <description>Unpaired, two-way ANOVA and Bonferroni means separation tests will be used for comparisons of serum cortisol (nmol/L) levels in EAD, IAD and PS patients and HC divided into subgroups in accordance with BDNF gene polymorphism and gender at disease onset (baseline) and week 10. Comparisons will include assessment of serum cortisol levels in all patients at baseline and week 10 compared with HC, and assessment of data changes at week 10 compared with baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Unpaired, two-way ANOVA and Bonferroni means separation tests for multiple comparisons of serum testosterone (ng/dL) levels in EAD, IAD,PS and HC</measure>
    <time_frame>At disease onset (study baseline) and at week 10</time_frame>
    <description>Unpaired, two-way ANOVA and Bonferroni means separation tests will be used for multiple comparisons of serum testosterone (ng/dL) levels in EAD, IAD and PS patients and HC divided into subgroups in accordance with BDNF gene polymorphism and gender at disease onset (baseline) and week 10. Comparisons will include assessment of serum testosterone levels in all patients at baseline and week 10 compared with HC, and assessment of data changes at week 10 compared with baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of testosterone/cortisol ratio in EAD, IAD, PS patients and HC in accordance with BDNF rs6265 gene polymorphism and gender</measure>
    <time_frame>At disease onset (study baseline) and at week 10</time_frame>
    <description>Assessment of testosterone/cortisol ratio in EAD, IAD, PS patients and HC divided into BDNF rs6265 gene polymorphism (Val/Val; Val/Met; Met/Met) and gender (males, females) at study baseline and week 10</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Unpaired, two-way ANOVA and Bonferroni means separation tests for multiple comparisons of testosterone/cortisol ratio in EAD, IAD, PS and HC</measure>
    <time_frame>At disease onset (study baseline) and at week 10</time_frame>
    <description>Unpaired, two-way ANOVA and Bonferroni means separation tests will be used for multiple comparisons of testosterone/cortisol ratio in EAD, IAD and PS patients and HC divided into subgroups in accordance with BDNF gene polymorphism and gender at disease onset (baseline) and week 10. Comparisons will include assessment of testosterone/cortisol ratio in all patients at baseline and week 10 compared with HC, and assessment of data changes at week 10 compared with baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation analysis of studied parameters in dermatological patients and HC</measure>
    <time_frame>At disease onset (study baseline) and week 10</time_frame>
    <description>Correlation analysis of dermatological, psychological and biochemical parameters in EAD, IAD and PS patients, and HC divided into groups in accordance with BDNF rs6265 gene polymorphism (Val/Val; Val/Met; Met/Met) and gender (males, femaes)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">150</enrollment>
  <condition>Atopic Dermatitis</condition>
  <condition>Psoriasis</condition>
  <arm_group>
    <arm_group_label>dermatological patients</arm_group_label>
    <description>atopic dermatitis and psoriasis patients with mild and moderate severity of dermatoses in the stage of exacerbation</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      DNA are extracted using Wizard Genomic DNA purification (Promega, US, A1120) and measured&#xD;
      using NanoDrop 8000 (Thermo Scientific, US). Amplification of rs6265 allelic variants will be&#xD;
      performed in a Stratagene Mx 3000P (Agilent Technologies, US) with custom primers&#xD;
      (TCCTCATCCAACAGCTCTTCTATCA [C/T] GTGTTCGAAAGTGTCAGCCAATGAT; TaqMan SNP Genotyping Assay,&#xD;
      ThermoFisher Scientific, US).&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Atopic dermatitis and psorisis patiens older than 18 years with mild and moderate forms of&#xD;
        disease, and healthy volunteers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  mild and moderate atopic dermatitis and psoriasis&#xD;
&#xD;
          -  age of patients over 18 years&#xD;
&#xD;
          -  no systemic therapy (glucocorticosteroids, immunosuppressants and psychotropic drugs)&#xD;
             within the month prior the study and blood sampling&#xD;
&#xD;
          -  no history of mental or other dermatological disorders&#xD;
&#xD;
          -  no unstable non-dermatological medical conditions&#xD;
&#xD;
          -  good general physical health&#xD;
&#xD;
          -  no pregnancy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  unstable non-dermatological medical conditions&#xD;
&#xD;
          -  severe forms of AD and PS&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>AD and PS patients will be divided by gender for assessment of clinical, psychological and biochemical parameters and subsequent comparison with appropriate HC</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tatyana Vinnik, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Astana Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tatyana Vinnik</name>
      <address>
        <city>Astana</city>
        <zip>000010</zip>
        <country>Kazakhstan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Kazakhstan</country>
  </location_countries>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed/26520685</url>
    <description>Association of HPA axis hormones with copeptin after psychological stress differs by sex</description>
  </link>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed/23245205</url>
    <description>How does epidermal pathology interact with mental state?</description>
  </link>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed/21253405</url>
    <description>The roles of BDNF in the pathophysiology of major depression and in antidepressant treatment</description>
  </link>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed/22538247</url>
    <description>Increase in serum brain-derived neurotrophic factor in met allele carriers of the BDNF Val66Met polymorphism is specific to males</description>
  </link>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed/22844024</url>
    <description>Interaction between the BDNF gene Val/66/Met polymorphism and morning cortisol levels as a predictor of depression in adult women</description>
  </link>
  <link>
    <url>https://doi.org/10.1016/j.jaad.2018.08.063</url>
    <description>Association between atopic dermatitis, depression, and suicidal ideation: A systematic review and meta-analysis</description>
  </link>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed/27528460</url>
    <description>HPA axis in major depression: cortisol, clinical symptomatology and genetic variation predict cognition</description>
  </link>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed/27087278</url>
    <description>Childhood atopic dermatitis-Brain-derived neurotrophic factor correlates with serum eosinophil cationic protein and disease severity</description>
  </link>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed/29315742</url>
    <description>Depression- and anxiety-like behaviour is related to BDNF/TrkB signalling in a mouse model of psoriasis</description>
  </link>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed/25999864</url>
    <description>Serum testosterone levels and symptom-based depression subtypes in men</description>
  </link>
  <link>
    <url>http://dx.doi.org/10.1155/2013/138027</url>
    <description>Stress Evaluation in Adult Patients with Atopic Dermatitis Using Salivary Cortisol</description>
  </link>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>February 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>August 17, 2019</last_update_submitted>
  <last_update_submitted_qc>August 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Astana Medical University</investigator_affiliation>
    <investigator_full_name>Tatyana Vinnik</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>atopic dermatitis</keyword>
  <keyword>psoriasis</keyword>
  <keyword>brain-derived neurotrophic factor</keyword>
  <keyword>depression</keyword>
  <keyword>gender</keyword>
  <keyword>immunoglobulin E</keyword>
  <keyword>cortisol</keyword>
  <keyword>testosterone</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dermatitis, Atopic</mesh_term>
    <mesh_term>Psoriasis</mesh_term>
    <mesh_term>Dermatitis</mesh_term>
    <mesh_term>Eczema</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Confidentiality will be assured by means of a number coding system, and all completed research forms will be stored in secure areas</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03831646
org study id: 4
nct id: NCT03831646
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Atopic dermatitis (AD) and psoriasis (PS) are chronic, relapsing dermatological disorders
      with a high rate of psychiatric co-morbid pathology represented with depression. Brain
      Derived Neurotrophic Factor (BDNF) belongs to the neurotrophin family and widely studied in
      pathophysiology of psychiatric and dermatological disorders. A biological stress response
      system by altered hypothalamic-pituitary-adrenal (HPA) axis as well
      hypothalamic-pituitary-gonadal (HPG) axis may contribute to dermatoses and psychiatric
      disorders development. Various factors including gender, genetic, psychological stress,
      socioeconomic factors also affect the course of dermatoses.

      A 10-week, case-control study evaluate clinical, psychological and biochemical parameters in
      AD and PS patients, and healthy control volunteers (HC) depending on gender and BDNF rs6265
      gene polymorphism. All parameters are evaluated twice: at disease exacerbation (study
      baseline) and week 10.

      The following methods are conducted: assessment of dermatological status, using Scoring of
      Atopic Dermatitis (SCORAD) and Psoriasis Area and Severity Index (PASI); assessment of
      depression and anxiety according to DSM-V criteria and with Hamilton Depression Rating Scale
      (HAM-D) and with Hamilton Anxiety Rating Scale (HAM-A); analysis of serum BDNF (ng/ml),
      cortisol (nmol/L), testosterone (ng/dL) and IgE levels (IU/ml, AD only); DNA extraction and
      genotyping of BDNF variants.The study will last during 4-5 months.
Atopic dermatitis (AD) and psoriasis (PS) are related to psychodermatological disorders with
      chronic relapsing course, multifactorial etiology and complex pathogenesis. In accordance
      with DSM-V, AD and PS belong to psychosomatic disorders with psychogenic manifestation and
      exacerbation, whereas depression represents a high range of psychiatric co-morbid pathology
      in AD and PS patients. Brain Derived Neurotrophic Factor (BDNF) is a prominent representative
      of the neurotrophins family, widely studied in pathophysiology of psychiatric and
      dermatological disorders. Various factors including ethnicity, gender, genetic and
      socioeconomic causes as well methods of diagnosis and case definition may affect the course
      of dermatoses. A possible mechanism that contributes to dermatitis and psychiatric disorders
      development is dysregulation of the biological stress response system by altered
      hypothalamic-pituitary-adrenal (HPA) axis functioning. In addition many studies emphasize the
      role of gonadal hormones both in depression and dermatoses.

      This study evaluate clinical, psychological and biochemical parameters in AD and PS patients
      depending on gender and BDNF rs6265 gene polymorphism. Investigators conduct a 10-week,
      case-control study among AD and PS patients and healthy controls (HC) volunteers. All
      parameters are evaluated twice: at disease exacerbation (study baseline) and week 10.

      The following methods are used: assessment of dermatological status, using Scoring of Atopic
      Dermatitis (SCORAD) and Psoriasis Area and Severity Index (PASI); assessment of depression
      and anxiety according to DSM-V criteria and with Hamilton Depression Rating Scale (HAM-D) and
      Hamilton Anxiety Rating Scale (HAM-A); analysis of serum BDNF (ng/ml), cortisol (nmol/L),
      testosterone (ng/dL) and IgE levels (IU/ml, AD only); DNA extraction and genotyping of BDNF
      variants.

      Sample collection and processing: blood are taken between 8-10 a.m. to prevent daily
      variations on week 0 and week 10 and collected to serum-separation tubes (SST) and EDTA tubes
      (for DNA extraction); samples are cooled (1 hr, 4°C) and centrifuged (2000xg, 10 minutes,
      25°C); serum are stored at -20°C before analysis; DNA extraction from whole blood is
      performed≤3 days from collection and stored (-70°C).

      After written informed consent and first blood sample, patients are provided with
      conventional treatments. For AD this include antihistamines (e.g., diphenhydramine,
      desloratadine), topical corticosteroids (e.g., betamethasone, mometasone) up to 3 weeks and
      emollients up to 2 months; for PS we will prescribe antihistamines (e.g., diphenhydramine,
      desloratadine), topical corticosteroids (e.g., betamethasone, mometasone) up to 3 weeks and
      keratolytics (2% salicylic ointment) up to 2 weeks. Patients are not prescribed
      antidepressants and other psychotropic agents.

      For assessment of study parameters all patients and HC will be divided into subgroups
      according to gender (males, femaes) and BDNF gene polymorphism (Val/Val; Val/Met; Met/Met).
      Additionally AD patients will be divided by IgE sensitization: EAD (extrinsic, IgE sensitive)
      and IAD (intrinsic, IgE non-sensitive).

      The study will last for 4-5 months. Patients inclusion criteria: no pregnancy; no unstable
      non-dermatological medical conditions, no systemic therapy (glucocorticosteroids,
      immunosuppressants and psychotropic drugs) within the month prior the study and blood
      sampling, no history of mental or other dermatological disorders, no severe forms of AD and
      PS; good general physical health. Inclusion criteria for HC are no pregnancy and good general
      physical health.

      Statistics will be performed using unpaired t-test or paired t-test (week 0: week 10
      comparisons, verified by Pearson/Spearman correlation). Unpaired, one-way ANOVA and/or
      two-way ANOVA test will be used for multiple group comparisons. Data will be presented as
      mean±SEM.
observational model: Case-Control
time perspective: Prospective
measure: Assessment of change in the severity of atopic dermatitis after conventional treatment from study onset (baseline) at week 10
time frame: At disease onset (study baseline) and at week 10
description: Assessment of atopic dermatitis severity is conducted using Scoring of Atopic Dermatitis (SCORAD) index. SCORAD index formula is: A/5 + 7B/2 + C. In this formula A is defined as the extent (0-100), B is defined as the intensity (0-18) and C is defined as the subjective symptoms (0-20). The maximum SCORAD score is 103. SCORAD <23 - mild AD; SCORAD from 23 to 63 - moderate AD; SCORAD> 63 - severe AD.
measure: Assessment of change in the severity of psoriasis after conventional treatment from study onset (baseline) at week 10
time frame: At disease onset (study baseline) and at week 10
description: Assessment of the psoriasis severity is conducted using Psoriasis Area and Severity Index (PASI). The patient's body is divided into four sections (head (H) (10% of a person's skin); arms (A) (20%); trunk (T) (30%); legs (L) (40%)). The percent of skin lesions of each area is assessed as follows: 0 (0% of involved area); 1 (< 10%); 2 (10-29%); 3 (30-49%); 4 (50-69%); 5 (70-89%); 6 (90-100%). Further, for each region, the intensity of 3 clinical signs is evaluated - redness, thickness and scaling and assessed as follows: 0 - no lesions,1 - easy, 2 - moderate, 3 - severe, 4 - very severe. The sum of all three severity parameters is calculated for each section, multiplied by the area score for that area and multiplied by weight of respective section (0.1 for head, 0.2 for arms, 0.3 for body, 0.4 for legs). PASI range is from 0 (no disease) to 72 (maximum disease). The severity of psoriasis is assessed as follows: PASI <20 - mild; PASI from 20 to 50 - moderate; PASI> 50 - severe
measure: Assessment of change in the severity of depression in atopic dermatitis and psoriasis patients after conventional treatment from study onset (baseline) at week 10
time frame: At disease onset (study baseline) and week 10
description: Depression is assessed according to Diagnostic and Statistical Manual of Mental Disorders (DSM) -V criteria and with Hamilton Depression Rating Scale (HAM-D) using the following ranges: absence, ≤7; mild, 8-16; moderate, 17-27; severe, ≤28
measure: Assessment of the severity of depression in healthy controls (HC)
time frame: At disease onset (study baseline)
description: Depression is assessed according to Diagnostic and Statistical Manual of Mental Disorders (DSM) -V criteria and with Hamilton Depression Rating Scale (HAM-D) using the following ranges: absence, ≤7; mild, 8-16; moderate, 17-27; severe, ≤28
measure: Assessment of change in the severity of anxiety in atopic dermatitis and psoriasis patients after conventional treatment from study onset (baseline) at week 10
time frame: At disease onset (study baseline) and week 10
description: Anxiety is assessed according to Diagnostic and Statistical Manual of Mental Disorders (DSM) -V criteria and with Hamilton Anxiety Rating Scale (HAM-A) using the following ranges: ≤17, easy; 18-24, moderate; over 25, medium-severe
measure: Assessment of the severity of anxiety in HC
time frame: At disease onset (study baseline)
description: Anxiety is assessed according to Diagnostic and Statistical Manual of Mental Disorders (DSM) -V criteria and with Hamilton Anxiety Rating Scale (HAM-A) using the following ranges: ≤17, easy; 18-24, moderate; over 25, medium-severe
measure: Evaluation of changes in serum immunoglobulin E (IgE, IU/ml) levels from study onset (baseline) at week 10 in atopic dermatitis patients
time frame: At disease onset (study baseline) and week 10
description: The total IgE levels are detected using solid-phase, chemiluminescent immunometric assay in an Immulite/Immulite 1000 (Siemens, Germany). Normal ranges are as follow: 0.000-100.0 IU/ml
measure: Analysis of serum IgE (IU/ml) levels in HC
time frame: At disease onset (study baseline)
description: The total IgE levels are detected using solid-phase, chemiluminescent immunometric assay in an Immulite/Immulite 1000 (Siemens, Germany). Normal ranges are as follow: 0.000-100.0 IU/ml
measure: Evaluation of changes in serum Brain Derived Neurotrophic Factor (BDNF, ng/ml) levels from study onset (baseline) at week 10 in atopic dermatitis and psoriasis patients
time frame: At disease onset (study baseline) and week 10
description: Serum BDNF levels are analyzed using a solid-phase, sandwich, two-site, ELISA (Promega, US; G7610). No measurement scale is used
measure: Analysis of serum BDNF (ng/ml) levels in HC
time frame: At disease onset (study baseline)
description: Serum BDNF levels are analyzed using a solid-phase, sandwich, two-site, ELISA (Promega, US; G7610). No measurement scale is used
measure: Evaluation of changes in cortisol (nmol/L) levels from study onset (baseline) at week 10 in atopic dermatitis and psoriasis patients
time frame: At disease onset (study baseline) and week 10
description: The total cortisol levels are detected using solid-phase, chemiluminescent immunometric assay in an Immulite/Immulite 1000 (Siemens, Germany). Normal ranges are as follow: 138-690 nmol/L
measure: Analysis of serum cortisol (nmol/L) levels in HC
time frame: At disease onset (study baseline)
description: The total cortisol levels are detected using solid-phase, chemiluminescent immunometric assay in an Immulite/Immulite 1000 (Siemens, Germany). Normal ranges are as follow: 138-690 nmol/L
measure: Evaluation of changes in testosterone (ng/dL) levels from study onset (baseline) at week 10 in atopic dermatitis and psoriasis patients
time frame: At disease onset (study baseline) and week 10
description: The total testosterone levels are detected using solid-phase, chemiluminescent immunometric assay in an Immulite/Immulite 1000 (Siemens, Germany). Normal ranges are as follow: men 20-49 years - 72 -853ng/dL; men≥50 years -129-767 ng/dL; women ovulating - 0.010-73.0 ng/dL; women postmenopausal - 0.010-43.0 ng/dL.
measure: Analysis of serum testosterone (ng/dL) levels in HC
time frame: At disease onset (study baseline)
description: The total testosterone levels are detected using solid-phase, chemiluminescent immunometric assay in an Immulite/Immulite 1000 (Siemens, Germany). Normal ranges are as follow: men 20-49 years - 72 -853ng/dL; men≥50 years -129-767 ng/dL; women ovulating - 0.010-73.0 ng/dL; women postmenopausal - 0.010-43.0 ng/dL.
measure: DNA extraction in AD, PS and HC
time frame: At disease onset (study baseline)
description: DNA extraction and genotyping the BDNF rs6265 (Val66Met) gene polymorphism in AD, PS and HC
measure: Assessment and comparison (Unpaired t-test) of SCORAD scores in extrinsic atopic dermatitis (EAD, IgE level above the normal) and intrinsic atopic dermatitis (IAD, normal IgE level) patients compared with baseline after conventional treatment at week 10
time frame: At disease onset (study baseline) and week 10
description: EAD and IAD patients will be divided into subgroups in accordance with BDNF gene polymorphism and gender with following assessment of SCORAD scores compared with baseline after conventional treatment at week 10 in each group using unpaired t-test
measure: Assessment and comparison (Unpaired t-test) of PASI scores in psoriasis patients compared with baseline after conventional treatment at week 10 in accordance with BDNF gene polymorphism (Val/Val; Val/Met;Met/Met) and gender(males, females)
time frame: At disease onset (study baseline) and week 10
description: Psoriasis patients will be divided into subgroups in accordance with BDNF gene polymorphism and gender with following assessment of PASI scores compared with baseline after conventional treatment at week 10 in each group.
measure: Unpaired, two-way ANOVA and Bonferroni means separation tests for multiple comparisons of HAM-D scores in EAD, IAD, PS and HC
time frame: At disease onset (study baseline) and week 10
description: Unpaired, two-way ANOVA and Bonferroni means separation tests will be used for multiple comparisons of HAM-D scores in EAD, IAD and PS patients and HC divided into subgroups in accordance with BDNF gene polymorphism and gender at disease onset (baseline) and week 10. Comparisons will include assessment of HAM-D scores in all patients at baseline and week 10 compared with HC, and assessment of data changes at week 10 compared with baseline
measure: Unpaired, two-way ANOVA and Bonferroni means separation tests for multiple comparisons of HAM-A scores in EAD, IAD,PS and HC
time frame: At disease onset (study baseline) and week 10
description: Unpaired, two-way ANOVA and Bonferroni means separation tests will be used for multiple comparisons of HAM-A scores in EAD, IAD and PS patients and HC divided into subgroups in accordance with BDNF gene polymorphism and gender at disease onset (baseline) and week 10. Comparisons will include assessment of HAM-A scores in all patients at baseline and week 10 compared with HC, and assessment of data changes at week 10 compared with baseline
measure: Unpaired, two-way ANOVA and Bonferroni means separation tests for multiple comparisons of serum BDNF (ng/ml) levels in EAD, IAD,PS and HC
time frame: At disease onset (study baseline) and at week 10
description: Unpaired, two-way ANOVA and Bonferroni means separation tests will be used for multiple comparisons of serum BDNF(ng/ml) levels in EAD, IAD and PS patients and HC divided into subgroups in accordance with BDNF gene polymorphism and gender at disease onset (baseline) and week 10. Comparisons will include assessment of serum BDNF levels in all patients at baseline and week 10 compared with HC, and assessment of data changes at week 10 compared with baseline
measure: Unpaired, two-way ANOVA and Bonferroni means separation tests for multiple comparisons of serum cortisol (nmol/L) levels in EAD, IAD,PS and HC
time frame: At disease onset (study baseline) and at week 10
description: Unpaired, two-way ANOVA and Bonferroni means separation tests will be used for comparisons of serum cortisol (nmol/L) levels in EAD, IAD and PS patients and HC divided into subgroups in accordance with BDNF gene polymorphism and gender at disease onset (baseline) and week 10. Comparisons will include assessment of serum cortisol levels in all patients at baseline and week 10 compared with HC, and assessment of data changes at week 10 compared with baseline
measure: Unpaired, two-way ANOVA and Bonferroni means separation tests for multiple comparisons of serum testosterone (ng/dL) levels in EAD, IAD,PS and HC
time frame: At disease onset (study baseline) and at week 10
description: Unpaired, two-way ANOVA and Bonferroni means separation tests will be used for multiple comparisons of serum testosterone (ng/dL) levels in EAD, IAD and PS patients and HC divided into subgroups in accordance with BDNF gene polymorphism and gender at disease onset (baseline) and week 10. Comparisons will include assessment of serum testosterone levels in all patients at baseline and week 10 compared with HC, and assessment of data changes at week 10 compared with baseline
measure: Assessment of testosterone/cortisol ratio in EAD, IAD, PS patients and HC in accordance with BDNF rs6265 gene polymorphism and gender
time frame: At disease onset (study baseline) and at week 10
description: Assessment of testosterone/cortisol ratio in EAD, IAD, PS patients and HC divided into BDNF rs6265 gene polymorphism (Val/Val; Val/Met; Met/Met) and gender (males, females) at study baseline and week 10
measure: Unpaired, two-way ANOVA and Bonferroni means separation tests for multiple comparisons of testosterone/cortisol ratio in EAD, IAD, PS and HC
time frame: At disease onset (study baseline) and at week 10
description: Unpaired, two-way ANOVA and Bonferroni means separation tests will be used for multiple comparisons of testosterone/cortisol ratio in EAD, IAD and PS patients and HC divided into subgroups in accordance with BDNF gene polymorphism and gender at disease onset (baseline) and week 10. Comparisons will include assessment of testosterone/cortisol ratio in all patients at baseline and week 10 compared with HC, and assessment of data changes at week 10 compared with baseline
measure: Correlation analysis of studied parameters in dermatological patients and HC
time frame: At disease onset (study baseline) and week 10
description: Correlation analysis of dermatological, psychological and biochemical parameters in EAD, IAD and PS patients, and HC divided into groups in accordance with BDNF rs6265 gene polymorphism (Val/Val; Val/Met; Met/Met) and gender (males, femaes)
arm group label: dermatological patients
description: atopic dermatitis and psoriasis patients with mild and moderate severity of dermatoses in the stage of exacerbation
DNA are extracted using Wizard Genomic DNA purification (Promega, US, A1120) and measured
      using NanoDrop 8000 (Thermo Scientific, US). Amplification of rs6265 allelic variants will be
      performed in a Stratagene Mx 3000P (Agilent Technologies, US) with custom primers
      (TCCTCATCCAACAGCTCTTCTATCA [C/T] GTGTTCGAAAGTGTCAGCCAATGAT; TaqMan SNP Genotyping Assay,
      ThermoFisher Scientific, US).
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
gender based: Yes
gender description: AD and PS patients will be divided by gender for assessment of clinical, psychological and biochemical parameters and subsequent comparison with appropriate HC
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Tatyana Vinnik, MD, PhD
role: Principal Investigator
affiliation: Astana Medical University
facility: 
country: Kazakhstan
url: http://www.ncbi.nlm.nih.gov/pubmed/26520685
description: Association of HPA axis hormones with copeptin after psychological stress differs by sex
url: http://www.ncbi.nlm.nih.gov/pubmed/23245205
description: How does epidermal pathology interact with mental state?
url: http://www.ncbi.nlm.nih.gov/pubmed/21253405
description: The roles of BDNF in the pathophysiology of major depression and in antidepressant treatment
url: http://www.ncbi.nlm.nih.gov/pubmed/22538247
description: Increase in serum brain-derived neurotrophic factor in met allele carriers of the BDNF Val66Met polymorphism is specific to males
url: http://www.ncbi.nlm.nih.gov/pubmed/22844024
description: Interaction between the BDNF gene Val/66/Met polymorphism and morning cortisol levels as a predictor of depression in adult women
url: https://doi.org/10.1016/j.jaad.2018.08.063
description: Association between atopic dermatitis, depression, and suicidal ideation: A systematic review and meta-analysis
url: http://www.ncbi.nlm.nih.gov/pubmed/27528460
description: HPA axis in major depression: cortisol, clinical symptomatology and genetic variation predict cognition
url: http://www.ncbi.nlm.nih.gov/pubmed/27087278
description: Childhood atopic dermatitis-Brain-derived neurotrophic factor correlates with serum eosinophil cationic protein and disease severity
url: http://www.ncbi.nlm.nih.gov/pubmed/29315742
description: Depression- and anxiety-like behaviour is related to BDNF/TrkB signalling in a mouse model of psoriasis
url: http://www.ncbi.nlm.nih.gov/pubmed/25999864
description: Serum testosterone levels and symptom-based depression subtypes in men
url: http://dx.doi.org/10.1155/2013/138027
description: Stress Evaluation in Adult Patients with Atopic Dermatitis Using Salivary Cortisol
responsible party type: Principal Investigator
investigator affiliation: Astana Medical University
investigator full name: Tatyana Vinnik
investigator title: Assistant Professor
mesh term: Dermatitis, Atopic
mesh term: Psoriasis
mesh term: Dermatitis
mesh term: Eczema
sharing ipd: No
ipd description: Confidentiality will be assured by means of a number coding system, and all completed research forms will be stored in secure areas