<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/NCT04482296</url>
  </required_header>
  <id_info>
    <org_study_id>BSMMU/2019/8875</org_study_id>
    <nct_id>NCT04482296</nct_id>
  </id_info>
  <brief_title>Effect of Zinc Supplementation on Depression in SSRI-treated Major Depressive Disorder Patients</brief_title>
  <official_title>Effect of Zinc Supplementation on Depression in Selective Serotonin Reuptake Inhibitors-treated Major Depressive Disorder Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh</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>
      Title:&#xD;
&#xD;
      Effect of zinc supplementation on depression in SSRIs-treated MDD patients.&#xD;
&#xD;
      Purpose: Depression is the single largest contributor to global disability as has been ranked&#xD;
      by WHO (2015), in humans including both male and female.Studies have suggested that&#xD;
      conventional presently available anti-depressive medicines are effective for one third to&#xD;
      one-half (19-34%) of the patients suffering from depression, leaving the rest of patients to&#xD;
      suffer from recurrence or incomplete cure. Researchers throughout the world are involved to&#xD;
      obtain new pharmacotherapy for the treatment of MDD. Zinc is an important micronutrient of&#xD;
      the human body which is implicated as an essential component in various systemic wellbeing&#xD;
      including the central nervous system.&#xD;
&#xD;
      Methods: The study would be randomized, double-blind, placebo-controlled prospective&#xD;
      interventional trial and it would be conducted in the Department of Pharmacology and in&#xD;
      collaboration with the Department of Psychiatry, BSMMU, from date of approval by the IRB to&#xD;
      August 2020. A total of 100 patients suffering from mild to moderate major depression will be&#xD;
      selected following to inclusion and exclusion criteria and serum Zinc levels will be&#xD;
      assessed. The diagnosis of patients suffering from MDD and the selection of drugs and dosage&#xD;
      would be performed by a senior professor of the Psychiatry department. After completing the&#xD;
      necessary formalities including the informed consent of the patients, the patient would&#xD;
      undergo a selected questionnaire (DASS-21) to assess his/her degree of severity of the&#xD;
      disease. The patients would be randomly allocated into two groups: group A (control group)&#xD;
      and B (intervention group). Group A would consist of 50 patients who will receive a placebo&#xD;
      with SSRIs for 8 weeks. Group B would consist of 50 patients who will receive SSRIs plus Zinc&#xD;
      sulfate (30mg/day) orally for 8 weeks, after which at follow up, the severity of depression&#xD;
      will be assessed. The blood sample will be collected to measure serum zinc level at baseline&#xD;
      and again after 8 weeks of therapeutic intervention.&#xD;
&#xD;
      Ethical consideration&#xD;
&#xD;
      The study will follow the principles of the Declaration of Helsinki and of the World Medical&#xD;
      Assembly. Patients will be informed about the study in easy language and then informed&#xD;
      consent will be taken. The study has no potential risk to the patients. Confidentiality will&#xD;
      be strictly maintained.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Depression (MDD) is a major global health problem. The number of people suffering from major&#xD;
      depressive disorder was reported as around 300 million (about 4.4% of the world's population)&#xD;
      in 2015. The total number is assumed to increase to 18.4% from 2005 to 2015. Depression is&#xD;
      more common in females compared to males (female: male = 5.1:3.6). Years lived with a&#xD;
      disability are about 50 million people due to major depressive disorder and this disease has&#xD;
      been claimed to be a major cause of morbidity, mortality, and also suicidal death. In&#xD;
      Bangladesh, the prevalence of depressive disorder is about 4.1% and the percentage of total&#xD;
      years lived with a disability (DALY) is about 7.1%. Within this number, some people suffer&#xD;
      additionally from anxiety disorders and some suffer from both anxiety disorder and MDD.&#xD;
      However, MDD has been assumed to occupy the place of the second cause of disability by 2020,&#xD;
      and MDD, therefore, demands attention and alerts in clinical psychiatry. Depression impairs&#xD;
      quality of life at the level of personal, familial, and social aspects and in the severe&#xD;
      form, may lead to thoughts of committing suicide. Suicidal death (about 8,00000 per year)&#xD;
      have been reported throughout the world in recent reports and are increasing gradually.&#xD;
      Conventional antidepressants are the medicines used to treat MDD. Increasing 5HT&#xD;
      concentrations at the synapses of the amygdala, frontal cortex, or the limbic region by SSRI&#xD;
      or TCA or other drugs administration remains the primary object of therapy. About 19-34% of&#xD;
      MDD patients show a reasonable level of response to the SSRIs while about 15-50% of patients&#xD;
      show dissatisfactory response or recurrence. This fact is a subject of concern and invite&#xD;
      pharmacological intervention either in the form of adjunct drugs or new drug discoveries.&#xD;
      Recent researches have revealed that a significant role of zinc in MDD patients due to its&#xD;
      antidepressant effects. Some studies reported that there is no effect of zinc supplementation&#xD;
      on depression in MDD patients. Because of the conflicted reports, this study has been&#xD;
      designed to evaluate the effect of zinc supplementation on depression in MDD patients treated&#xD;
      with SSRI. Results of this study may be helpful to advocate the regular use of zinc&#xD;
      supplementation as an adjunct to SSRI therapy in MDD. The study would be randomized,&#xD;
      double-blind, placebo-controlled prospective interventional trial and it would be conducted&#xD;
      in the Department of Pharmacology and in collaboration with the Department of Psychiatry,&#xD;
      BSMMU, from the date of approval by the IRB to August 2020. A total of 100 patients suffering&#xD;
      from mild to moderate major depression will be selected following to inclusion and exclusion&#xD;
      criteria and serum Zinc levels will be assessed. The diagnosis of patients suffering from MDD&#xD;
      and the selection of drugs and dosage would be performed by a senior professor of the&#xD;
      Psychiatry department. After completing the necessary formalities including the informed&#xD;
      consent of the patients, the patient would undergo a selected questionnaire (DASS-21) to&#xD;
      assess his/her degree of severity of the disease. The patients would be randomly allocated&#xD;
      into two groups: group A (control group) and B (intervention group). Group A would consist of&#xD;
      50 patients who will receive a placebo with SSRIs for 8 weeks. Group B would consist of 50&#xD;
      patients who will receive SSRIs plus Zinc sulfate (30mg/day) orally for 8 weeks, after which&#xD;
      at follow up, the severity of depression will be assessed. The blood sample will be collected&#xD;
      to measure serum zinc level at baseline and again after 8 weeks of therapeutic intervention.&#xD;
      The regularity of medicine intake will be ensured over the telephone, counting the tablets,&#xD;
      and from the patient's compliance sheet. The study entails almost no potential risk to the&#xD;
      patients which will be explained to the patients together with the fact that he/she would be&#xD;
      free to leave the study at any time and that he/she would receive free of cost treatment in&#xD;
      case of any adverse reactions. Statistical analysis will be obtained by SPSS (Statistical&#xD;
      Package for Social Science). Results will be presented in tables and graphical figures as&#xD;
      applicable. Calculated 'p' value may suggest the level of significance (significant at p ≤&#xD;
      0.050). The study will follow the principles of the Declaration of Helsinki and of the World&#xD;
      Medical Assembly. Patients will be informed about the study in easy language and then&#xD;
      informed consent will be taken. The study has no potential risk to the patients.&#xD;
      Confidentiality will be strictly maintained.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 15, 2019</start_date>
  <completion_date type="Actual">August 20, 2020</completion_date>
  <primary_completion_date type="Actual">July 15, 2020</primary_completion_date>
  <phase>N/A</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To measure the serum zinc level in SSRI-treated MDD patients pre and post supplementation of zinc.</measure>
    <time_frame>8 weeks</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>MDD</condition>
  <arm_group>
    <arm_group_label>SSRI with placebo</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>50 patients who will receive placebo with SSRIs for 8 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SSRI with zinc sulfate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>50 patients who will receive SSRIs with zinc sulfate for 8 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SSRI with Zinc Sulfate</intervention_name>
    <description>Zinc sulfate (30 mg) once daily for 8 weeks SSRI</description>
    <arm_group_label>SSRI with zinc sulfate</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Newly diagnosed patients with major depressive disorder diagnosed from the Psychiatry&#xD;
             department of BSMMU according to the diagnostic protocol which fulfills DSM-4 criteria&#xD;
             and SCID 1 Bangla version.&#xD;
&#xD;
          -  Patients treated with only SSRIs.&#xD;
&#xD;
          -  Mild to moderate MDD patients.&#xD;
&#xD;
          -  Age: 18-55 years.&#xD;
&#xD;
          -  Sex: Both male and female.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Age &lt; 18 years and &gt; 55 years.&#xD;
&#xD;
          -  Patients receiving other antidepressants and dietary supplements in the last two&#xD;
             months.&#xD;
&#xD;
          -  Patients with other psychiatric disorders (such as anxiety disorder, schizophrenia,&#xD;
             bipolar disorder, alcoholism).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Satabdi Ghosh, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>BSMMU(Recruiting), Dhaka, Bangladesh, 1000</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>BSMMU</name>
      <address>
        <city>Dhaka</city>
        <country>Bangladesh</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bangladesh</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>January 26, 2021</last_update_submitted>
  <last_update_submitted_qc>January 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh</investigator_affiliation>
    <investigator_full_name>Dr. Satabdi Ghosh</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>Zinc</keyword>
  <keyword>SSRI</keyword>
  <keyword>MDD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Depressive Disorder, Major</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Zinc Sulfate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04482296
org study id: BSMMU/2019/8875
nct id: NCT04482296
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Title:

      Effect of zinc supplementation on depression in SSRIs-treated MDD patients.

      Purpose: Depression is the single largest contributor to global disability as has been ranked
      by WHO (2015), in humans including both male and female.Studies have suggested that
      conventional presently available anti-depressive medicines are effective for one third to
      one-half (19-34%) of the patients suffering from depression, leaving the rest of patients to
      suffer from recurrence or incomplete cure. Researchers throughout the world are involved to
      obtain new pharmacotherapy for the treatment of MDD. Zinc is an important micronutrient of
      the human body which is implicated as an essential component in various systemic wellbeing
      including the central nervous system.

      Methods: The study would be randomized, double-blind, placebo-controlled prospective
      interventional trial and it would be conducted in the Department of Pharmacology and in
      collaboration with the Department of Psychiatry, BSMMU, from date of approval by the IRB to
      August 2020. A total of 100 patients suffering from mild to moderate major depression will be
      selected following to inclusion and exclusion criteria and serum Zinc levels will be
      assessed. The diagnosis of patients suffering from MDD and the selection of drugs and dosage
      would be performed by a senior professor of the Psychiatry department. After completing the
      necessary formalities including the informed consent of the patients, the patient would
      undergo a selected questionnaire (DASS-21) to assess his/her degree of severity of the
      disease. The patients would be randomly allocated into two groups: group A (control group)
      and B (intervention group). Group A would consist of 50 patients who will receive a placebo
      with SSRIs for 8 weeks. Group B would consist of 50 patients who will receive SSRIs plus Zinc
      sulfate (30mg/day) orally for 8 weeks, after which at follow up, the severity of depression
      will be assessed. The blood sample will be collected to measure serum zinc level at baseline
      and again after 8 weeks of therapeutic intervention.

      Ethical consideration

      The study will follow the principles of the Declaration of Helsinki and of the World Medical
      Assembly. Patients will be informed about the study in easy language and then informed
      consent will be taken. The study has no potential risk to the patients. Confidentiality will
      be strictly maintained.
Depression (MDD) is a major global health problem. The number of people suffering from major
      depressive disorder was reported as around 300 million (about 4.4% of the world's population)
      in 2015. The total number is assumed to increase to 18.4% from 2005 to 2015. Depression is
      more common in females compared to males (female: male = 5.1:3.6). Years lived with a
      disability are about 50 million people due to major depressive disorder and this disease has
      been claimed to be a major cause of morbidity, mortality, and also suicidal death. In
      Bangladesh, the prevalence of depressive disorder is about 4.1% and the percentage of total
      years lived with a disability (DALY) is about 7.1%. Within this number, some people suffer
      additionally from anxiety disorders and some suffer from both anxiety disorder and MDD.
      However, MDD has been assumed to occupy the place of the second cause of disability by 2020,
      and MDD, therefore, demands attention and alerts in clinical psychiatry. Depression impairs
      quality of life at the level of personal, familial, and social aspects and in the severe
      form, may lead to thoughts of committing suicide. Suicidal death (about 8,00000 per year)
      have been reported throughout the world in recent reports and are increasing gradually.
      Conventional antidepressants are the medicines used to treat MDD. Increasing 5HT
      concentrations at the synapses of the amygdala, frontal cortex, or the limbic region by SSRI
      or TCA or other drugs administration remains the primary object of therapy. About 19-34% of
      MDD patients show a reasonable level of response to the SSRIs while about 15-50% of patients
      show dissatisfactory response or recurrence. This fact is a subject of concern and invite
      pharmacological intervention either in the form of adjunct drugs or new drug discoveries.
      Recent researches have revealed that a significant role of zinc in MDD patients due to its
      antidepressant effects. Some studies reported that there is no effect of zinc supplementation
      on depression in MDD patients. Because of the conflicted reports, this study has been
      designed to evaluate the effect of zinc supplementation on depression in MDD patients treated
      with SSRI. Results of this study may be helpful to advocate the regular use of zinc
      supplementation as an adjunct to SSRI therapy in MDD. The study would be randomized,
      double-blind, placebo-controlled prospective interventional trial and it would be conducted
      in the Department of Pharmacology and in collaboration with the Department of Psychiatry,
      BSMMU, from the date of approval by the IRB to August 2020. A total of 100 patients suffering
      from mild to moderate major depression will be selected following to inclusion and exclusion
      criteria and serum Zinc levels will be assessed. The diagnosis of patients suffering from MDD
      and the selection of drugs and dosage would be performed by a senior professor of the
      Psychiatry department. After completing the necessary formalities including the informed
      consent of the patients, the patient would undergo a selected questionnaire (DASS-21) to
      assess his/her degree of severity of the disease. The patients would be randomly allocated
      into two groups: group A (control group) and B (intervention group). Group A would consist of
      50 patients who will receive a placebo with SSRIs for 8 weeks. Group B would consist of 50
      patients who will receive SSRIs plus Zinc sulfate (30mg/day) orally for 8 weeks, after which
      at follow up, the severity of depression will be assessed. The blood sample will be collected
      to measure serum zinc level at baseline and again after 8 weeks of therapeutic intervention.
      The regularity of medicine intake will be ensured over the telephone, counting the tablets,
      and from the patient's compliance sheet. The study entails almost no potential risk to the
      patients which will be explained to the patients together with the fact that he/she would be
      free to leave the study at any time and that he/she would receive free of cost treatment in
      case of any adverse reactions. Statistical analysis will be obtained by SPSS (Statistical
      Package for Social Science). Results will be presented in tables and graphical figures as
      applicable. Calculated 'p' value may suggest the level of significance (significant at p ≤
      0.050). The study will follow the principles of the Declaration of Helsinki and of the World
      Medical Assembly. Patients will be informed about the study in easy language and then
      informed consent will be taken. The study has no potential risk to the patients.
      Confidentiality will be strictly maintained.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: To measure the serum zinc level in SSRI-treated MDD patients pre and post supplementation of zinc.
time frame: 8 weeks
arm group label: SSRI with placebo
arm group type: No Intervention
description: 50 patients who will receive placebo with SSRIs for 8 weeks
arm group label: SSRI with zinc sulfate
arm group type: Active Comparator
description: 50 patients who will receive SSRIs with zinc sulfate for 8 weeks
intervention type: Drug
intervention name: SSRI with Zinc Sulfate
description: Zinc sulfate (30 mg) once daily for 8 weeks SSRI
arm group label: SSRI with zinc sulfate
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Satabdi Ghosh, MBBS
role: Principal Investigator
affiliation: BSMMU(Recruiting), Dhaka, Bangladesh, 1000
facility: 
country: Bangladesh
responsible party type: Principal Investigator
investigator affiliation: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
investigator full name: Dr. Satabdi Ghosh
investigator title: Principal investigator
mesh term: Depressive Disorder
mesh term: Depressive Disorder, Major
mesh term: Zinc Sulfate
sharing ipd: No