<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/NCT03754647</url>
  </required_header>
  <id_info>
    <org_study_id>BSMMU/2018/3110</org_study_id>
    <nct_id>NCT03754647</nct_id>
  </id_info>
  <brief_title>Effect of Vitamin C Upon SSRI-treated OCD Patients</brief_title>
  <official_title>Effect of Vitamin C Upon Selective Serotonin Reuptake Inhibitors-treated Obsessive Compulsive 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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Title:&#xD;
&#xD;
      Effect of Vitamin C upon Selective Serotonin Reuptake Inhibitors (SSRIs) - treated Obsessive&#xD;
      Compulsive Disorder (OCD) patients.&#xD;
&#xD;
      Purpose of the study:&#xD;
&#xD;
      This study aims to examine the effect of vitamin C upon Selective Serotonin Reuptake&#xD;
      Inhibitors (SSRIs) - treated Obsessive Compulsive Disorder patients.&#xD;
&#xD;
      Method:&#xD;
&#xD;
      It will be a prospective type of interventional study to to assess the effects of vitamin C&#xD;
      along with SSRIs upon OCD patients. The study will be conducted in the Department of&#xD;
      Pharmacology and Department of Psychiatry, BSMMU, from September 2017 to February 2019. A&#xD;
      total of 90 OCD patients will be selected according to inclusion and exclusion criteria. The&#xD;
      patients will be divided randomly into 2 groups: group A and group B. Group A will consist of&#xD;
      45 patients who will receive only SSRIs orally daily and group B would consist of 45 patients&#xD;
      who will receive vitamin C, 500 mg BID orally daily along with SSRIs for 8 weeks. To see the&#xD;
      effects of Vitamin C, Yale-Brown score of obsessive-compulsive disorders (Y-OCD) would be&#xD;
      assessed by Yale-Brown Obsessive Compulsive Scale (Y-BOCS) at baseline (before vitamin C&#xD;
      administration) and 8 weeks after intervention. Biochemical parameters of oxidative stress&#xD;
      markers such as plasma malondialdehyde (MDA), plasma reduced glutathione (GSH) and plasma&#xD;
      vitamin C level would also be performed at baseline (before vitamin C administration) and 8&#xD;
      weeks after 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. This study has no potential risk to the patients. Confidentiality will&#xD;
      be strictly maintained.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Obsessive compulsive disorder (OCD) is the fourth-most common mental disorder. The World&#xD;
      Health Organization (WHO) estimated OCD to be among the top 10 causes of years lived with&#xD;
      illness related disability by 2020. Various psychological, social, genetic and biochemical&#xD;
      factors are presumed to be involved in the etiology of OCD. Researches so far have indicated&#xD;
      that free radical induced injuries are involved in the pathology of OCD. A well-known source&#xD;
      of antioxidant is Vitamin C, which is easily available, cheap and more powerful regarding&#xD;
      antioxidant effects compared to many other natural sources of vitamin C. Until now little&#xD;
      study has been performed to observe the effect of vitamin C administration concurrent to the&#xD;
      Selective Serotonin Reuptake Inhibitors (SSRIs) in the treatment of OCD. Therefore the&#xD;
      present study has been designed to assess the effects of vitamin C along with SSRIs upon OCD&#xD;
      patients. The study would be a prospective type of interventional study to be conducted in&#xD;
      the Department of Pharmacology and Department of Psychiatry, BSMMU, from September 2017 to&#xD;
      February 2019. A total of 90 OCD patients will be selected according to inclusion and&#xD;
      exclusion criteria. The patients will be divided randomly into 2 groups: group A and group B.&#xD;
      Group A would consist of 45 patients who will receive only SSRIs orally daily and group B&#xD;
      would consist of 45 patients who will receive vitamin C, 500 mg BID orally daily along with&#xD;
      SSRIs for 8 weeks. Comparison between the two groups will be performed through biochemical&#xD;
      parameters of oxidative stress markers such as serum malondialdehyde (MDA), serum reduced&#xD;
      glutathione (GSH) and serum vitamin C levels at baseline (before vitamin C administration)&#xD;
      and 8 weeks after intervention by vitamin C. Along with the biochemical parameters,&#xD;
      Yale-Brown score of obsessive-compulsive disorders (Y-OCD) would also be assessed by&#xD;
      Yale-Brown Obsessive Compulsive Scale (Y-BOCS).Data would be analyzed by Scientific Package&#xD;
      for Social Science(SPSS) and represented by tables and figures as applicable. Significance&#xD;
      level would be set at 0.05, 0.01 and 0.001. Patient's data will be recorded in a&#xD;
      predetermined data sheet. Patients will be informed about the study in easy language and then&#xD;
      informed consent will be taken. This study has no potential risk to the patients. Hence, this&#xD;
      study would be the first to examine the efficacy of vitamin C as an adjunct to SSRIs in the&#xD;
      treatment of OCD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 14, 2017</start_date>
  <completion_date type="Anticipated">February 10, 2019</completion_date>
  <primary_completion_date type="Anticipated">February 10, 2019</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To examine the effect of vitamin C upon Selective Serotonin Reuptake Inhibitors (SSRIs) - treated Obsessive Compulsive Disorder patients.</measure>
    <time_frame>8 weeks</time_frame>
    <description>To assess the clinical improvement of OCD patients by Yale-Brown Obsessive Compulsive Scale (Y-BOCS) and compare plasma MDA, RBC glutathione, plasma vitamin C levels at baseline and after 8 weeks of treatment.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>OCD</condition>
  <arm_group>
    <arm_group_label>Patients receiving SSRIs</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This group will be receive SSRIs only</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients receiving Vitamin C with SSRIs</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will be receive vitamin C (500mg) twice daily with SSRIs for 8 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Vitamin C</intervention_name>
    <description>One tablet of Vitamin C (500 mg) twice daily with SSRIs for 8 weeks</description>
    <arm_group_label>Patients receiving Vitamin C with SSRIs</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with OCD diagnosed by Psychiatry Department of BSMMU.&#xD;
&#xD;
          -  OCD patients fulfills Diagnostic criteria of DSM-5.&#xD;
&#xD;
          -  Insufficient or depleted plasma Vitamin C level 0.2-0.39 mg/dl or 11-28 µmol/L.&#xD;
&#xD;
          -  Patients with YBOCS score more than 14.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any physical or systemic illness / handicaps.&#xD;
&#xD;
          -  Alcohol or substance abuse or dependence.&#xD;
&#xD;
          -  Patients with Diabetes, Malignancy, Renal or Hepatic diseases.&#xD;
&#xD;
          -  Patients receiving antidepressants within last 2 months.&#xD;
&#xD;
          -  Patients with other psychological disorder (such as schizophrenia, bipolar disorder).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Taslima Akter, MBBS</last_name>
    <phone>01738248318</phone>
    <email>taslimamostafij@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>RAM Mostafizur Rashid, MBBS</last_name>
    <phone>01724840401</phone>
    <email>mostafizrmc@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>BSMMU</name>
      <address>
        <city>Dhaka</city>
        <zip>1000</zip>
        <country>Bangladesh</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Taslima Akter, MBBS</last_name>
      <phone>01738248318</phone>
      <email>Taslimamostafij@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>RAM Mostafizur Rashid, MBBS</last_name>
      <phone>01724840401</phone>
      <email>mostafizrmc@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Bangladesh</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 25, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>November 27, 2018</last_update_submitted>
  <last_update_submitted_qc>November 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 28, 2018</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.Taslima Akter</investigator_full_name>
    <investigator_title>MD, Resident</investigator_title>
  </responsible_party>
  <keyword>Vitamin C</keyword>
  <keyword>OCD</keyword>
  <keyword>MDA</keyword>
  <keyword>RBC Glutathione</keyword>
  <!-- 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/NCT03754647
org study id: BSMMU/2018/3110
nct id: NCT03754647
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Title:

      Effect of Vitamin C upon Selective Serotonin Reuptake Inhibitors (SSRIs) - treated Obsessive
      Compulsive Disorder (OCD) patients.

      Purpose of the study:

      This study aims to examine the effect of vitamin C upon Selective Serotonin Reuptake
      Inhibitors (SSRIs) - treated Obsessive Compulsive Disorder patients.

      Method:

      It will be a prospective type of interventional study to to assess the effects of vitamin C
      along with SSRIs upon OCD patients. The study will be conducted in the Department of
      Pharmacology and Department of Psychiatry, BSMMU, from September 2017 to February 2019. A
      total of 90 OCD patients will be selected according to inclusion and exclusion criteria. The
      patients will be divided randomly into 2 groups: group A and group B. Group A will consist of
      45 patients who will receive only SSRIs orally daily and group B would consist of 45 patients
      who will receive vitamin C, 500 mg BID orally daily along with SSRIs for 8 weeks. To see the
      effects of Vitamin C, Yale-Brown score of obsessive-compulsive disorders (Y-OCD) would be
      assessed by Yale-Brown Obsessive Compulsive Scale (Y-BOCS) at baseline (before vitamin C
      administration) and 8 weeks after intervention. Biochemical parameters of oxidative stress
      markers such as plasma malondialdehyde (MDA), plasma reduced glutathione (GSH) and plasma
      vitamin C level would also be performed at baseline (before vitamin C administration) and 8
      weeks after 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. This study has no potential risk to the patients. Confidentiality will
      be strictly maintained.
Obsessive compulsive disorder (OCD) is the fourth-most common mental disorder. The World
      Health Organization (WHO) estimated OCD to be among the top 10 causes of years lived with
      illness related disability by 2020. Various psychological, social, genetic and biochemical
      factors are presumed to be involved in the etiology of OCD. Researches so far have indicated
      that free radical induced injuries are involved in the pathology of OCD. A well-known source
      of antioxidant is Vitamin C, which is easily available, cheap and more powerful regarding
      antioxidant effects compared to many other natural sources of vitamin C. Until now little
      study has been performed to observe the effect of vitamin C administration concurrent to the
      Selective Serotonin Reuptake Inhibitors (SSRIs) in the treatment of OCD. Therefore the
      present study has been designed to assess the effects of vitamin C along with SSRIs upon OCD
      patients. The study would be a prospective type of interventional study to be conducted in
      the Department of Pharmacology and Department of Psychiatry, BSMMU, from September 2017 to
      February 2019. A total of 90 OCD patients will be selected according to inclusion and
      exclusion criteria. The patients will be divided randomly into 2 groups: group A and group B.
      Group A would consist of 45 patients who will receive only SSRIs orally daily and group B
      would consist of 45 patients who will receive vitamin C, 500 mg BID orally daily along with
      SSRIs for 8 weeks. Comparison between the two groups will be performed through biochemical
      parameters of oxidative stress markers such as serum malondialdehyde (MDA), serum reduced
      glutathione (GSH) and serum vitamin C levels at baseline (before vitamin C administration)
      and 8 weeks after intervention by vitamin C. Along with the biochemical parameters,
      Yale-Brown score of obsessive-compulsive disorders (Y-OCD) would also be assessed by
      Yale-Brown Obsessive Compulsive Scale (Y-BOCS).Data would be analyzed by Scientific Package
      for Social Science(SPSS) and represented by tables and figures as applicable. Significance
      level would be set at 0.05, 0.01 and 0.001. Patient's data will be recorded in a
      predetermined data sheet. Patients will be informed about the study in easy language and then
      informed consent will be taken. This study has no potential risk to the patients. Hence, this
      study would be the first to examine the efficacy of vitamin C as an adjunct to SSRIs in the
      treatment of OCD.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: To examine the effect of vitamin C upon Selective Serotonin Reuptake Inhibitors (SSRIs) - treated Obsessive Compulsive Disorder patients.
time frame: 8 weeks
description: To assess the clinical improvement of OCD patients by Yale-Brown Obsessive Compulsive Scale (Y-BOCS) and compare plasma MDA, RBC glutathione, plasma vitamin C levels at baseline and after 8 weeks of treatment.
arm group label: Patients receiving SSRIs
arm group type: No Intervention
description: This group will be receive SSRIs only
arm group label: Patients receiving Vitamin C with SSRIs
arm group type: Active Comparator
description: This group will be receive vitamin C (500mg) twice daily with SSRIs for 8 weeks
intervention type: Dietary Supplement
intervention name: Vitamin C
description: One tablet of Vitamin C (500 mg) twice daily with SSRIs for 8 weeks
arm group label: Patients receiving Vitamin C with SSRIs
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Taslima Akter, MBBS
phone: 01738248318
email: taslimamostafij@gmail.com
last name: RAM Mostafizur Rashid, MBBS
phone: 01724840401
email: mostafizrmc@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Bangladesh
responsible party type: Principal Investigator
investigator affiliation: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
investigator full name: Dr.Taslima Akter
investigator title: MD, Resident