<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/NCT02223299</url>
  </required_header>
  <id_info>
    <org_study_id>553Schanzer0002</org_study_id>
    <nct_id>NCT02223299</nct_id>
  </id_info>
  <brief_title>Pilot Study: Combining Nutritional Supplements With Standard Antidepressant to Treat Depression.</brief_title>
  <official_title>A Randomized Double-Blind Placebo-Controlled Pilot Study of L-tyrosine and L-tryptophan in Depressed Patients Receiving L-methylfolate and and SSRI</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>John D. Dingell VA Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>John D. Dingell VA Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      **This study never received IRB approval and no participants were ever enrolled** The purpose&#xD;
      of this study is to determine if adding over the counter nutritional supplements will have a&#xD;
      benefit to participants currently taking prescribed antidepressants who have not experienced&#xD;
      complete remission of their depression symptoms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Inclusion Criteria:&#xD;
&#xD;
      Detroit VA Patients with major depression, mild to moderate treated with an SSRI and not&#xD;
      having complete remission of symptoms as defined by &quot;feeling their normal selves&quot;&#xD;
&#xD;
      Randomized into two groups:&#xD;
&#xD;
      Experimental: will receive month supply of deplin 15mg, L-tyrosine 6g/d into 2 divided doses,&#xD;
      and L-tryptophan 2g/d into 2 divided doses.&#xD;
&#xD;
      Control: will receive month supply of deplin 15mg , and 2 placebo pills.&#xD;
&#xD;
      Beck Depression Scale (BDI-2) to be administered at baseline and every 2 weeks for 1 month.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    The study was never approved by the IRB and the PI left the VA&#xD;
  </why_stopped>
  <start_date type="Actual">November 2015</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">November 2015</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>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Benefit of nutritional supplement</measure>
    <time_frame>30 days</time_frame>
    <description>Through participant interviews and Beck Depression scale determine if adding nutritional supplements improve or resolve complete remission of depression symptoms.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Deplin w Supplements</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>deplin 15mg plus L-Tyrosine 6g/d and L-Tryptophan 2g/d for 30 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Deplin w placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>deplin 15mg daily plus Placebo A and Placebo B for 30 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>L-tyrosine</intervention_name>
    <description>6g/d daily for 30 days</description>
    <arm_group_label>Deplin w Supplements</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>L-Tryptophan</intervention_name>
    <description>2g/d daily for 30 days</description>
    <arm_group_label>Deplin w Supplements</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>deplin</intervention_name>
    <description>15mg daily for 30 days</description>
    <arm_group_label>Deplin w Supplements</arm_group_label>
    <arm_group_label>Deplin w placebo</arm_group_label>
    <other_name>L-methylfolate</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo A</intervention_name>
    <description>a sugar-pill that looks like a real medication</description>
    <arm_group_label>Deplin w placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo B</intervention_name>
    <description>a sugar-pill that looks like a real medication</description>
    <arm_group_label>Deplin w placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        **This study never received IRB approval and no participants were enrolled**&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Veterans Administration Medical Center patients with major depression, mild to&#xD;
             moderate treated with an SSRI and not having complete remission of symptoms.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>John D Dingell VA Medical Center</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201-1916</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>August 19, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2014</study_first_posted>
  <last_update_submitted>February 19, 2020</last_update_submitted>
  <last_update_submitted_qc>February 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Depression</keyword>
  <keyword>SSRI</keyword>
  <keyword>Nutritional Supplements</keyword>
  <keyword>Beck Depression Scale</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tryptophan</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>This study never received IRB approval and never enrolled any participants. ClinicalTrials.gov entry should be removed.</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/NCT02223299
org study id: 553Schanzer0002
nct id: NCT02223299
lead sponsor: 
has dmc: No
**This study never received IRB approval and no participants were ever enrolled** The purpose
      of this study is to determine if adding over the counter nutritional supplements will have a
      benefit to participants currently taking prescribed antidepressants who have not experienced
      complete remission of their depression symptoms.
Inclusion Criteria:

      Detroit VA Patients with major depression, mild to moderate treated with an SSRI and not
      having complete remission of symptoms as defined by "feeling their normal selves"

      Randomized into two groups:

      Experimental: will receive month supply of deplin 15mg, L-tyrosine 6g/d into 2 divided doses,
      and L-tryptophan 2g/d into 2 divided doses.

      Control: will receive month supply of deplin 15mg , and 2 placebo pills.

      Beck Depression Scale (BDI-2) to be administered at baseline and every 2 weeks for 1 month.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Other
masking: Single (Participant)
measure: Benefit of nutritional supplement
time frame: 30 days
description: Through participant interviews and Beck Depression scale determine if adding nutritional supplements improve or resolve complete remission of depression symptoms.
arm group label: Deplin w Supplements
arm group type: Experimental
description: deplin 15mg plus L-Tyrosine 6g/d and L-Tryptophan 2g/d for 30 days
arm group label: Deplin w placebo
arm group type: Placebo Comparator
description: deplin 15mg daily plus Placebo A and Placebo B for 30 days
intervention type: Dietary Supplement
intervention name: L-tyrosine
description: 6g/d daily for 30 days
arm group label: Deplin w Supplements
intervention type: Dietary Supplement
intervention name: L-Tryptophan
description: 2g/d daily for 30 days
arm group label: Deplin w Supplements
intervention type: Drug
intervention name: deplin
description: 15mg daily for 30 days
arm group label: Deplin w Supplements
arm group label: Deplin w placebo
other name: L-methylfolate
intervention type: Other
intervention name: Placebo A
description: a sugar-pill that looks like a real medication
arm group label: Deplin w placebo
intervention type: Other
intervention name: Placebo B
description: a sugar-pill that looks like a real medication
arm group label: Deplin w placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Tryptophan
sharing ipd: No
ipd description: This study never received IRB approval and never enrolled any participants. ClinicalTrials.gov entry should be removed.