<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/NCT03254342</url>
  </required_header>
  <id_info>
    <org_study_id>28162</org_study_id>
    <nct_id>NCT03254342</nct_id>
  </id_info>
  <brief_title>MRS and Medication Response: A Pilot Study</brief_title>
  <official_title>Magnetic Resonance Spectroscopy and Medication Response: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
  </oversight_info>
  <brief_summary>
    <textblock>
      We hope to demonstrate that magnetic resonance spectroscopy can detect brain concentration&#xD;
      levels of paroxetine (Paxil) or citalopram (Celexa) or escitalopram (Lexapro) in depressed&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of this study is to demonstrate that it is feasible to image paroxetine&#xD;
      (Paxil) or citalopram (Celexa) or escitalopram (Lexapro) brain concentrations using MRS&#xD;
      technology in depressed patients.&#xD;
&#xD;
      The longer-term goal is to determine the relationship between clinically administered doses&#xD;
      of paroxetine (Paxil) or citalopram (Celexa) or escitalopram (Lexapro) (antidepressants), the&#xD;
      amount of drug in the body via blood level, the concentrations of the drug achieved in brain&#xD;
      measured via MRS, and genetics.&#xD;
&#xD;
      It has been previously reported that individuals taking 20mg of paroxetine daily had brain&#xD;
      paroxetine [(Paxil) levels via MRS ranging from 2-13 micromolar. Similar or slightly higher&#xD;
      ranges of brain drug concentrations have been reported for fluoxetine and fluvoxamine.&#xD;
&#xD;
      Since not all depressed patients respond to medications, one reason may be the amount of&#xD;
      medication that crosses the blood-brain barrier. This may be influenced by genetic&#xD;
      information. We want to examine these issues on a larger scale, but first we need to&#xD;
      demonstrate that we can indeed determine paroxetine [(Paxil) or citalopram (Celexa) or&#xD;
      escitalopram (Lexapro)] levels via MRS.&#xD;
&#xD;
      Intended results analysis could not be conducted because a reliably sensitive spectroscopic&#xD;
      method could not be developed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Unable to obtain a reliable MRS signal&#xD;
  </why_stopped>
  <start_date type="Actual">August 6, 2013</start_date>
  <completion_date type="Actual">August 31, 2020</completion_date>
  <primary_completion_date type="Actual">August 6, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Measurement of paroxetine (Paxil), citalopram (Celexa) or escitalopram (Lexapro) brain concentrations.</measure>
    <time_frame>Within 7 Days following MRS</time_frame>
    <description>Measurement of paroxetine (Paxil), citalopram (Celexa) or escitalopram (Lexapro) brain concentrations using MRS technology in depressed participants.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">3</enrollment>
  <condition>Major Depressive Disorder</condition>
  <condition>Major Depressive Episode</condition>
  <condition>Major Depressive Disorder, Recurrent</condition>
  <condition>Major Depression Mild</condition>
  <condition>Major Depression Moderate</condition>
  <condition>Major Depression Severe</condition>
  <arm_group>
    <arm_group_label>Major depressive disorder</arm_group_label>
    <description>There is no intervention/treatment in this study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-depressed individuals</arm_group_label>
    <description>There is no intervention/treatment in this study.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Psychiatry clinic; local community.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Major depressive disorder:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          1. DSM diagnosis of Major Depressive Disorder&#xD;
&#xD;
          2. Taking paroxetine [(Paxil) or citalopram (Celexa) or escitalopram (Lexapro)]for at&#xD;
             least 6 weeks&#xD;
&#xD;
          3. Between 21 - 75 years of age.&#xD;
&#xD;
          4. Taking a stable dose of paroxetine [(Paxil) or citalopram (Celexa) or escitalopram&#xD;
             (Lexapro)] for at least the 2 weeks prior to the imaging session&#xD;
&#xD;
        Healthy controls:&#xD;
&#xD;
          1. Between 21 - 75 years of age.&#xD;
&#xD;
          2. Have a 21-item HAM-D score of less than or equal to 5.&#xD;
&#xD;
          3. No current, or history of any Axis I disorder.&#xD;
&#xD;
        Identify exclusion criteria.&#xD;
&#xD;
        Exclusion criteria are as follows:&#xD;
&#xD;
          1. Contraindications for an MRI exam. These includes biomedical devices such as&#xD;
             pacemakers, aneurysm clips, prostheses, and other metallic objects embedded in the&#xD;
             body such as bullets, buckshot, shrapnel, and any metal fragments from working around&#xD;
             metal.&#xD;
&#xD;
          2. Current pregnancy or lactation.&#xD;
&#xD;
          3. Patients with claustrophobia.&#xD;
&#xD;
          4. History, or current Axis I or Axis II disorders&#xD;
&#xD;
          5. Active unstable medical problems, as confirmed by screening procedures&#xD;
&#xD;
          6. Diagnosed with any autoimmune disease, (e.g., rheumatoid arthritis, Lupus, MLS).&#xD;
&#xD;
          7. Chronic use of steroids or opiates.&#xD;
&#xD;
          8. Positive urine toxicology screen for illicit substances of abuse.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Stanford University Psychiatry and Biobehavioral Sciences</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>August 16, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <last_update_submitted>August 12, 2021</last_update_submitted>
  <last_update_submitted_qc>August 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 19, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Alan Schatzberg</investigator_full_name>
    <investigator_title>Professor, Department of Psychiatry and Behavioral Sciences</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Depressive Disorder, Major</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Currently there is no plan.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
  </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/NCT03254342
org study id: 28162
nct id: NCT03254342
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
We hope to demonstrate that magnetic resonance spectroscopy can detect brain concentration
      levels of paroxetine (Paxil) or citalopram (Celexa) or escitalopram (Lexapro) in depressed
      patients.
The primary objective of this study is to demonstrate that it is feasible to image paroxetine
      (Paxil) or citalopram (Celexa) or escitalopram (Lexapro) brain concentrations using MRS
      technology in depressed patients.

      The longer-term goal is to determine the relationship between clinically administered doses
      of paroxetine (Paxil) or citalopram (Celexa) or escitalopram (Lexapro) (antidepressants), the
      amount of drug in the body via blood level, the concentrations of the drug achieved in brain
      measured via MRS, and genetics.

      It has been previously reported that individuals taking 20mg of paroxetine daily had brain
      paroxetine [(Paxil) levels via MRS ranging from 2-13 micromolar. Similar or slightly higher
      ranges of brain drug concentrations have been reported for fluoxetine and fluvoxamine.

      Since not all depressed patients respond to medications, one reason may be the amount of
      medication that crosses the blood-brain barrier. This may be influenced by genetic
      information. We want to examine these issues on a larger scale, but first we need to
      demonstrate that we can indeed determine paroxetine [(Paxil) or citalopram (Celexa) or
      escitalopram (Lexapro)] levels via MRS.

      Intended results analysis could not be conducted because a reliably sensitive spectroscopic
      method could not be developed.
observational model: Other
time perspective: Prospective
measure: Measurement of paroxetine (Paxil), citalopram (Celexa) or escitalopram (Lexapro) brain concentrations.
time frame: Within 7 Days following MRS
description: Measurement of paroxetine (Paxil), citalopram (Celexa) or escitalopram (Lexapro) brain concentrations using MRS technology in depressed participants.
arm group label: Major depressive disorder
description: There is no intervention/treatment in this study.
arm group label: Non-depressed individuals
description: There is no intervention/treatment in this study.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Alan Schatzberg
investigator title: Professor, Department of Psychiatry and Behavioral Sciences
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Depressive Disorder, Major
sharing ipd: Yes
ipd description: Currently there is no plan.
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)