<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/NCT03829579</url>
  </required_header>
  <id_info>
    <org_study_id>CR108572</org_study_id>
    <secondary_id>54135419TRD3012</secondary_id>
    <nct_id>NCT03829579</nct_id>
  </id_info>
  <brief_title>Pre-Approval Access to Esketamine Nasal Spray for the Treatment of Treatment-Resistant Depression (TRD)</brief_title>
  <official_title>Esketamine Single Patient Request</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Research &amp; Development, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen Research &amp; Development, LLC</source>
  <brief_summary>
    <textblock>
      This is a pre-approval access program (PAAP) for eligible participants. The main purpose of&#xD;
      this program is to provide access to esketamine nasal spray to eligible participant with&#xD;
      treatment-resistant depression (TRD), who have exhausted all other treatment options,&#xD;
      including all alternative treatment options with marketed therapies.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Approved for marketing</overall_status>
  <study_type>Expanded Access</study_type>
  <expanded_access_info>
    <expanded_access_type_individual>Yes</expanded_access_type_individual>
  </expanded_access_info>
  <condition>Depressive Disorder, Treatment-Resistant</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Esketamine</intervention_name>
    <description>Participants will self-administer esketamine nasal spray, under the supervision of the healthcare professional at the site of care. A starting dose of 56 milligram (mg) will be administered intranasally into each nostril on Day 1 with subsequent doses of 56 mg or 84 mg administered during Weeks 1-4 (2 treatment sessions per week). For participants who respond, treatment is continued as follows: 56 mg or 84 mg of esketamine nasal spray during Weeks 5-8 (once weekly), and Week 9 onwards (every 2 weeks or once weekly), with period re-evaluation to determine the need for continued treatment. Doses will be adjusted based on efficacy and tolerability to the previous dosing.</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must have an unmet medical need to treat treatment-resistant depression (TRD) with&#xD;
             esketamine nasal spray, an investigational compound, that has not been approved by any&#xD;
             health authority. This means no other treatment options are available and the&#xD;
             participant must be unable to participate in a clinical trial; for example, because&#xD;
             they do not fulfill the eligibility criteria of the protocol or there are no trial&#xD;
             sites within a reasonable distance of where they reside&#xD;
&#xD;
          -  Must not participate in a clinical trial or be concurrently treated with an&#xD;
             investigational drug when being treated with esketamine nasal spray&#xD;
&#xD;
          -  Participants must have TRD with the diagnosis verified by a psychiatrist, and have&#xD;
             exhausted all other options including all alternative treatment options with marketed&#xD;
             therapies, specifically:&#xD;
&#xD;
               1. Participant must meet the Diagnostic and Statistical Manual of Mental Disorders&#xD;
                  (DSM)-5 diagnostic criteria for single-episode major depressive episode (major&#xD;
                  depressive disorder [MDD]) (if single-episode MDD, the duration must be greater&#xD;
                  than [&gt;]2 years) or recurrent MDD, without psychotic features.&#xD;
&#xD;
               2. Participant must have had nonresponse to 2 or more oral antidepressant treatments&#xD;
                  in the current episode of depression confirmed by documented medical history&#xD;
                  and/or pharmacy/prescription records to meet criteria for TRD and have failed at&#xD;
                  least one augmentation strategy (for example, atypical antipsychotics such as&#xD;
                  aripiprazole or quetiapine, lithium, thyroid hormones, bupropion, etc) and have&#xD;
                  failed an adequate course (greater than or equal to [&gt;=] 7 unilateral [UL]&#xD;
                  sessions) of, or have a contraindication to electro-convulsive therapy (ECT) and&#xD;
                  transcranial magnetic stimulation (TMS)&#xD;
&#xD;
          -  Participants must have exhausted clinical trials, early access programs or named&#xD;
             patient programs that may be available in their region&#xD;
&#xD;
          -  Participants must have moderate to severe depression per clinical judgment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The participant's depressive symptoms have previously demonstrated nonresponse to&#xD;
             Esketamine Nasal Spray or ketamine in the current major depressive episode per&#xD;
             clinical judgment&#xD;
&#xD;
          -  Participant has a current or prior DSM-5 diagnosis of a psychotic disorder or MDD with&#xD;
             psychosis, bipolar or related disorders, comorbid obsessive- compulsive disorder,&#xD;
             intellectual disability (only DSM-5 diagnostic code 319), borderline personality&#xD;
             disorder, antisocial personality disorder, histrionic personality disorder, or&#xD;
             narcissistic personality disorder&#xD;
&#xD;
          -  Participant has homicidal ideation/intent or has suicidal ideation with some intent to&#xD;
             act within 6 months or a history of suicidal behavior within the past year, per the&#xD;
             requesting psychiatrist's clinical judgment&#xD;
&#xD;
          -  Participant has a history of moderate or severe substance or alcohol use disorder&#xD;
             according to DSM-5 criteria, except nicotine or caffeine, within 6 months before the&#xD;
             start of the first dose.&#xD;
&#xD;
             a) A history (lifetime) of ketamine, phencyclidine (PCP), lysergic acid diethylamide&#xD;
             (LSD), or 3, 4-methylenedioxy-methamphetamine (MDMA) hallucinogen-related use disorder&#xD;
             is exclusionary&#xD;
&#xD;
          -  Participants with a current or past history of seizures (uncomplicated childhood&#xD;
             febrile seizures with no sequelae are not exclusionary)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Janssen Research &amp; Development, LLC Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Research &amp; Development, LLC</affiliation>
  </overall_official>
  <removed_countries>
    <country>France</country>
    <country>Italy</country>
  </removed_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>February 1, 2019</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>February 6, 2020</last_update_submitted>
  <last_update_submitted_qc>February 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Depressive Disorder, Treatment-Resistant</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Esketamine</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03829579
org study id: CR108572
secondary id: 54135419TRD3012
nct id: NCT03829579
lead sponsor: 
This is a pre-approval access program (PAAP) for eligible participants. The main purpose of
      this program is to provide access to esketamine nasal spray to eligible participant with
      treatment-resistant depression (TRD), who have exhausted all other treatment options,
      including all alternative treatment options with marketed therapies.
expanded access type individual: Yes
intervention type: Drug
intervention name: Esketamine
description: Participants will self-administer esketamine nasal spray, under the supervision of the healthcare professional at the site of care. A starting dose of 56 milligram (mg) will be administered intranasally into each nostril on Day 1 with subsequent doses of 56 mg or 84 mg administered during Weeks 1-4 (2 treatment sessions per week). For participants who respond, treatment is continued as follows: 56 mg or 84 mg of esketamine nasal spray during Weeks 5-8 (once weekly), and Week 9 onwards (every 2 weeks or once weekly), with period re-evaluation to determine the need for continued treatment. Doses will be adjusted based on efficacy and tolerability to the previous dosing.
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Janssen Research & Development, LLC Clinical Trial
role: Study Director
affiliation: Janssen Research & Development, LLC
country: France
country: Italy
responsible party type: Sponsor
mesh term: Depressive Disorder
mesh term: Depressive Disorder, Treatment-Resistant
mesh term: Esketamine