<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/NCT03265340</url>
  </required_header>
  <id_info>
    <org_study_id>dTMS dos-respons studie</org_study_id>
    <nct_id>NCT03265340</nct_id>
  </id_info>
  <brief_title>Clinical Effect of dTMS in Major Depressive Disorder</brief_title>
  <official_title>Clinical Effect of Deep Transcranial Magnetic Stimulation (dTMS) in Three Different Doses for the Treatment of Major Depressive Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Section for Affective Disorders; Northern Stockholm Psychiatry</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Section for Affective Disorders; Northern Stockholm Psychiatry</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aim: To test if there is a relation between deep Transcranial Magnetic Stimulation (dTMS)&#xD;
      dose and clinical effect on Major Depressive Disorder (MDD) Method: 30 patients with moderate&#xD;
      to severe MDD without concurrent medication will be randomised to three different treatment&#xD;
      protocols of dTMS. Symptom severity of MDD will be quantified before, during and after dTMS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      population: inclusion criteria:&#xD;
&#xD;
        1. Ongoing episode of MDD (ICD10 F32.x) according to MINI/SCID1.&#xD;
&#xD;
        2. Montgomery Asberg Depression Rating Scale (MADRS) score 20-60&#xD;
&#xD;
        3. TMS safe exclusion criteria:&#xD;
&#xD;
      1. Bipolar disorder 2. Substance abuse 3. fluoxetine treatment last three weeks 4. Other&#xD;
      major Central Nervous System (CNS) disorder 5. Acute medical disorders 6. previous TMS or&#xD;
      Electro Convulsive Treatment (ECT) &lt;2 months before inclusion&#xD;
&#xD;
      ratings: MADRS at inclusion, baseline, weekly, at last visit Clinical Global Impression&#xD;
      Severity (CGI-S) score at baseline, at last visit Global Self-Evaluation-Memory (GSE-My) at&#xD;
      last visit Alcohol Use Disorder Identification Test (AUDIT-C) at inclusion EuroQual 5&#xD;
      Dimension (EQ5D) at baseline, at last visit Quick Inventory of Depressive Symptomatology Self&#xD;
      Rating (QIDS-SR) baseline, weekly, last visit&#xD;
&#xD;
      condition: Each subject is randomised to condition A, B or C of dTMS (Brainsway): half the&#xD;
      standard protocol (10 min; A), standard protocol (20 min; B) or double standard protocol (40&#xD;
      min, C). 20 treatment sessions/subject. 10 subjects in each group.&#xD;
&#xD;
      Primary endpoint: MADRS at baseline - MADRS at last visit (Intention TO Treat (ITT), Last&#xD;
      Observation Carried Forward (LOCF))&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Montgomery Asberg Depression Rating Scale (MADRS) score</measure>
    <time_frame>baseline to last visit (treatment session 20, an average of four weeks)</time_frame>
    <description>MADRS baseline - MADRS last visit (treatment session 20)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical Global Impression Severity (CGI-S)</measure>
    <time_frame>baseline to last visit (treatment session 20, an average of four weeks)</time_frame>
    <description>CGI-Sbaseline - CGI-S last visit (treatment session 20)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Montgomery Asberg Depression Rating Scale (MADRS) response</measure>
    <time_frame>last visit (treatment session 20, an average of four weeks)</time_frame>
    <description>fraction of subjects with &gt;50% decrease in MADRS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Montgomery Asberg Depression Rating Scale (MADRS) remission</measure>
    <time_frame>last visit (treatment session 20, an average of four weeks)</time_frame>
    <description>fraction of subjects with MADRS &lt;10 points</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>memory objective</measure>
    <time_frame>baseline to last visit (treatment session 20, an average of four weeks)</time_frame>
    <description>CPRS memory item at baseline - CPRS memory item at last visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>memory subjective</measure>
    <time_frame>last visit (treatment session 20, an average of four weeks)</time_frame>
    <description>GSE-my at last visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]</measure>
    <time_frame>baseline to last visit (treatment session 20, an average of four weeks)</time_frame>
    <description>systematic safety evaluation and registration of side effects</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>MAjor Depressive Disorder</condition>
  <arm_group>
    <arm_group_label>A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>dTMS standard protocol 10 min session</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>dTMS standard protocol 20 min session</description>
  </arm_group>
  <arm_group>
    <arm_group_label>C</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>dTMS standard protocol 40 min session</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>dTMS</intervention_name>
    <arm_group_label>A</arm_group_label>
    <arm_group_label>B</arm_group_label>
    <arm_group_label>C</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  see above&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  see above&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>johan lundberg, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Norra Stockholms Psykiatri and Karolinska Institutet</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Norra Stockholms Psykiatri</name>
      <address>
        <city>Stockholm</city>
        <zip>11251</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>October 28, 2016</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>March 11, 2019</last_update_submitted>
  <last_update_submitted_qc>March 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Section for Affective Disorders; Northern Stockholm Psychiatry</investigator_affiliation>
    <investigator_full_name>Johan Lundberg</investigator_full_name>
    <investigator_title>Section head, associate professor, MD PhD</investigator_title>
  </responsible_party>
  <keyword>Transcranial Magnetic Stimulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder, Major</mesh_term>
  </condition_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/NCT03265340
org study id: dTMS dos-respons studie
nct id: NCT03265340
lead sponsor: 
has dmc: No
Aim: To test if there is a relation between deep Transcranial Magnetic Stimulation (dTMS)
      dose and clinical effect on Major Depressive Disorder (MDD) Method: 30 patients with moderate
      to severe MDD without concurrent medication will be randomised to three different treatment
      protocols of dTMS. Symptom severity of MDD will be quantified before, during and after dTMS.
population: inclusion criteria:

        1. Ongoing episode of MDD (ICD10 F32.x) according to MINI/SCID1.

        2. Montgomery Asberg Depression Rating Scale (MADRS) score 20-60

        3. TMS safe exclusion criteria:

      1. Bipolar disorder 2. Substance abuse 3. fluoxetine treatment last three weeks 4. Other
      major Central Nervous System (CNS) disorder 5. Acute medical disorders 6. previous TMS or
      Electro Convulsive Treatment (ECT) <2 months before inclusion

      ratings: MADRS at inclusion, baseline, weekly, at last visit Clinical Global Impression
      Severity (CGI-S) score at baseline, at last visit Global Self-Evaluation-Memory (GSE-My) at
      last visit Alcohol Use Disorder Identification Test (AUDIT-C) at inclusion EuroQual 5
      Dimension (EQ5D) at baseline, at last visit Quick Inventory of Depressive Symptomatology Self
      Rating (QIDS-SR) baseline, weekly, last visit

      condition: Each subject is randomised to condition A, B or C of dTMS (Brainsway): half the
      standard protocol (10 min; A), standard protocol (20 min; B) or double standard protocol (40
      min, C). 20 treatment sessions/subject. 10 subjects in each group.

      Primary endpoint: MADRS at baseline - MADRS at last visit (Intention TO Treat (ITT), Last
      Observation Carried Forward (LOCF))
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Montgomery Asberg Depression Rating Scale (MADRS) score
time frame: baseline to last visit (treatment session 20, an average of four weeks)
description: MADRS baseline - MADRS last visit (treatment session 20)
measure: Clinical Global Impression Severity (CGI-S)
time frame: baseline to last visit (treatment session 20, an average of four weeks)
description: CGI-Sbaseline - CGI-S last visit (treatment session 20)
measure: Montgomery Asberg Depression Rating Scale (MADRS) response
time frame: last visit (treatment session 20, an average of four weeks)
description: fraction of subjects with >50% decrease in MADRS
measure: Montgomery Asberg Depression Rating Scale (MADRS) remission
time frame: last visit (treatment session 20, an average of four weeks)
description: fraction of subjects with MADRS <10 points
measure: memory objective
time frame: baseline to last visit (treatment session 20, an average of four weeks)
description: CPRS memory item at baseline - CPRS memory item at last visit
measure: memory subjective
time frame: last visit (treatment session 20, an average of four weeks)
description: GSE-my at last visit
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
time frame: baseline to last visit (treatment session 20, an average of four weeks)
description: systematic safety evaluation and registration of side effects
arm group label: A
arm group type: Active Comparator
description: dTMS standard protocol 10 min session
arm group label: B
arm group type: Active Comparator
description: dTMS standard protocol 20 min session
arm group label: C
arm group type: Active Comparator
description: dTMS standard protocol 40 min session
intervention type: Device
intervention name: dTMS
arm group label: A
arm group label: B
arm group label: C
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: johan lundberg, MD PhD
role: Principal Investigator
affiliation: Norra Stockholms Psykiatri and Karolinska Institutet
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Section for Affective Disorders; Northern Stockholm Psychiatry
investigator full name: Johan Lundberg
investigator title: Section head, associate professor, MD PhD
mesh term: Depressive Disorder
mesh term: Depression
mesh term: Depressive Disorder, Major
sharing ipd: No