<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/NCT02221635</url>
  </required_header>
  <id_info>
    <org_study_id>Yunchun Chen</org_study_id>
    <secondary_id>Xijing H</secondary_id>
    <nct_id>NCT02221635</nct_id>
  </id_info>
  <brief_title>Efficacy of Repetitive Transcranial Magnetic Stimulation in the Prevention of Relapse of Schizoaffective</brief_title>
  <official_title>A Study to Evaluate the Efficacy of Repetitive Transcranial Magnetic Stimulation in the Prevention of Relapse of the Symptoms of Schizoaffective Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xijing Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The No.3 hospital of PLA</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The No.91 hospital of PLA</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>No. 102 Hospital of Chinese People's Liberation Army</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Xijing Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the efficacy of repetitive transcranial magnetic&#xD;
      stimulation in the prevention of relapse of the symptoms of schizoaffective disorder. Primary&#xD;
      Outcome Measures:Time between subject randomization to treatment and the first occurrence of&#xD;
      a relapse during the Relapse Prevention Period. Secondary Outcome Measures: Symptom change as&#xD;
      measured by the Positive and Negative Syndrome Scale (PANSS) total and PANSS factor scores;&#xD;
      Illness severity change as measured by Clinical Global Impression of Severity for depression&#xD;
      (CGI-S-DEP); Change in subject functioning using the Personal and Social Performance Scale;&#xD;
      Change in subject medication satisfaction using the Medication Satisfaction Questionnaire&#xD;
      (MSQ).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Schizoaffective disorder is a chronic illness and generally requires life-long treatment. To&#xD;
      date however, no physical therapy has been evaluated in the maintenance treatment of&#xD;
      schizoaffective disorder. This is a randomized (study drug assigned by chance), double-blind&#xD;
      (neither physician nor patient knows the name of the assigned drug), medication-controlled,&#xD;
      parallel-group, multicenter study to evaluate the efficacy and safety of repetitive&#xD;
      transcranial magnetic stimulation(rTMS), as monotherapy or as an adjunct to antipsychotic,&#xD;
      relative to antipsychotic drugs in delaying the time to relapse in patients with&#xD;
      schizoaffective disorder. Patients with acute symptoms of schizoaffective disorder will be&#xD;
      enrolled. The study will consist of 4 periods: an up to 7 days screening/tolerability period,&#xD;
      a 6-week open-label flexible dose lead-in period, a 6-week open-label fixed dose&#xD;
      stabilization period, and a 12 months double-blind relapse prevention period. Patients&#xD;
      without previous exposure to rTMS will be given 4 to 6 days of rTMS for tolerability testing.&#xD;
      Patients can continue their current antipsychotic drugs through Day-1 (the day before the&#xD;
      start of the study period). During the open-label periods, all patients will be treated with&#xD;
      Risperidone. Patients who meet pre-determined stabilization criteria will be eligible to&#xD;
      enter the double-blind relapse prevention period and will be randomly assigned to either&#xD;
      receive rTMS or rTMS+Risperidone treatment. Efficacy will be evaluated during the study using&#xD;
      a relapse assessment(time between subject randomization to treatment and the first occurrence&#xD;
      of a relapse during the Relapse Prevention Period). Secondary Outcome Measures:Secondary&#xD;
      Outcome Measures: Symptom change as measured by the Positive and Negative Syndrome Scale&#xD;
      (PANSS) total and PANSS factor scores; Illness severity change as measured by Clinical Global&#xD;
      Impression of Severity for depression(CGI-S-DEP); Change in subject functioning using the&#xD;
      Personal and Social Performance Scale; Change in subject medication satisfaction using the&#xD;
      Medication Satisfaction Questionnaire (MSQ). Safety will be assessed throughout the study by&#xD;
      monitoring of adverse events, clinical laboratory tests, electrocardiograms (ECGs), vital&#xD;
      sign measurements (temperature, pulse, and blood pressure), and weight. A 10 milliliter&#xD;
      pharmacogenomic blood sample (sample for DNA research) will be collected from patients who&#xD;
      give separate written informed consent for this part of the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>March 2013</start_date>
  <completion_date type="Anticipated">January 2015</completion_date>
  <primary_completion_date type="Anticipated">December 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Time for relapse</measure>
    <time_frame>Monthly during the 15 month double-blind Relapse Prevention Period.</time_frame>
    <description>Time between subject randomization to treatment and the first occurrence of a relapse during the Relapse Prevention Period.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Positive and Negative Syndrome Scale</measure>
    <time_frame>Up to 15 Months</time_frame>
    <description>Symptom change as measured by the Positive and Negative Syndrome Scale (PANSS) total and PANSS factor scores</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Global Impression of Severity for Schizoaffective Disorder</measure>
    <time_frame>Up to 15 Months</time_frame>
    <description>Illness severity change as measured by Clinical Global Impression of Severity for Schizoaffective Disorder (CGI-S-SCA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Personal and Social Performance Scale</measure>
    <time_frame>Up to 15 Months</time_frame>
    <description>Change in subject functioning using the Personal and Social Performance Scale (PSP)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in mood symptoms</measure>
    <time_frame>Up to 15 Months</time_frame>
    <description>Change in mood symptoms as measured by YMRS (Young Mania Rating Scale,in subjects with YMRS=16 at enrollment) and HAM-D-21) (in subjects with HAM-D-21=16 at enrollment)</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">540</enrollment>
  <condition>Schizoaffective Disorder</condition>
  <arm_group>
    <arm_group_label>rTMS+Risperidone</arm_group_label>
    <description>Intensity of 120% of individually determined motor threshold; frequency : 1 Hz; 360 impulsions; on period : 1 min; off period : 30 s.5 sessions per week for 4-6 weeks,than 2 sessions per week for 2 months, repeat that for 12 months.At the same time,risperidone (2-4mg) was took orally.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Risperidone</arm_group_label>
    <description>Risperidone (2-4mg) was took orally.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>rTMS + risperidone</intervention_name>
    <description>Intensity of 120% of individually determined motor threshold; frequency : 1 Hz; 360 impulsions; on period : 1 min; off period : 30 s.5 sessions per week for 4-6 weeks,than 2 sessions per week for 2 months, repeat that for 12 months. Meanwhile,risperidone (2-4 mg) was took orally.</description>
    <arm_group_label>rTMS+Risperidone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Risperidone</intervention_name>
    <description>Risperidone (2-4 mg) was took orally.</description>
    <arm_group_label>Risperidone</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Ages Eligible for Study: 18 Years to 65 Years Genders Eligible for Study: Both Accepts&#xD;
        Healthy Volunteers: No&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  DSM-IV (Diagnostic and Statistical Manual of Mental Disorders-IV)diagnosis of&#xD;
             schizoaffective disorder&#xD;
&#xD;
          -  Experiencing an acute exacerbation of psychotic symptoms&#xD;
&#xD;
          -  A score of &gt;=4 on at least 3 of the following 7 PANSS items: Delusions (P1),&#xD;
             Hallucinatory behavior (P3), Excitement (P4), Hostility (P7), Tension (G4),&#xD;
             Uncooperativeness (G8), and Poor Impulse Control (G14)&#xD;
&#xD;
          -  A score of &gt;=16 on YMRS and/or a score of &gt;=16 on the HAM-D-21&#xD;
&#xD;
          -  Healthy based on physical examinations, electrocardiogram (ECG), laboratory tests,&#xD;
             medical history, and vital signs measurements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A primary active mental illness diagnosis other than schizoaffective disorder&#xD;
&#xD;
          -  Have attempted suicide within 12 months or are at imminent risk of suicide or violent&#xD;
             behavior&#xD;
&#xD;
          -  Subjects with first episode of psychosis&#xD;
&#xD;
          -  Received electroconvulsive therapy in the past 3 months&#xD;
&#xD;
          -  History of hypersensitivity to or intolerance of paliperidone, risperidone, or 20%&#xD;
             Intralipid (placebo)&#xD;
&#xD;
          -  Received long-acting antipsychotic medication within 2 injection cycles&#xD;
&#xD;
          -  Received therapy with clozapine within 3 months&#xD;
&#xD;
          -  A history of neuroleptic malignant syndrome&#xD;
&#xD;
          -  Previous history of lack of response to antipsychotic medication&#xD;
&#xD;
          -  Subjects receiving therapy with antidepressants or mood stabilizers that has been&#xD;
             initiated and/or changed in dose &lt;30 days prior to screening&#xD;
&#xD;
          -  Receiving therapy with carbamazepine&#xD;
&#xD;
          -  Receiving therapy with monoamine oxidase inhibitors&#xD;
&#xD;
          -  Pregnant, breast-feeding, or planning to become pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tan QingRong, MD</last_name>
    <role>Study Chair</role>
    <affiliation>XiJing Hospital, Xi'An, Shanxi, China</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Qingrong</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <zip>710032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wang Hua Ning, Phd</last_name>
      <phone>8613609161341</phone>
      <email>xskzhu@fmmu.edu.cn</email>
    </contact>
    <investigator>
      <last_name>Wang Hua ning, Phd</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 19, 2012</study_first_submitted>
  <study_first_submitted_qc>August 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2014</study_first_posted>
  <last_update_submitted>August 18, 2014</last_update_submitted>
  <last_update_submitted_qc>August 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 20, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Schizoaffective Disorder</keyword>
  <keyword>Repetitive transcranial magnetic stimulation (rTMS)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psychotic Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Risperidone</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/NCT02221635
org study id: Yunchun Chen
secondary id: Xijing H
nct id: NCT02221635
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of this study is to evaluate the efficacy of repetitive transcranial magnetic
      stimulation in the prevention of relapse of the symptoms of schizoaffective disorder. Primary
      Outcome Measures:Time between subject randomization to treatment and the first occurrence of
      a relapse during the Relapse Prevention Period. Secondary Outcome Measures: Symptom change as
      measured by the Positive and Negative Syndrome Scale (PANSS) total and PANSS factor scores;
      Illness severity change as measured by Clinical Global Impression of Severity for depression
      (CGI-S-DEP); Change in subject functioning using the Personal and Social Performance Scale;
      Change in subject medication satisfaction using the Medication Satisfaction Questionnaire
      (MSQ).
Schizoaffective disorder is a chronic illness and generally requires life-long treatment. To
      date however, no physical therapy has been evaluated in the maintenance treatment of
      schizoaffective disorder. This is a randomized (study drug assigned by chance), double-blind
      (neither physician nor patient knows the name of the assigned drug), medication-controlled,
      parallel-group, multicenter study to evaluate the efficacy and safety of repetitive
      transcranial magnetic stimulation(rTMS), as monotherapy or as an adjunct to antipsychotic,
      relative to antipsychotic drugs in delaying the time to relapse in patients with
      schizoaffective disorder. Patients with acute symptoms of schizoaffective disorder will be
      enrolled. The study will consist of 4 periods: an up to 7 days screening/tolerability period,
      a 6-week open-label flexible dose lead-in period, a 6-week open-label fixed dose
      stabilization period, and a 12 months double-blind relapse prevention period. Patients
      without previous exposure to rTMS will be given 4 to 6 days of rTMS for tolerability testing.
      Patients can continue their current antipsychotic drugs through Day-1 (the day before the
      start of the study period). During the open-label periods, all patients will be treated with
      Risperidone. Patients who meet pre-determined stabilization criteria will be eligible to
      enter the double-blind relapse prevention period and will be randomly assigned to either
      receive rTMS or rTMS+Risperidone treatment. Efficacy will be evaluated during the study using
      a relapse assessment(time between subject randomization to treatment and the first occurrence
      of a relapse during the Relapse Prevention Period). Secondary Outcome Measures:Secondary
      Outcome Measures: Symptom change as measured by the Positive and Negative Syndrome Scale
      (PANSS) total and PANSS factor scores; Illness severity change as measured by Clinical Global
      Impression of Severity for depression(CGI-S-DEP); Change in subject functioning using the
      Personal and Social Performance Scale; Change in subject medication satisfaction using the
      Medication Satisfaction Questionnaire (MSQ). Safety will be assessed throughout the study by
      monitoring of adverse events, clinical laboratory tests, electrocardiograms (ECGs), vital
      sign measurements (temperature, pulse, and blood pressure), and weight. A 10 milliliter
      pharmacogenomic blood sample (sample for DNA research) will be collected from patients who
      give separate written informed consent for this part of the study.
observational model: Case-Control
time perspective: Retrospective
measure: Time for relapse
time frame: Monthly during the 15 month double-blind Relapse Prevention Period.
description: Time between subject randomization to treatment and the first occurrence of a relapse during the Relapse Prevention Period.
measure: Positive and Negative Syndrome Scale
time frame: Up to 15 Months
description: Symptom change as measured by the Positive and Negative Syndrome Scale (PANSS) total and PANSS factor scores
measure: Clinical Global Impression of Severity for Schizoaffective Disorder
time frame: Up to 15 Months
description: Illness severity change as measured by Clinical Global Impression of Severity for Schizoaffective Disorder (CGI-S-SCA)
measure: Personal and Social Performance Scale
time frame: Up to 15 Months
description: Change in subject functioning using the Personal and Social Performance Scale (PSP)
measure: Change in mood symptoms
time frame: Up to 15 Months
description: Change in mood symptoms as measured by YMRS (Young Mania Rating Scale,in subjects with YMRS=16 at enrollment) and HAM-D-21) (in subjects with HAM-D-21=16 at enrollment)
arm group label: rTMS+Risperidone
description: Intensity of 120% of individually determined motor threshold; frequency : 1 Hz; 360 impulsions; on period : 1 min; off period : 30 s.5 sessions per week for 4-6 weeks,than 2 sessions per week for 2 months, repeat that for 12 months.At the same time,risperidone (2-4mg) was took orally.
arm group label: Risperidone
description: Risperidone (2-4mg) was took orally.
intervention type: Procedure
intervention name: rTMS + risperidone
description: Intensity of 120% of individually determined motor threshold; frequency : 1 Hz; 360 impulsions; on period : 1 min; off period : 30 s.5 sessions per week for 4-6 weeks,than 2 sessions per week for 2 months, repeat that for 12 months. Meanwhile,risperidone (2-4 mg) was took orally.
arm group label: rTMS+Risperidone
intervention type: Drug
intervention name: Risperidone
description: Risperidone (2-4 mg) was took orally.
arm group label: Risperidone
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Tan QingRong, MD
role: Study Chair
affiliation: XiJing Hospital, Xi'An, Shanxi, China
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Sponsor
mesh term: Psychotic Disorders
mesh term: Risperidone