<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/NCT03807882</url>
  </required_header>
  <id_info>
    <org_study_id>T/IM-F/18-19/08</org_study_id>
    <nct_id>NCT03807882</nct_id>
  </id_info>
  <brief_title>Comparison of Maintenance ECT Versus Clozapine in Treatment-resistant Schizophrenia</brief_title>
  <official_title>Comparison of Maintenance ECT Versus Clozapine on Psychopathology and Cerebral Hemodynamics in Treatment-resistant Schizophrenia: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>All India Institute of Medical Sciences, Bhubaneswar</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>All India Institute of Medical Sciences, Bhubaneswar</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The proposed study will be conducted to compare the efficacy of maintenance ECT (M-ECT) vs&#xD;
      Clozapine in treatment resistant schizophrenia (TRS) in terms of change in psychopathology&#xD;
      measures and cerebral hemodynamics.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed study is a prospective, randomized clinical trial in patients suffering from&#xD;
      treatment-resistant schizophrenia (TRS) and will be conducted in the Department of&#xD;
      Psychiatry, AIIMS, Bhubaneswar, over a period of 16 months. Sixty patients with TRS (TRRIP&#xD;
      consensus criteria, 2017), fulfilling the inclusion and exclusion criteria will be recruited&#xD;
      for the study. Written informed consent will be taken after explaining the objectives and&#xD;
      procedure of the study in detail. The detailed history, relevant social-demographic and&#xD;
      clinical data will be collected in a structured case record form (CRF). At baseline, PANSS&#xD;
      will be administered to determine the severity of positive symptoms, negative symptoms, and&#xD;
      general psychopathology, Global assessment of functioning (GAF), and CGI to determine the&#xD;
      baseline severity of the illness and improvement with treatment and MoCA to assess change in&#xD;
      cognitive impairment. Before starting the treatment, brain SPECT-CT will be done to measure&#xD;
      baseline regional brain blood perfusion. The study cohort will be randomized into two&#xD;
      treatment groups by computer-generated random numbers, each group comprising 30 patients. One&#xD;
      group will receive maintenance ECT (M-ECT) following acute treatment of bilateral ECT of six&#xD;
      sessions along with ongoing antipsychotic and the other group will be treated with Clozapine&#xD;
      monotherapy. PANSS, GAF, CGI, MoCA will be re-administered at 6 weeks, 3 months, and 6 months&#xD;
      follow-up visits to compare the changes within each group and between the groups.&#xD;
      Post-treatment SPECT-CT of the brain will be done at the end of 6 months to document changes&#xD;
      in the regional cerebral blood perfusion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">June 30, 2020</completion_date>
  <primary_completion_date type="Actual">May 31, 2020</primary_completion_date>
  <phase>Phase 4</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in severity of psychopathology</measure>
    <time_frame>24 weeks</time_frame>
    <description>Severity will be assessed by Positive and Negative Symptom Scale (PANSS) PANSS Score ranges from 30- 210. A higher score represents more severe psychopathology</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in illness severity, and global improvement with treatment</measure>
    <time_frame>24 weeks</time_frame>
    <description>Assessed by change in Clinical Global Impression Schizophrenia (CGI-SCH) scores.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in global functionality</measure>
    <time_frame>24 weeks</time_frame>
    <description>Assessed by change in Global assessment of functioning (GAF) scores.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Cognitive impairment</measure>
    <time_frame>24 weeks</time_frame>
    <description>Assessed by change in Montreal Cognitive Assessment (MoCA) scores.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients receiving rescue medications.</measure>
    <time_frame>24 weeks</time_frame>
    <description>Patients with &quot;treatment relapse&quot; or &quot;treatment non-response&quot; will receive rescue medications.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in regional cerebral blood flow</measure>
    <time_frame>24 weeks</time_frame>
    <description>Change in regional cerebral blood flow will be measured by SPECT-CT Brain</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Treatment Resistant Schizophrenia</condition>
  <arm_group>
    <arm_group_label>Test group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Bilateral Maintenance ECT (B/L M-ECT)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Clozapine monotherapy. Clozapine will be given in accordance with Maudsley guideline: 12.5 mg on the first day, followed by 12.5mg twice daily on the second day, followed by 25mg twice daily for next two days and then increment of 25mg every two days till the target dose of 250-400 mg per day in two divided doses as per tolerability of the patients</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Bilateral M-ECT</intervention_name>
    <description>Following acute treatment with bilateral ECT of 6 sessions over a period of two weeks, Bilateral M-ECT will be administered at a frequency of 1 session/week for one month, then 1 session / 2 weeks for 2 months and then 1 session/month for next 3 months.</description>
    <arm_group_label>Test group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Clozapine</intervention_name>
    <description>Clozapine will be given in accordance with Maudsley guideline: 12.5 mg on the first day, followed by 12.5mg twice daily on the second day, followed by 25mg twice daily for next two days and then increment of 25mg every two days till the target dose of 250-400 mg per day in two divided doses as per tolerability of the patients</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients clinically diagnosed with treatment-resistant schizophrenia (TRS) (TRRIP&#xD;
             consensus criteria).&#xD;
&#xD;
          -  Patients aged 18-60 years of either sex.&#xD;
&#xD;
          -  Patients giving voluntary written consent for participation in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient already on Clozapine or ECT.&#xD;
&#xD;
          -  History of psychoactive substance abuse or dependence.&#xD;
&#xD;
          -  Co-morbid psychiatric, major medical, or neurological disorders.&#xD;
&#xD;
          -  History of organicity or significant head injury.&#xD;
&#xD;
          -  Pacemaker or metal in any part of the body excluding the mouth.&#xD;
&#xD;
          -  Pregnant and breastfeeding females.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>RITUPARNA MAITI, M.D</last_name>
    <role>Study Chair</role>
    <affiliation>AIIMS Bhubaneswar</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dept of Psychiatry, Aiims, Bhubaneswar</name>
      <address>
        <city>Bhubaneswar</city>
        <state>Odisha</state>
        <zip>751019</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <results_reference>
    <citation>Kane JM. Management strategies for the treatment of schizophrenia. J Clin Psychiatry. 1999;60 Suppl 12:13-7.</citation>
    <PMID>10372604</PMID>
  </results_reference>
  <results_reference>
    <citation>Lieberman JA. Maximizing clozapine therapy: managing side effects. J Clin Psychiatry. 1998;59 Suppl 3:38-43.</citation>
    <PMID>9541337</PMID>
  </results_reference>
  <results_reference>
    <citation>Kim HS, Kim SH, Lee NY, Youn T, Lee JH, Chung S, Kim YS, Chung IW. Effectiveness of Electroconvulsive Therapy Augmentation on Clozapine-Resistant Schizophrenia. Psychiatry Investig. 2017 Jan;14(1):58-62. doi: 10.4306/pi.2017.14.1.58. Epub 2016 Dec 29.</citation>
    <PMID>28096876</PMID>
  </results_reference>
  <results_reference>
    <citation>Rey JM, Walter G. Half a century of ECT use in young people. Am J Psychiatry. 1997 May;154(5):595-602. doi: 10.1176/ajp.154.5.595.</citation>
    <PMID>9137112</PMID>
  </results_reference>
  <results_reference>
    <citation>Chanpattana W, Andrade C. ECT for treatment-resistant schizophrenia: a response from the far East to the UK. NICE report. J ECT. 2006 Mar;22(1):4-12. doi: 10.1097/00124509-200603000-00002.</citation>
    <PMID>16633199</PMID>
  </results_reference>
  <results_reference>
    <citation>Chanpattana W, Chakrabhand ML, Sackeim HA, Kitaroonchai W, Kongsakon R, Techakasem P, Buppanharun W, Tuntirungsee Y, Kirdcharoen N. Continuation ECT in treatment-resistant schizophrenia: a controlled study. J ECT. 1999 Sep;15(3):178-92.</citation>
    <PMID>10492856</PMID>
  </results_reference>
  <results_reference>
    <citation>Shimizu E, Imai M, Fujisaki M, Shinoda N, Handa S, Watanabe H, Nakazato M, Hashimoto K, Iyo M. Maintenance electroconvulsive therapy (ECT) for treatment-resistant disorganized schizophrenia. Prog Neuropsychopharmacol Biol Psychiatry. 2007 Mar 30;31(2):571-3. doi: 10.1016/j.pnpbp.2006.11.014. Epub 2006 Dec 20.</citation>
    <PMID>17187911</PMID>
  </results_reference>
  <results_reference>
    <citation>Grover S, Hazari N, Kate N. Combined use of clozapine and ECT: a review. Acta Neuropsychiatr. 2015 Jun;27(3):131-42. doi: 10.1017/neu.2015.8. Epub 2015 Feb 20.</citation>
    <PMID>25697225</PMID>
  </results_reference>
  <results_reference>
    <citation>Petrides G, Malur C, Braga RJ, Bailine SH, Schooler NR, Malhotra AK, Kane JM, Sanghani S, Goldberg TE, John M, Mendelowitz A. Electroconvulsive therapy augmentation in clozapine-resistant schizophrenia: a prospective, randomized study. Am J Psychiatry. 2015 Jan;172(1):52-8. doi: 10.1176/appi.ajp.2014.13060787. Epub 2014 Oct 31.</citation>
    <PMID>25157964</PMID>
  </results_reference>
  <results_reference>
    <citation>Lally J, Tully J, Robertson D, Stubbs B, Gaughran F, MacCabe JH. Augmentation of clozapine with electroconvulsive therapy in treatment resistant schizophrenia: A systematic review and meta-analysis. Schizophr Res. 2016 Mar;171(1-3):215-24. doi: 10.1016/j.schres.2016.01.024. Epub 2016 Jan 27.</citation>
    <PMID>26827129</PMID>
  </results_reference>
  <results_reference>
    <citation>Siskind DJ, Lee M, Ravindran A, Zhang Q, Ma E, Motamarri B, Kisely S. Augmentation strategies for clozapine refractory schizophrenia: A systematic review and meta-analysis. Aust N Z J Psychiatry. 2018 Aug;52(8):751-767. doi: 10.1177/0004867418772351. Epub 2018 May 6.</citation>
    <PMID>29732913</PMID>
  </results_reference>
  <results_reference>
    <citation>Santra A, Kumar R. Brain perfusion single photon emission computed tomography in major psychiatric disorders: From basics to clinical practice. Indian J Nucl Med. 2014 Oct;29(4):210-21. doi: 10.4103/0972-3919.142622.</citation>
    <PMID>25400359</PMID>
  </results_reference>
  <results_reference>
    <citation>Ertugrul A, Volkan-Salanci B, Basar K, Karli Oguz K, Demir B, Ergun EL, Senturk S, Erbas B, Cila A, Ulug B. The effect of clozapine on regional cerebral blood flow and brain metabolite ratios in schizophrenia: relationship with treatment response. Psychiatry Res. 2009 Nov 30;174(2):121-9. doi: 10.1016/j.pscychresns.2009.04.007. Epub 2009 Oct 17.</citation>
    <PMID>19837567</PMID>
  </results_reference>
  <results_reference>
    <citation>Novak B, Milcinski M, Grmek M, Kocmur M. Early effects of treatment on regional cerebral blood flow in first episode schizophrenia patients evaluated with 99Tc-ECD-SPECT. Neuro Endocrinol Lett. 2005 Dec;26(6):685-9.</citation>
    <PMID>16380684</PMID>
  </results_reference>
  <results_reference>
    <citation>Sharafi M. Comparison of Classical and Clozapine Treatment on Schizophrenia Using Positive and Negative Syndrome Scale of Schizophrenia (PANSS) and SPECT Imaging. Int J Med Sci. 2005;2(2):79-86. doi: 10.7150/ijms.2.79. Epub 2005 May 10.</citation>
    <PMID>15968344</PMID>
  </results_reference>
  <results_reference>
    <citation>Howes OD, McCutcheon R, Agid O, de Bartolomeis A, van Beveren NJ, Birnbaum ML, Bloomfield MA, Bressan RA, Buchanan RW, Carpenter WT, Castle DJ, Citrome L, Daskalakis ZJ, Davidson M, Drake RJ, Dursun S, Ebdrup BH, Elkis H, Falkai P, Fleischacker WW, Gadelha A, Gaughran F, Glenthoj BY, Graff-Guerrero A, Hallak JE, Honer WG, Kennedy J, Kinon BJ, Lawrie SM, Lee J, Leweke FM, MacCabe JH, McNabb CB, Meltzer H, Moller HJ, Nakajima S, Pantelis C, Reis Marques T, Remington G, Rossell SL, Russell BR, Siu CO, Suzuki T, Sommer IE, Taylor D, Thomas N, Ucok A, Umbricht D, Walters JT, Kane J, Correll CU. Treatment-Resistant Schizophrenia: Treatment Response and Resistance in Psychosis (TRRIP) Working Group Consensus Guidelines on Diagnosis and Terminology. Am J Psychiatry. 2017 Mar 1;174(3):216-229. doi: 10.1176/appi.ajp.2016.16050503. Epub 2016 Dec 6.</citation>
    <PMID>27919182</PMID>
  </results_reference>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>November 28, 2018</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>June 11, 2021</last_update_submitted>
  <last_update_submitted_qc>June 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>All India Institute of Medical Sciences, Bhubaneswar</investigator_affiliation>
    <investigator_full_name>BISWA RANJAN MISHRA</investigator_full_name>
    <investigator_title>ADDITIONAL PROFESSOR</investigator_title>
  </responsible_party>
  <keyword>M-ECT</keyword>
  <keyword>Clozapine</keyword>
  <keyword>Psychopathology</keyword>
  <keyword>Cerebral perfusion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
    <mesh_term>Schizophrenia, Treatment-Resistant</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Clozapine</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/NCT03807882
org study id: T/IM-F/18-19/08
nct id: NCT03807882
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The proposed study will be conducted to compare the efficacy of maintenance ECT (M-ECT) vs
      Clozapine in treatment resistant schizophrenia (TRS) in terms of change in psychopathology
      measures and cerebral hemodynamics.
The proposed study is a prospective, randomized clinical trial in patients suffering from
      treatment-resistant schizophrenia (TRS) and will be conducted in the Department of
      Psychiatry, AIIMS, Bhubaneswar, over a period of 16 months. Sixty patients with TRS (TRRIP
      consensus criteria, 2017), fulfilling the inclusion and exclusion criteria will be recruited
      for the study. Written informed consent will be taken after explaining the objectives and
      procedure of the study in detail. The detailed history, relevant social-demographic and
      clinical data will be collected in a structured case record form (CRF). At baseline, PANSS
      will be administered to determine the severity of positive symptoms, negative symptoms, and
      general psychopathology, Global assessment of functioning (GAF), and CGI to determine the
      baseline severity of the illness and improvement with treatment and MoCA to assess change in
      cognitive impairment. Before starting the treatment, brain SPECT-CT will be done to measure
      baseline regional brain blood perfusion. The study cohort will be randomized into two
      treatment groups by computer-generated random numbers, each group comprising 30 patients. One
      group will receive maintenance ECT (M-ECT) following acute treatment of bilateral ECT of six
      sessions along with ongoing antipsychotic and the other group will be treated with Clozapine
      monotherapy. PANSS, GAF, CGI, MoCA will be re-administered at 6 weeks, 3 months, and 6 months
      follow-up visits to compare the changes within each group and between the groups.
      Post-treatment SPECT-CT of the brain will be done at the end of 6 months to document changes
      in the regional cerebral blood perfusion.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in severity of psychopathology
time frame: 24 weeks
description: Severity will be assessed by Positive and Negative Symptom Scale (PANSS) PANSS Score ranges from 30- 210. A higher score represents more severe psychopathology
measure: Change in illness severity, and global improvement with treatment
time frame: 24 weeks
description: Assessed by change in Clinical Global Impression Schizophrenia (CGI-SCH) scores.
measure: Change in global functionality
time frame: 24 weeks
description: Assessed by change in Global assessment of functioning (GAF) scores.
measure: Change in Cognitive impairment
time frame: 24 weeks
description: Assessed by change in Montreal Cognitive Assessment (MoCA) scores.
measure: Number of patients receiving rescue medications.
time frame: 24 weeks
description: Patients with "treatment relapse" or "treatment non-response" will receive rescue medications.
measure: Change in regional cerebral blood flow
time frame: 24 weeks
description: Change in regional cerebral blood flow will be measured by SPECT-CT Brain
arm group label: Test group
arm group type: Experimental
description: Bilateral Maintenance ECT (B/L M-ECT)
arm group label: Control group
arm group type: Active Comparator
description: Clozapine monotherapy. Clozapine will be given in accordance with Maudsley guideline: 12.5 mg on the first day, followed by 12.5mg twice daily on the second day, followed by 25mg twice daily for next two days and then increment of 25mg every two days till the target dose of 250-400 mg per day in two divided doses as per tolerability of the patients
intervention type: Other
intervention name: Bilateral M-ECT
description: Following acute treatment with bilateral ECT of 6 sessions over a period of two weeks, Bilateral M-ECT will be administered at a frequency of 1 session/week for one month, then 1 session / 2 weeks for 2 months and then 1 session/month for next 3 months.
arm group label: Test group
intervention type: Drug
intervention name: Clozapine
description: Clozapine will be given in accordance with Maudsley guideline: 12.5 mg on the first day, followed by 12.5mg twice daily on the second day, followed by 25mg twice daily for next two days and then increment of 25mg every two days till the target dose of 250-400 mg per day in two divided doses as per tolerability of the patients
arm group label: Control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: RITUPARNA MAITI, M.D
role: Study Chair
affiliation: AIIMS Bhubaneswar
facility: 
country: India
citation: Kane JM. Management strategies for the treatment of schizophrenia. J Clin Psychiatry. 1999;60 Suppl 12:13-7.
PMID: 10372604
citation: Lieberman JA. Maximizing clozapine therapy: managing side effects. J Clin Psychiatry. 1998;59 Suppl 3:38-43.
PMID: 9541337
citation: Kim HS, Kim SH, Lee NY, Youn T, Lee JH, Chung S, Kim YS, Chung IW. Effectiveness of Electroconvulsive Therapy Augmentation on Clozapine-Resistant Schizophrenia. Psychiatry Investig. 2017 Jan;14(1):58-62. doi: 10.4306/pi.2017.14.1.58. Epub 2016 Dec 29.
PMID: 28096876
citation: Rey JM, Walter G. Half a century of ECT use in young people. Am J Psychiatry. 1997 May;154(5):595-602. doi: 10.1176/ajp.154.5.595.
PMID: 9137112
citation: Chanpattana W, Andrade C. ECT for treatment-resistant schizophrenia: a response from the far East to the UK. NICE report. J ECT. 2006 Mar;22(1):4-12. doi: 10.1097/00124509-200603000-00002.
PMID: 16633199
citation: Chanpattana W, Chakrabhand ML, Sackeim HA, Kitaroonchai W, Kongsakon R, Techakasem P, Buppanharun W, Tuntirungsee Y, Kirdcharoen N. Continuation ECT in treatment-resistant schizophrenia: a controlled study. J ECT. 1999 Sep;15(3):178-92.
PMID: 10492856
citation: Shimizu E, Imai M, Fujisaki M, Shinoda N, Handa S, Watanabe H, Nakazato M, Hashimoto K, Iyo M. Maintenance electroconvulsive therapy (ECT) for treatment-resistant disorganized schizophrenia. Prog Neuropsychopharmacol Biol Psychiatry. 2007 Mar 30;31(2):571-3. doi: 10.1016/j.pnpbp.2006.11.014. Epub 2006 Dec 20.
PMID: 17187911
citation: Grover S, Hazari N, Kate N. Combined use of clozapine and ECT: a review. Acta Neuropsychiatr. 2015 Jun;27(3):131-42. doi: 10.1017/neu.2015.8. Epub 2015 Feb 20.
PMID: 25697225
citation: Petrides G, Malur C, Braga RJ, Bailine SH, Schooler NR, Malhotra AK, Kane JM, Sanghani S, Goldberg TE, John M, Mendelowitz A. Electroconvulsive therapy augmentation in clozapine-resistant schizophrenia: a prospective, randomized study. Am J Psychiatry. 2015 Jan;172(1):52-8. doi: 10.1176/appi.ajp.2014.13060787. Epub 2014 Oct 31.
PMID: 25157964
citation: Lally J, Tully J, Robertson D, Stubbs B, Gaughran F, MacCabe JH. Augmentation of clozapine with electroconvulsive therapy in treatment resistant schizophrenia: A systematic review and meta-analysis. Schizophr Res. 2016 Mar;171(1-3):215-24. doi: 10.1016/j.schres.2016.01.024. Epub 2016 Jan 27.
PMID: 26827129
citation: Siskind DJ, Lee M, Ravindran A, Zhang Q, Ma E, Motamarri B, Kisely S. Augmentation strategies for clozapine refractory schizophrenia: A systematic review and meta-analysis. Aust N Z J Psychiatry. 2018 Aug;52(8):751-767. doi: 10.1177/0004867418772351. Epub 2018 May 6.
PMID: 29732913
citation: Santra A, Kumar R. Brain perfusion single photon emission computed tomography in major psychiatric disorders: From basics to clinical practice. Indian J Nucl Med. 2014 Oct;29(4):210-21. doi: 10.4103/0972-3919.142622.
PMID: 25400359
citation: Ertugrul A, Volkan-Salanci B, Basar K, Karli Oguz K, Demir B, Ergun EL, Senturk S, Erbas B, Cila A, Ulug B. The effect of clozapine on regional cerebral blood flow and brain metabolite ratios in schizophrenia: relationship with treatment response. Psychiatry Res. 2009 Nov 30;174(2):121-9. doi: 10.1016/j.pscychresns.2009.04.007. Epub 2009 Oct 17.
PMID: 19837567
citation: Novak B, Milcinski M, Grmek M, Kocmur M. Early effects of treatment on regional cerebral blood flow in first episode schizophrenia patients evaluated with 99Tc-ECD-SPECT. Neuro Endocrinol Lett. 2005 Dec;26(6):685-9.
PMID: 16380684
citation: Sharafi M. Comparison of Classical and Clozapine Treatment on Schizophrenia Using Positive and Negative Syndrome Scale of Schizophrenia (PANSS) and SPECT Imaging. Int J Med Sci. 2005;2(2):79-86. doi: 10.7150/ijms.2.79. Epub 2005 May 10.
PMID: 15968344
citation: Howes OD, McCutcheon R, Agid O, de Bartolomeis A, van Beveren NJ, Birnbaum ML, Bloomfield MA, Bressan RA, Buchanan RW, Carpenter WT, Castle DJ, Citrome L, Daskalakis ZJ, Davidson M, Drake RJ, Dursun S, Ebdrup BH, Elkis H, Falkai P, Fleischacker WW, Gadelha A, Gaughran F, Glenthoj BY, Graff-Guerrero A, Hallak JE, Honer WG, Kennedy J, Kinon BJ, Lawrie SM, Lee J, Leweke FM, MacCabe JH, McNabb CB, Meltzer H, Moller HJ, Nakajima S, Pantelis C, Reis Marques T, Remington G, Rossell SL, Russell BR, Siu CO, Suzuki T, Sommer IE, Taylor D, Thomas N, Ucok A, Umbricht D, Walters JT, Kane J, Correll CU. Treatment-Resistant Schizophrenia: Treatment Response and Resistance in Psychosis (TRRIP) Working Group Consensus Guidelines on Diagnosis and Terminology. Am J Psychiatry. 2017 Mar 1;174(3):216-229. doi: 10.1176/appi.ajp.2016.16050503. Epub 2016 Dec 6.
PMID: 27919182
responsible party type: Principal Investigator
investigator affiliation: All India Institute of Medical Sciences, Bhubaneswar
investigator full name: BISWA RANJAN MISHRA
investigator title: ADDITIONAL PROFESSOR
mesh term: Schizophrenia
mesh term: Schizophrenia, Treatment-Resistant
mesh term: Clozapine