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1 Clinical Trial Details (PDF Generation Date :- Fri, 01 Feb :32:33 GMT) CTRI Number CTRI/2011/091/ [Registered on: 20/01/2011] - Last Modified On 23/07/2014 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study No Interventional Drug Randomized, Parallel Group, Placebo Controlled Trial A study to evaluate the efficacy of Paliperidone Palmitate in the Prevention of Relapse of the Symptoms of Schizoaffective Disorder A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Paliperidone Palmitate Evaluating Time to Relapse in Subjects With Schizoaffective Disorder Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) NCT R SCA-3004 Designation Affiliation ClinicalTrials.gov Protocol Number Details of Principal Investigator Details Contact Person (Scientific Query) Details Contact Person (Public Query) Phone Fax Designation Affiliation Details Contact Person (Scientific Query) Dr Shoibal Mukherjee Vice President, Medical Phone Fax Designation Affiliation Quintiles Research (India) Pvt. Ltd. 8th Floor, DLF Square M Block, Jacaranda Marg DLF City Phase II Gurgaon, Haryana India Gurgaon HARYANA India shoibal.mukherjee@quintiles.com Details Contact Person (Public Query) Suchela Srivatsa Director Clinical Operations Phone Quintiles Research (India) Pvt. Ltd. 301-A-1, Leela Business Park MV Road, Andheri East, Mumbai Mumbai MAHARASHTRA India page 1 / 7

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Fax Source of Monetary or Material Support > Ortho-McNeil Janssen Scientific Affairs, LLC 1000 Route 202 South Raritan, NJ 08869, USA Type of Sponsor Quintiles Research India Private Limited List of Countries Bulgaria India Malaysia Philippines Romania Russian Federation Ukraine United States of America of Principal Investigator Dr. Sateesh Rao Dr. Anil Nischal Dr. Sanjay Phadke Dr. Venu Gopal Jhanwar Dr. Sathyanarayana Rao T S Primary Sponsor Details OrthoMcNeil Janssen Scientific Affairs LLC1000 Route 202 South Raritan, NJ 08869, USA Pharmaceutical industry-global B , Shapath IV, Opp. Karnavati Club, Sarkhej Gandhinagar Road, Ahmedabad of Site Site Phone/Fax/ Centre for Psychiatric Research, K.S. Hegde Medical Academy, Mangalore Chhatrapati Shahuji Maharaj (CSM) Medical University, Lucknow Deenanath Mangeshkar Hospital & Reseach Centre, Pune Deva Mental Health Care, Varanasi JSS Medical College & Hospital, Mysore Centre for Psychiatric Research, K.S. Hegde Medical Academy,K.S.Hegde Medical Sciences Complex, Nitte University, Deralakatte, Bangalore KARNATAKA Chhatrapati Shahuji Maharaj (CSM) Medical University,Department of Psychiatry Lucknow UTTAR PRADESH Deenanath Mangeshkar Hospital & Reseach Centre,Erandawane Pune MAHARASHTRA Deva Mental Health Care,B-27/70 MN, Badhal Kothi, Durgakund Varanasi UTTAR PRADESH JSS University, Department of dr_satheeshrao@yahoo.com an.kgmu@gmail.com sanjay_phadke@hotma il.com venugj@gmail.com page 2 / 7

3 Dr Sandeep Shah Dr. Ramnathan Sathianathan Dr. Jitendra Kumar Trivedi Dr. Anil Kumar Tambi Dr. Rakesh Yadav Dr. Hitendra Gandhi Dr. Vinay Barhale Dr. Umesh S Nagapurkar Maanav Health Foundation, C/O Brij Psychiatry Hospital & Muskaan Research Centre Madras Medical College & Government General Hospital, Chennai Manobal Medical Research Centre Pvt. Ltd., Lucknow Mental Health Care & Research, Jaipur R. K. Yadav Memorial Mental Health & De-addiction Hospital, Jaipur Sheth Vadilal Sarabhai General hospital, Ahmedabad Society for Psychiatric Update & research, Shanti Nursing Home, Aurangabad Sujata Birla Hospital and Medical Research Center, Nasik Psychaitry, JSS Medical College & Hospital,Sri Shivaratheeshwara Nagara Mysore KARNATAKA Brij Psychiatry Hospital & Muskaan Research Centre, Bhanu Sadan, Opp. Nimbalkar Chambers, Dandia Bazar, Vadodara Vadodara GUJARAT Madras Medical College & Government General Hospital, Chennai TAMIL NADU Manobal Medical Research Centre Pvt. Ltd.,,B-8, Sector-A, Mahanagar, Lucknow UTTAR PRADESH Mental Health Care & Research,A-500,First Floor, Govind Marg, Malviya Nagar Jaipur RAJASTHAN R. K. Yadav Memorial Mental Health & De-addiction Hospital,B-6, Hanuman Nagar, Main Sirsi Road, Khatipura Jaipur RAJASTHAN Sheth Vadilal Sarabhai General hospital,ellisbri dge Ahmadabad GUJARAT Society for Psychiatric Update & research, Shanti Nursing Home,Kanchanwadi, Paithan Road Aurangabad BIHAR Sujata Birla Hospital and Medical Research Center,Opp. Bytco College, Nashik Road tssrao19@yahoo.com brijclinic@hotmail.com sathianathen6@yahoo. com jitendra.trivedi@gmail.c om dr.tambianil@yahoo.co. in drrakeshyadav@hotmai l.com hitengandhi@yahoo.co. in vinay.barhale@rediffma il.com umeshanjali@gmail.co m page 3 / 7

4 Details of Ethics Committee Dr. Vishal Indla Vijayawada Institute of Mental Health and Neurosciences (VIMHANS) Hospital, Vijayawada Not Applicable N/A Vijayawada Institute of Mental Health and Neurosciences (VIMHANS) Hospital,V.V. Rao Street, Surya Rao Pet, Not Applicable N/A of Committee Approval Status Date of Approval Is Independent Ethics Committee? Central Ethical Committee, Nitte University, Mangalore - Dr. Sateesh Rao DMHC Ethics Committee, Varanasi - Dr. Venu Gopal Jhanwar Ethical Committee - Sheth V S Hospital, Ahmedabad - Dr. Hitendra Gandhi Ethics Committee - Madras Medical College & Government General Hospital, Chennai - Dr. Ramnathan Sathianathan Ethics Committee, Shanti Nursing Home, Aurangabad - Dr. Vinay Barhale Ethics Committee-Jagadguru Sri Shivaratheeshwara Medical College, Mysore - Dr. Sathyanarayana Rao Independent Ethics Committee, Jaipur - Dr. Anil Kumar Tambi Approved 18/11/2010 Not Available Approved 12/11/2010 Not Available Approved 07/03/2011 Not Available Approved 25/10/2010 Not Available Approved 26/02/2011 Not Available Approved 03/11/2010 Not Available Approved 26/10/2010 Not Available Institutional Ethics Committee, Chhatrapati Shahuji Maharaj (CSM) Medical University, Lucknow - Dr. Anil Nischal Approved 10/02/2011 Not Available Institutional Ethics Committee, Deenanath Mangeshkar Hospital & Reseach Centre, Pune - Dr. Sanjay Phadke Lucknow Ethics Committee, Lucknow - Approved 11/01/2012 Not Available Approved 29/01/2011 Not Available page 4 / 7

5 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Dr. Jitendra Kumar Trivedi Maanav Health Foundation Independent Ethics Committee, Vadodara - Dr Sandeep Shah North Maharashtra Ethics Committee, Nashik - Dr. Umesh S Nagapurkar The Ethics Committee, R K Yadav Memorial Mental Health & De-addiction Hospital, Jaipur - Dr. Rakesh Yadav Vijayawada Institute of Mental Health and Neurosciences Hospital-Ethics Committee, Vijayawada- Dr. Vishal Indla Status Approved 01/12/2010 Not Available Approved 30/12/2010 Not Available Approved 15/11/2010 Not Available Approved 12/10/2010 Not Available Date Approved/Obtained 17/01/2011 Health Type Patients Condition Schizoaffective Disorder Type Details Intervention Paliperidone palmitate 78, 117, 156, 234 mg (50, 75, 100 or 150 mg eq.) monthly by i.m. injection for up to 21 months (6 months open-label and 15 months double-blind) Comparator Agent Placebo monthly by i.m. injection for up to 15 months Age From Age To Gender Details Year(s) Year(s) Both Inclusion Criteria - DSM-IV diagnosis of schizoaffective disorder - Experiencing an acute exacerbation of psychotic symptoms - A score of more than or equual to 4 on at least 3 of the following 7 PANSS items: Delusions (P1), Hallucinatory behavior (P3), Excitement (P4), Hostility (P7), Tension (G4), Uncooperativeness (G8), and Poor Impulse Control (G14) - A score of more than or equual to 16 on YMRS and/or a score of more than or equual to 16 on the HAM-D-21 - Healthy based on physical examinations, electrocardiogram (ECG), laboratory tests, medical history, and vital signs measurements Exclusion Criteria Details Exclusion Criteria - A primary active mental illness diagnosis other than schizoaffective disorder - Have attempted suicide within 12 months or are at imminent risk of suicide or violent behavior - Subjects with first page 5 / 7

6 Method of Generating Random Sequence Method of Concealment Blinding/Masking Computer generated randomization Centralized episode of psychosis - Received electroconvulsive therapy in the past 3 months - History of hypersensitivity to or intolerance of paliperidone, risperidone, or 20% Intralipid (placebo) - Received long-acting antipsychotic medication within 2 injection cycles - Received therapy with clozapine within 3 months - A history of neuroleptic malignant syndrome - Previous history of lack of response to antipsychotic medication - Subjects receiving therapy with antidepressants or mood stabilizers that has been initiated and/or changed in dose <30 days prior to screening - Receiving therapy with carbamazepine - Receiving therapy with monoamine oxidase inhibitors - Pregnant, breast-feeding, or planning to become pregnant Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded Primary Outcome Outcome Timepoints Time between subject randomization to treatment and the first occurrence of a relapse during the Relapse Prevention Period Monthly during the 15 month double-blind Relapse Prevention Period Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Phase 3 Date of First Enrollment (India) Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial (India) Publication Details Brief Summary 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 Schizoaffective Disorder (CGI-S-SCA) Change in subject functioning using the Personal and Social Performance Scale (PSP) Change in subject medication satisfaction using the Medication Satisfaction Questionnaire (MSQ) Change in mood symptoms as measured by YMRS (in subjects with YMRS=16 at enrollment) and HAM-D-21) (in subjects with HAM-D-21=16 at enrollment) Total Sample Size=520 Sample Size from India=126 22/10/ /09/2010 Years=3 Months=0 Days=0 Open to Recruitment Completed None This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of paliperidone palmitate, as monotherapy or as an adjunct to mood stabilizers or antidepressants, relative to placebo in delaying the time to relapse in patients with schizoaffective disorder. The study will consist of 4 periods: Screening (up to 7 days), Open-Label page 6 / 7

7 Powered by TCPDF ( Flexible Dose Lead-in (13 weeks), Open-Label Fixed Dose Stabilization (12 weeks), and Double-Blind Relapse Prevention (15 months). Approximately 520 subjects (approximately 126 in India) are to be enrolled in the open-label Lead-in Period in the USA, Bulgaria, Malaysia, Philippines, Romania, Russia, Ukraine, South Africa and India. Of these 520 subjects, it is expected that approximately 286 subjects will qualify to enter the double-blind Relapse Prevention Period. Efficacy will be evaluated during the study using a relapse assessment, the Positive and Negative Symptom Scale (PANSS), the Clinical Global Impression of Severity for Schizoaffective Disorder (CGI-S-SCA), the Personal and Social Performance Scale (PSP), the Young Mania Rating Scale (YMRS), and the Hamilton Rating Scale for Depression (HAM-D). 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), weight, and the monitoring of extrapyramidal symptoms using the Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A). Suicidality will be assessed by the Columbia Suicide Severity Rating Scale (C-SSRS). The tentative date of enrollment of first patient in India is January 25, page 7 / 7