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1 Clinical Trial Details (PDF Generation Date :- Sat, 15 Dec :51:20 GMT) CTRI Number Last Modified On 05/12/2018 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2012/01/ [Registered on: 20/01/2012] - Trial Registered Prospectively No Interventional Drug Randomized, Parallel Group, Placebo Controlled Trial A Long-term study of Lurasidone in eligible subjects from prior Lurasidone study for the treatment of Bipolar I Depression. A Long-Term, Multicenter, Open-Label, Flexible-Dose Continuation Study In Subjects Who Have Completed A Prior Lurasidone Study Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) D , Amendment # 2 dated April 05, 2012 Protocol Number NCT Designation Affiliation ClinicalTrials.gov Details of Principal Investigator Chandrika Arora Director - Quality Assurance Phone Fax Designation Affiliation Quintiles Research Pvt. Ltd. #10, Brigade South Parade 1st Floor, M.G. Road Bangalore KARNATAKA chandrika.arora@quintiles.com Details Contact Person (Scientific Query) Dr Shoibal Mukherjee Vice President, Medical Phone Fax Designation Affiliation Quinitles Research () Private Limited 8th Floor, DLF Square M Block, Jacaranda Marg DLF City Phase II Gurgaon, Haryana Gurgaon HARYANA shoibal.mukherjee@quintiles.com Details Contact Person (Public Query) Suchela Srivatsa Director Clinical Operations Quintiles Research Pvt. Ltd. 301-A-1, Leela Business Park MV Road, Andheri East, Mumbai Gurgaon HARYANA page 1 / 7

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Phone Fax Source of Monetary or Material Support > Sunovion Pharmaceuticals Inc., 1 Bridge Plaza Suite 510, Fort Lee, NJ 07024, United States Type of Sponsor Quintiles Research I Pvt Ltd List of Countries Canada Colombia Czech Republic France Lithuania Romania Russian Federation Slovakia South Africa Ukraine of Principal Investigator Dr Satapathy Ramanand Dr Sandip Shah Dr Ramesh Kumar Mahendru Dr Anil Kumar Tambi Primary Sponsor Details Sunovion Pharmaceuticals Inc 1 Bridge Plaza Suite 510, Fort Lee, NJ 07024, United States Pharmaceutical industry-global B , Shapath IV, Sarkhej-Gandhinagar Road, Ahmedabad , Gujarat of Site Site Phone/Fax/ Brain Mind Behaviour Neurosciences Research Institute Maanav Health Foundation Mahendru Psychiatric Centre Mental Health Care & Research 201, M. V. V. Chambers, Opp. K. G. Hospital, Clock Tower Visakhapatnam ANDHRA PRADESH Brij Psychiatry Clinic & Muskaan Research Centre, Brij Psychiatry Hospital Bhanu Sadan Opp Nimbalkar Chambers, Jambubet, Dandia Bazaar, Vadodara Vadodara 117/40, Sarvodaya Nagar, Kanpur Kanpur Nagar UTTAR PRADESH A-500, First Floor, Govind Marg, Malviya Nagar, Jaipur Jaipur RAJASTHAN drramamnand@yahoo. co.in sandeephshah@hotmai l.com rkmahendru@indiatime s.com dr.tambianil@yahoo.in Dr Mahesh Chudgar Mental Illness 1, Shantinagar Society, page 2 / 7

3 Details of Ethics Committee Dr Dattatreya Madhav Dhavale Dr Rakesh Yadav Dr Mrugesh Vaishnav Dr Hitendra Amritlal Gandhi Dr Buch Bakul Chandrakant Dr Vishal Indla Treatment And Rehabilitation(MITR) Foundation Poona Hospital and Research Centre R.K.Yadav Memorial Mental Health & De-Addiction Hospital Samvedna Psychiatric and Sex therapy Hospitals Sheth Vadilal Sarabhai General Hospital Shri Hatkesh Healthcare Foundation Vijayawada Institute of Mental Health and Neur osciences,(vimhans) Way of Azad Sweet, Ashram Road, Ahmadabad Department of Psychiatry, 27, Sadashiv Peth, Pune Pune MAHARASHTRA B-6, Hanuman Nagar, Main Sirsi Road, Khatipura, Jaipur Jaipur RAJASTHAN , Below Karnavati Hospital, Ellisbridge, Ahmedabad Ahmadabad Department of Psychiatry, Sheth K. M. School of Post Graduate Medicine & Research,Ellisbridge, Ahmadabad Ahmadabad Department of Psychiatry, Opp. Bhutnath Temple, Junagadh Junagadh , V V Rao Street, Suryaraopet, Vijayawada Hyderabad ANDHRA PRADESH mahesh_mitr@yahoo.c o.in dattatreyad@yahoo.co m drrakeshyadav@hotmai l.com drmrugesh@rediffmail.c om hitengandhi@yahoo.co. in bakulbuch@gmail.com vishalindla@gmail.com of Committee Approval Status Date of Approval Is Independent Ethics Committee? Ethical Committee, Sheth VS Hospital, Sheth VS General Hospital, Ellisbridge, Ahmedabad , Gujarat- Dr Hitendra Amritlal Gandhi Approved 12/01/2012 Yes Ethics Committee- MITR Foundation, 1, Shantinagar Society, Way of Azad Sweet, Ashram Road, Ahmedabad-13, Gujarat Approved 03/09/2011 No Ethics Committee, Poona Hospital and Approved 26/08/2011 No page 3 / 7

4 Regulatory Clearance Research Centre, 27, Sadashiv Peth, Pune Ethics Committee, R.K. Yadav Memorial Mental Health and De-addiction Hospital, B-6, Hanuman Nagar, Main Sirsi Road, Khatipura, Jaipur IBIOME Independent Ethics Committee, B-501, Krishna Complex, Opp Devashish School, Nr Rajpath Club, S.G. Highway, Ahmedabad , Gujarat Independent Ethics Committee (IEC), First Floor,M-2, Mahesh Colony, Tonk Phatak, Jaipur Independent Ethics Committee,57, Brahmin Mitra Mandal Society, B/W Paldi Bus Stop & Jalaram Mandir, Paldi, Ahmedabad , Gujarat Approved 20/09/2011 No Approved 04/08/2011 Yes Approved 26/08/2011 Yes Approved 26/08/2011 Yes Institutional Ethics Committee, King George Hospital, Visakhapatnam Approved 22/08/2011 Yes Kanpur Medical Ethics Committee, 117/40, Sarvodaya Nagar, Kanpur Maanav Health Foundation Independent Ethics Committee (MHF IEC), A-1, Anupam Nagar, Behind Rajvee Tower, Near Tube Company, O.P. Road, Vadodara , Gujarat VIMHANS Hospital Ethics Committee, Vijayawada Institute of Mental Health and Neurosciences, , V V Rao Street, Suryaraopet, Vijayawada , A.P. Approved 01/08/2011 No Approved 15/09/2011 No Approved 12/10/2011 No page 4 / 7

5 Status from DCGI Status Date Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Exclusion Criteria Approved/Obtained 26/12/2011 Health Type Patients Patients Condition Bipolar disorder Bipolar disorder, unspecified Type Details Intervention Lurasidone flexibly dosed doses of 20, 40, 60 or 80 mg/day will be taken orally with food. Duration: 18 months Comparator Agent Age From Age To Gender Details There is no comparator as this is A Long-Term, Multicenter, Open-Label, Flexible-Dose Continuation Study In Subjects Who Have Completed A Prior Lurasidone Study Year(s) Year(s) Both Inclusion Criteria There is no comparator as this is A Long-Term, Multicenter, Open-Label, Flexible-Dose Continuation Study In Subjects Who Have Completed A Prior Lurasidone Study The subject or legal guardian provides written informed consent. For eligible subjects under age 18, verbal assent is also required. The subject has completed the extension phase of a prior lurasidone clinical study. Eligible subjects may enroll into this continuation study directly (or within 10 days) after completing the extension phase of a prior lurasidone clinical study. Subjects that have completed an extension study prior to the initiation of this protocol at the study site may participate in this study up to 3 months after completion of the extension phase of the prior lurasidone study. The subject is judged by the Investigator to be suitable for participation in a clinical study involving open-label lurasidone treatment and is able to comply with the protocol. The subject, in the Investigator s judgment, may benefit from continued treatment with lurasidone. Female subject who is of reproductive potential agrees to remain abstinent or use adequate and reliable contraception throughout the study and for at least 30 days after the last dose of lurasidone has been taken. In the Investigator s judgment, the subject will adhere to this requirement. Adequate contraception is defined as continuous use of two barrier methods (eg, condom and spermicide or diaphragm with spermicide) or a hormonal contraceptive. Acceptable hormonal contraceptives include the following: (1) contraceptive implant (such as Norplant) implanted at least 90 days prior to baseline, (2) injectable contraception (such as medroxyprogesterone acetate injection) given at least 14 days prior to baseline, or (3) oral contraceptives taken as directed for at least 30 days prior to baseline. Subjects who are of non-reproductive potential, i.e, subject who is surgically sterile, has undergone tubal ligation, or is postmenopausal (defined as at least 12 months of spontaneous amenorrhea or between 6 and 12 months of spontaneous amenorrhea with follicle stimulating hormone concentrations within postmenopausal range as determined by laboratory analysis) are not required to remain abstinent or use adequate contraception. The subject is in good physical health based on assessment by the Investigator. Rollover subjects should be from only Exclusion Criteria page 5 / 7

6 Details The subject is considered, by the Investigator, to be at imminent risk for homicidal or suicidal behavior The subject requires treatment with any potent cytochrome P4503A4 (CYP3A4) inhibitors or inducers during the study The subject resides in a country where lurasidone has been approved for any indication. The subject is pregnant or nursing (lactating) or is planning pregnancy within the projected duration of the study. The subject answers yes to Suicidal Ideation Items 4 or 5 on the C-SSRS. The subject is currently enrolled in any other investigational study. Method of Generating Random Sequence Method of Concealment Blinding/Masking Not Applicable Centralized Open Label Primary Outcome Outcome Timepoints Safety assessments will include spontaneous 18 months adverse event (AE) and serious adverse events (SAEs) monitoring, clinical laboratory tests (hematology, clinical chemistry, and urinalysis), vital signs, weight, and concomitant medications. Investigators will evaluate the long-term effectiveness of lurasidone by utilizing the Clinical Global Impression-Severity (CGI-S) scale. Investigators will assess the potential for suicidal AEs (suicidal behavior and suicidal ideation) by utilizing the C-SSRS. Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Phase 3 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary This study is not designed to measure efficacy. However, the change from baseline in the CGI-S scores will be used to evaluate the long-term effectiveness of lurasidone treatment. Total Sample Size=600 Sample Size from =60 02/03/ /11/2011 Years=1 Months=6 Days=0 Open to Recruitment Other (Terminated) 18 months This is an open-label continuation study designed to monitor the safety, tolerability and effectiveness of lurasidone in subjects who have completed participation in a lurasidone extension study and who may benefit from continued treatment with lurasidone. Eligible subjects may enroll into this continuation study directly (or within 10 days) after completing the extension phase of a prior lurasidone clinical study. Subjects that have completed an extension study prior to the initiation page 6 / 7

7 Powered by TCPDF ( PDF of Trial of this protocol at the study site may participate in this study up to 3 months after completion of the extension phase of the prior lurasidone study. Eligible subjects will receive treatment in this study for a maximum of 18 months after enrollment. The study will continue until lurasidone is approved and commercially available for any indication in the subject s country, or until the study is terminated by the Sponsor (in a specific country or globally), whichever occurs first. Subjects who meet entry criteria will be treated with lurasidone at doses of 20, 40, 60 or 80 mg/day. The dose of lurasidone may be adjusted between study visits to optimize efficacy and tolerability, as deemed clinically appropriate. Subjects should be instructed to continue the dosing regimen from the previous lurasidone extension study (e.g., in the evening or morning with food). The subject s lurasidone regimen may be changed based on Investigator judgment. At each visit, subjects will be dispensed up to a 3-month supply of study medication, based on Investigator judgment. page 7 / 7