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CTRI Number  CTRI/2018/09/015861 [Registered on: 27/09/2018] Trial Registered Prospectively
Last Modified On: 08/07/2019
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   This study is to understand the Clinical Characters, Social & demographic Profile, and Treatment Patterns in Patients with Bipolar Depression in India 
Scientific Title of Study   Multicenter, Noninterventional, Cross-sectional Study to Evaluate the Clinical Characteristics, Sociodemographic Profile, and Treatment Patterns in Patients with Bipolar Disorder in India 
Trial Acronym  BPD study 
Secondary IDs if Any  
Secondary ID  Identifier 
EPIDI062  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr M S Reddy 
Designation  Principal Investigator 
Affiliation  Asha Hospital 
Address  ASHA HOSPITAL, ROADNO.14, BANJARA HILLS, HYDERABAD

Hyderabad
ANDHRA PRADESH
500034
India 
Phone  040-66752222  
Fax    
Email  drmsreddy@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr M S Reddy 
Designation  Principal Investigator 
Affiliation  Asha Hospital 
Address  ASHA HOSPITAL, ROADNO.14, BANJARA HILLS, HYDERABAD


ANDHRA PRADESH
500034
India 
Phone  040-66752222  
Fax    
Email  drmsreddy@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sneha Nair 
Designation  Head- Clinical Operations 
Affiliation  Abbott Healthcare Pvt Ltd 
Address  Floor 16, Godrej BKC, Plot No. C – 68, BKC, Near MCA Club, Bandra (E) Mumbai – 400 051 Mumbai MAHARASHTRA

Mumbai
MAHARASHTRA
400051
India 
Phone  02238160910  
Fax    
Email  sneha.nair@abbott.com  
 
Source of Monetary or Material Support  
Abbott Healthcare Pvt Ltd 16th Floor, Godrej BKC Plot C – 68, “G” Block Bandra Kurla Complex Near MCA Club, Bandra (East) Mumbai 400 051 India  
 
Primary Sponsor  
Name  Abbott Healthcare Pvt Ltd 
Address  Floor 16, Godrej BKC, Plot No. C – 68, BKC, Near MCA Club, Bandra (E) Mumbai – 400 051 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 35  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rashmin Achalia  Achaliya NeuroPsychiatry Hospital  Opp. VITS Hotel, Railway Station Road, Aurnagabad - 431001
Aurangabad
MAHARASHTRA 		 9028851672

rashminachalia@gmail.com 
Dr M S Reddy  Asha Hospital  Dr M S Reddys Consulting room, 1st floor, ASHA HOSPITA, ROADNO.14 ,BANJARA HILLS, HYDERABAD
Hyderabad
ANDHRA PRADESH 		 04066752222

drmsreddy@gmail.com 
Dr Prasad Rao  Asha Hospital  Dr. Prasad Raos consulting room, 1st floor, ASHA HOSPITA, ROAD NO.14 ,BANJARA HILLS, HYDERABAD
Hyderabad
ANDHRA PRADESH 		 04023542838

prasad40@gmail.com 
Dr Prashant Shukla  Asha Neuropsychiatric clinic  Asha Neuropsychiatric clinic, Mahanagar Lucknow
Lucknow
UTTAR PRADESH 		 9919111135

DOCPSHUKLA@GMAIL.COM 
Dr Sanjay Garg  Care And Cure Polyclinic  P 239 A, Block A, Laketown, Kolkata Pin 700089
Kolkata
WEST BENGAL 		 9748924848

sgarg243@yahoo.co.in 
DR PHANI PRASANT  CHETANA HOSPITAL  2-3-578/1 Kachi Colony,, Minister Road, Besides KIMS Hospital, Secunderabad, Telangana 500003
Hyderabad
TELANGANA 		 9849807740

drphani@gmail.com 
Dr Vijay Seshadri  CHETANA HOSPITAL  2-3-578/1 Kachi Colony,, Minister Road, Besides KIMS Hospital, Secunderabad, Telangana 500003
Hyderabad
TELANGANA 		 9849542546

drvijayseshadri@gmail.com 
Dr Rajiv Antani  Dr Antanis Clinic  17, B G Trade Ctr, Panchbatti, Bharuch-392001
Bharuch
GUJARAT 		 9825097470

rajivantani28@yahoo.com 
Dr Chetan Hansaliya  Dr Hansaliyas Clinic  Dr Hansaliyas Clinic, 2, 80 Feet Road, Patel Nagar, Patel Nagar, Rajkot, Gujarat 360002
Rajkot
GUJARAT 		 9825217810

chetanansalia@yahoo.com 
Dr Mahendra Singh   Dr Mahendra Singh clinic  Dr Mahendra Singh clinic, Gaushala Chauraha Kidwai Nagar Kanpur, UP
Kanpur Nagar
UTTAR PRADESH 		 9415475360

i.mahendra.singh.dr@gmail.com 
Dr Vimal Somaiya  Dr Vimal Somaiyas Clinic  Dr Vimal Somaiyas Clinic, 2nd Floor, Om Planet, Opp. Nirmala Convent, Nirmala Convent Main Rd, Saurashtra Kala Kendra, Rajkot, Gujarat 360001
Rajkot
GUJARAT 		 9879156425

vimal.somaiya@gmail.com 
Dr Abhinav Pandey   Dr. Abhinav Pande Clinic  Dr. Abhinav Pande Clinic, Sec-14 House no-899, Indira Nagar Lucknow, UP
Lucknow
UTTAR PRADESH 		 9936588999

dr.abhinavpandey@gmail.com 
Dr Abhiruchi Chatterjee  Dr. Abhiruchi Chatterjees Clinic  Dr. Abhiruchi Chatterjees Clinic, 37, South End Park, Kolkata - 700029
Kolkata
WEST BENGAL 		 9830172728

abhiruchichatterjee@gmail.com 
Dr Amrut Bodani  Dr. Amrut Bodani Clinic  A-19, Krishna Chambers, Anuradha medical lane Opp ST Workshop, Naroda Patia, Ahmedabad-382345
Ahmadabad
GUJARAT 		 9825488790

bodani@mail.com 
Dr Arghya Dutta  Dr. Arghya Dutta Clinic  Dr. Arghya Duttas Clinic, 62/A/1, Lal Bahadur Shastri Road: P.O. - Konnagar Dist.- Hooghly Pin - 712235
Hugli
WEST BENGAL 		 9674749295

dr.arghya.dutta@gmail.com 
Dr Hansal Bachech   Dr. Hansal Bachech Clinic  Santvan, 211, Sheetal Plaza,, Nr Rambag BRTS bus stop,, Maninagar, Ahmedabad, Gujarat 380028
Ahmadabad
GUJARAT 		 9825920555

myhappyminds@gmail.com 
Dr M L Aggrawal  Dr. M L Aggrawals Clinic  Dr. M L Aggrawals Clinic, A-11, JAWAHAR NAGAR, KOTA (RAJ).
Kota
RAJASTHAN 		 9829035071

drmlagrawal@gmail.com 
Dr Parthsarathi Nandi  Dr. Parthsarathi Nandis Clinic  Dr. Parthsarathi Nandis Clinic, P-535,Raja Basanta Roy Road,Kolkata 700029
Kolkata
WEST BENGAL 		 9831106270

dr.p.s.nandi@gmail.com 
Dr Pratanu Saha  Dr. Pratanu Sahas Clinic  Nandapally, B-Block, P.O. & P.S. Naihati, Dist. North 24 Paraganas, W.B, PIN - 743165
Kolkata
WEST BENGAL 		 9433730959

spratanu@gmail.com 
Dr Shantanu Bharti   Dr. Shantanu Bharti clinic  Dr Shantanu Bhartis clinic, 1/42 N,Vineet Khand, Gomti Nagar, Lucknow 226010
Lucknow
UTTAR PRADESH 		 9412832687

shantanubharti@gmail.com 
Dr Shashwat Saxena  Dr. Shashwat Saxena clinic  Dr. Shashwat Saxena clinic, LGF Singhal complex, Sitapur Road, Daliganj Railway Crossing, Lucknow, UP 226020
Lucknow
UTTAR PRADESH 		 9935979501

shashwat6284@gmail.com 
Dr Soumitra Basu  Dr. Soumitra Basus Clinic  P-273, Block - A, Ground Floor, Bangur Avenue, Kolkata -700055
Kolkata
WEST BENGAL 		 9433060156

drsbasu2115@gmail.com 
Dr Faisal Ahmed Khilji   HAPPY FAMILY HOSPITAL  HAPPY FAMILY HOSPITAL, PLOT NO 5, Sector N6, E-9, near Kulswamini mangal karyalay, Azad Chowk, Aurangabad, MH, 431003
Aurangabad
MAHARASHTRA 		 8237160548

faisalkhilji@gmail.com 
Dr Rajesh Vaghasia  Manas Hospital  Manas Hospital, 4th Floor, Om Complex, Ramkrishna Nagar, Main Road, Raiya Circle, Opp to Punjab National Bank, Virani Chowk, Rajkot- 360007, Gujarat
Rajkot
GUJARAT 		 0281-2461936

rajesh.vaghasia@ymail.com 
Dr Ninad Baste  Mansa Clinic   Flat No. 6, Raviraj Apt., Above Parihar Dep Store, DP Road, Opp Tennis court, Parihar Chowk, Aundh, Pune - 411007
Pune
MAHARASHTRA 		 9881875915

ninad.baste@gmail.com 
Dr Debashish Konar  Mental Health Care Center  Mental Health Care Center, Puspak, 129/1 Bakul Bagan Road, Bhawanipur, Kolkata- 700025
Kolkata
WEST BENGAL 		 9434009113

devkon59@yahoo.com 
Dr Rohan Jahagirdar  MJM HOSPITAL  1194/23 JANARDHAN SADAN, GHOLE ROAD, PUNE 411001
Pune
MAHARASHTRA 		 9372416491

drjahagirdarrohan@gmail.com 
Dr A Q Jilani  National Hospital and Neuro Centre  Near Madiyaon Over Bridge, Khadri, Sitapur road, Lucknow- 226021
Lucknow
UTTAR PRADESH 		 9044817161

imjilani@gmail.com 
Dr Sadeq Qureshi  Prerana Hospital  Prerana Hospital, Near 7 Hills Bridge, Aurangabad 431001
Aurangabad
MAHARASHTRA 		 9923790591

q.sadiq12@gmail.com 
Dr Manik Bhise   PRERNA HOSPITAL  MARATHWADA ENGINEERING BUILDING, NEAR HOTEL YASHODEEP, JALNA ROAD, AURANGABAD 431003
Aurangabad
MAHARASHTRA 		 9823703068

dr.manik.bhise@gmail.com 
Dr Suresh Kumar  PSYMED HOSPITAL  PSYMED HOSPITAL, D.NO.49/2, HARRINGTON ROAD, CHETPUT, CHENNAI - 600030. TAMILNADU
Chennai
TAMIL NADU 		 9840031559

msuresh1955@gmail.com 
Dr Ravi Kumar   REGENCY HOSPITAL  REGENCY HOSPITAL, 3,sargodha colony ,rajneet nager kanpur
Kanpur Nagar
UTTAR PRADESH 		 9839104901

ravi_regency@rediffmail.com 
Dr Debashish Ray   The Medstar Clinics  39 Shakespeare Sarani, Near Kala Mandir, Kolkata - 700017
Kolkata
WEST BENGAL 		 9830048567

mindhealth@gmail.com 
Dr K B Patel  Vaidik De Addiction And Rehab Centre  Vaidik De Addiction And Rehab Centre, Mandotri, Patan, Patan-Gujarat - 384265, 
Patan
GUJARAT 		 9825493040

bhartikamlesh@yahoo.com 
Dr Tushar Agravat  Vansh Psychiatric Hospital  Vansh Psychiatric Hospital, Sector 1A, Gandhidham, Gujarat 370201
Kachchh
GUJARAT 		 9978838854

tushar.agravat@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 8  
Name of Committee  Approval Status 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F319||Bipolar disorder, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Male and female patients aged between 18 and 65 years
2. Patients who are able to read and write
3. Patients diagnosed with BPD type I or II per DSM-5 criteria, with a duration of at least 2 years
4. Patients and family care giver/legally acceptable representative (LAR) who are willing and competent to sign and date a patient authorization form (PAF) for participation in the study 
 
ExclusionCriteria 
Details  1. Patients with a diagnosis of any schizophrenia spectrum disorder after the diagnosis of BPD
2. Patients with mental disorders of organic origin.
3. Patients with any condition that in the opinion of the investigator makes the patient unsuitable for inclusion based on clinical judgment. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Description of detailed illness pattern of BPD
2. Description of detailed pharmacological treatments
 		 1 
 
Secondary Outcome  
Outcome  TimePoints 
1. Description of sociodemographic and clinical factors associated with BPD
2. Functional impairment as assessed by WHO DAS 2.0, 12-Item version
3. Compliance to treatment regimen
4. Quality of life as assessed by brief QoL-BD
5. Caregiver burden as assessed by the BSFC 		 1 
 
Target Sample Size   Total Sample Size="600"
Sample Size from India="600" 
Final Enrollment numbers achieved (Total)= "574"
Final Enrollment numbers achieved (India)="574" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/11/2018 
Date of Study Completion (India) 13/05/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not yet published 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   This is a Multicenter, Noninterventional, Cross-sectional Study to understand the Clinical Characteristics, Sociodemographic Profile, and Treatment Patterns in Patients with Bipolar Disorder in India. This study neither involve drug nor it involves any intervention.  
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