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CTRI Number  CTRI/2012/03/002480 [Registered on: 06/03/2012] Trial Registered Retrospectively
Last Modified On: 21/02/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A comparative study of the efficacy and safety of Agomelatine 25 mg (or 50 mg) and Paroxetine 20mg (or 30 mg) in patients with major depressive disorder (MDD) 
Scientific Title of Study   A randomized, Multi-center, Double blind, Controlled, comparative study of the efficacy and safety of Agomelatine 25 mg (or 50 mg) and Paroxetine 20mg (or 30 mg) in patients with major depressive disorder (MDD) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CRSC11003, Version 00 Date: 23 March 2011  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mr Manish Yadav 
Designation  Vice President- CRO 
Affiliation  Cadila Pharmaceuticals Limited 
Address  1389, Trasad Road, Dholka

Ahmadabad
GUJARAT
387 810
India 
Phone  912714221481  
Fax  912714220315  
Email  manish.yadav@cadilapharma.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Ashish Akar 
Designation  Manager 
Affiliation  Cadila Pharmaceuticals Limited 
Address  1389, Trasad Road, Dholka

Ahmadabad
GUJARAT
387 810
India 
Phone  912714221481  
Fax  912714220315  
Email  ashish.akar@cadilapharma.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Bhaumik Mody 
Designation  Manager 
Affiliation  Cadila Pharmaceuticals Limited 
Address  1389, Trasad Road, Dholka

Ahmadabad
GUJARAT
387 810
India 
Phone  912714221481  
Fax  912714220315  
Email  bhaumik.mody@cadilapharma.co.in  
 
Source of Monetary or Material Support  
Cadila Pharmaceuticals Limited 
 
Primary Sponsor  
Name  Cadila Pharmaceuticals Limited 
Address  Sarkhej – Dholka Road, Bhat, Ahmedabad – 382 210, (Gujarat – India) Phone : +91-2718-225001 (15 Lines) Fax: +91-2718-225039 
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 = 7  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rajendra Anand  Anand Hospital  Dr Rajendra Anand, Anand Hospital, Near Dena Bank GHA-4,Sector-16,Ghandhinagar.
Ahmadabad
GUJARAT 		 9824017400

drrajendraanand@yahoo.com 
Dr Bhavesh Lakdawala   B. J. Medical College and Civil Hospital  E-1 ward ,Department of Psychiatry B. J. Medical College and Civil Hospital,Ahmedabad-16
Ahmadabad
GUJARAT 		 9687284967

dr_bmlakdawala@yahoo.co.in 
Dr Anukant Mittal  Chatrapati Shivaji Maharaj Hospital Rajiv Gandhi Medical College  Ward No - 16, Department of Psychiatry, Chatrapati Shivaji Maharaj Hospital Rajiv Gandhi Medical college, Old Thane Belapur Road, Kalwa, Dist. Thane - 400 605
Thane
MAHARASHTRA 		 9820164327

akmital@gmail.com 
Dr Bharat Panchal  Civil Hospital & Government Medical college, Bhavnagar  Bhavnagar
Bhavnagar
GUJARAT 		 9427558894

drbnpanchal@rediffmail.com 
Dr Kamlesh Dave  Government Medical College, Surat  Government Medical College, E2/Bungalow No. 7, Professors’ quarters, New Civil Hospital Canpus, Majura Gate, Surat-395001,Gujarat
Surat
GUJARAT 		 9825280320

drkamlesh71@yahoo.co.in 
Dr Mahesh Panchal  Gurukrupa Hospital and Research Center  Psychiatry Division, Gurukrupa Hospital and Research Center, 4-B, Bhuyangdev Society, Bhuyangdev cross road, Ghatlodia, Ahmedabad
Ahmadabad
GUJARAT 		 9426364552

iroclinicaltrials@gmail.com 
Dr Bakul Buch   Santvan Hospital  “Santvan” Hospital, Chittakhana Chowk, Junagadh-362 001(Gujarat-India) (Gujarat-India)
Junagadh
GUJARAT 		 9825220330

bakulbuch@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
Ethique Ethics Committee City: Gandhinagar PI: Dr. Rajendra Anand  Approved 
Global Independent Ethics Committee; City: Ahmedabad, PI: Dr. Mahesh Panchal  Approved 
Human Ethics Committee  Approved 
HUMAN RESEARCH ETHICS COMMITTEE Government Medical college Surat  Approved 
Independent Ethics Committee; City: Ahmedabad; PI: Dr. Bakul Buch  Approved 
THE ETHICS COMMITTEE B J MEDICAL COLLEGE AND CIVIL HOSPITAL AHMEDABAD  Approved 
The Institutional Clinical Ethics Committee Rajiv Gandhi Medical College Thane  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F332||Major depressive disorder, recurrent severe without psychotic features,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Agomelatine tablet  01 tablet of Agomelatine 25 mg for level 01 and 02 tablets of Agomelatine 25 mg for level 2, Cadila Pharmaceuticals Ltd. 
Comparator Agent  Paroxetine Tablets  01 tablet of Paroxetine 20 mg for level 1 and Paroxetine 20 mg + Paroxetine 10 mg for level 2, Intas Pharmaceticals Limited 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Human male and/ or female Patients within 18 to 65 years of age (inclusive) leaving in India.
2. Adult patients of Major Depressive Disorder (MDD). [Diagnosis of Major Depressive Disorder, single or recurrent episode, according to DSM-IV criteria, HAM-D total score should be more than or equal to 20]
3. CGI-S greater than or equal to 4
4. Hospital Anxiety Depression Scale" HAD depression sub-score greater than or equal to 11
5. Sheehan disability scale: SDS auto-completed
6. Not having any significant diseases or clinically significant abnormal findings except Major Depressive Disorder (MDD) during screening, medical history, physical examination, laboratory evaluations, 12-lead ECG and X-ray chest (postero-anterior view) recordings.
7. The investigator must ensure that the respective hepatic, renal, haematopoietic, cardiac and respiratory functions are appropriate to include the patient in the study. If the respective lab values are outside the reference range, the investigator must document in the patient’s file and CRF that he/she foresees no related risk if the patient will be treated within the trial.
8. Able to comply with study procedures in the opinion of the investigator.
9. Patients must demonstrate adequate decisional capacity to make a choice about participating in this research study and must provide informed consent to participate.
10. In case of female patients:
They must have been surgically sterile at least for 6 months prior to participation in trial (documentation of sterilization must be provided);
OR
Those who are of child bearing potential must be using a suitable and effective double contraceptive method during the study. Results of the pregnancy test done at screening must be negative and available prior to dosing.
Women of childbearing potential (WOCP) must have a negative  Hcg test at screening. WOCP must abstain from sexual activity that could result in pregnancy, or use acceptable contraceptives throughout the period of study drug exposure and for 30 days after the last dose of study drug. Acceptable contraceptives include IUDs and double barrier methods (such as condom or diaphragm with spermicidal gel).
WOCP should not participate in artificial insemination procedures and must agree not to become pregnant during the period of study drug exposure, and for 30 days after the last dose of study drug. WOCP who are not currently sexually active, must agree to use acceptable contraception, as defined above, if they decide to become sexually active during the period of study drug exposure and must agree not to become pregnant for 30 days after the last dose of study drug. Women not of childbearing potential are defined as those who have been surgically sterilized (at least 6 months prior to screening) or who have been postmenopausal for at least 12 consecutive months. (Investigator will be responsible for determining whether the patient is using appropriate birth control measures for study participation) 
 
ExclusionCriteria 
Details  1. History of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, eating disorder, or obsessive compulsive disorder.
2. Any current Axis I disorder other than major depressive disorder which is the focus of treatment.
3. Current violent behaviour.
4. History of syncope, or orthostatic hypotension
5. Positive testing for the drugs of abuse (amphetamines, opioids, cocaine, methadone, marijuana or any cannabinoids, barbiturates, phencyclidine) done by urine scan at Screening.
6. Substance or alcohol dependence within 3 months before randomization.
7. The presence of clinically significant abnormal laboratory values during screening.
8. A positive hepatitis screen including hepatitis B surface antigen, HCV antibodies.
9. A positive test result for HIV antibody.
10. Sitting blood pressure less than 110/70 mm Hg or pulse rate less than 60 or more than 100 beats per minute at screening.
11. Any condition/ Abnormal baseline findings that in the investigator’s judgement might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to obtain the objective of the study.
12. Psychosis judged to be the direct physiological effect of an abused medication or substance.
13. Patients with a known intolerance or lack of response to previous treatment with the molecule closely related Agomelatine. (e.g. fluoxetine)
14. Patients with substance abuse or dependence, as defined by DSM-IV, and not in full remission.
15. History or known case of Organic Brain Disease.
16. Patients with the abnormal cardiac conditions
17. History of seizure disorder (except febrile convulsions)
18. Patients having Hypertension or on anti hypertensive medications
19. Patients with Diabetes mellitus
20. Dementia related psychosis
21. Pregnant (refer inclusion criteria no 10) or lactating females
22. Electroconvulsive therapy (ECT) within 30 days prior to randomization
23. Patients known to be non-responders to Paroxetine or Agomelatine treatment or resistant to Paroxetine or Agomelatine for the current episode.
24. Patient under behavioral or Pharmacological treatment of depression or stabilized by an antidepressant for the current episode.
25. Patient treated with Transcranial Magnetic Stimulation (TMS) within the last three months before selection.
26. Hypo or hyprethyroidism except if the treatment has been stabilized for at least 3 months.
27. Known hypersensitivity to Agomelatine or Paroxetine or any of the excipients. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Improvement in HAMD scores from baseline to end of 6 weeks therapy  Improvement in HAMD scores from baseline to end of 6 weeks therapy 
 
Secondary Outcome  
Outcome  TimePoints 
• Clinical Global Impression- Severity (CGIS): Screening
• Clinical Global Impression- Change (CGIC) : End of Study
• Hamilton Anxiety Rating Scale
• Hospital Anxiety and Depression Scale
• Sheehan Disability Scale
• Leeds Sleep Evaluation Questionnaire • Any deviation from the routine health status (clinical or laboratory) 		 screening, end of study 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   30/01/2012 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   A randomized, Multi-center, Double blind, Controlled,  Comparative study of the efficacy and safety of Agomelatine 25 mg (or 50 mg)  and Paroxetine 20mg (or 30mg) in patients with major depressive disorder (MDD).
Agomelatine is a melatonergic agonist (MT1 and MT2 receptors) and serotonergic antagonist (5-HT2C). In humans, Agomelatine has positive phase shifting properties; it induces a phase advance of sleep, body temperature decline and melatonin onset.
 
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