| CTRI Number |
CTRI/2011/08/001946 [Registered on: 10/08/2011] Trial Registered Retrospectively |
| Last Modified On: |
09/08/2011 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effects of Agomelatine oral tablets in patients with Major Depressive Disorder |
|
Scientific Title of Study
|
"A Multicentric, Open-label, Randomized, Comparative, Parallel-group, Active-Controlled Phase III Clinical Trial of the Efficacy and Safety of Agomelatine oral tablets in patients with Major Depressive Disorder |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Precise/Agomelatine/012010A |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Devendra Save |
| Designation |
Consultant Psychiatrist |
| Affiliation |
|
| Address |
Karuna Hospital, Borivali, Mumbai
Mumbai
MAHARASHTRA
400092
India |
| Phone |
|
| Fax |
|
| Email |
devendra.save@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Devendra Save |
| Designation |
Consultant Psychiatrist |
| Affiliation |
|
| Address |
Karuna Hospital, Borivali, Mumbai
MAHARASHTRA
400092
India |
| Phone |
|
| Fax |
|
| Email |
devendra.save@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Devendra Save |
| Designation |
Consultant Psychiatrist |
| Affiliation |
|
| Address |
Karuna Hospital, Borivali, Mumbai
MAHARASHTRA
400092
India |
| Phone |
|
| Fax |
|
| Email |
devendra.save@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Precise Chemipharma Pvt. Ltd., 108, Malwa, Patanwala Ind. estate, Ghatkopar west, Mumbai |
|
|
Primary Sponsor
|
| Name |
Precise Chemipharma Pvt Ltd |
| Address |
108, Malwa, Patanwala Ind. estate, Ghatkopar west, Mumbai |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Devendra Save |
Karuna Hospital |
Karuna Hospital, Borivali, Mumbai
Mumbai
MAHARASHTRA |
02228953009
devandra.save@yahoo.in |
| Dr Mahesh Desai |
Mahesh Desais clinic |
307-308, Narmada Apartment, Behind Valuable Auto garage, Nr. Kadivala School, Surat-2
Surat
GUJARAT |
02612477677
drmahesh54@yahoo.in |
| Dr S Dhadiwal |
Manoshanti Nursing Home |
Manoshanti Nursing Home, 1st Floor, Umiya Apartment, Canada Corner, Nashik
Nashik
MAHARASHTRA |
579319
mind@bom6.vsnl.net.in |
| Dr PM Chougule |
Swastik Hospital |
Swastik Hospital, 43A/12, Plot no. 6E, Behind Nashte Estate, Near Mahavir Garden, Kolhapur
Kolhapur
MAHARASHTRA |
2658835
drpmchougule@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| COMSARTs, Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Major Depressive Disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Agomelatine |
one tablet once daily at bed time for 8 weeks |
| Comparator Agent |
Placebo |
one tablet once daily at bed time for 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All subjects with duly filled and signed in ICFs [Informed Consent Forms].
Adult males or females, age 18-65 years (inclusive).
Diagnosis of Major Depressive Disorder, single or recurrent episode, according to DSM-IV criteria.
HAM-D17 total score less than or 22 at Screening and Baseline.
CGI-Severity score less than or 4 at Screening and Baseline.
Only patients who complete the core protocol are eligible to participate in the Open-Label Extension Phase. |
|
| ExclusionCriteria |
| Details |
Patients with seasonal patterns, psychotic features or post-partum onset. Patients with other types of depression or psychiatric conditions (including bipolar I and II or dysthymic disorders) and those who displayed marked suicidal intent or known suicidal tendencies.
Patients undergoing electroconvulsive treatment, insight-oriented or structured psychotherapy during the 3 months prior to assessment. Patients undergoing light therapy during the 2 weeks before assessment.
Patients who are otherwise eligible but who had not derived clinical benefit from two adequate antidepressant trials for the current episode, or from a previous trial of Agomelatine, will also be excluded.
History of schizophrenia, schizoaffective disorder, eating disorder, or obsessive compulsive disorder.
Any current Axis I disorder other than major depressive disorder which is the focus of treatment.
Substance or alcohol abuse in the last 30 days, dependence in the last 6 months.
Concomitant psychotropic medication, including herbal preparations and melatonin.
Psychotherapy of any type.
Female patients of childbearing potential who are not using effective contraception. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary efficacy parameter is the evaluation of MDD symptom score in the second week and at the end of the trial. |
second week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the proportion of patients who demonstrate clinical improvement at Week 8, where improvement is defined by a score of 1 or 2 on the CGI-I scale [Time Frame: 8 weeks ] |
8 weeks |
| To evaluate the proportion of patients who achieve remission at Week 8, where remission is defined by a total score of more than or 7 on the HAM-D17 [Time Frame: 8 week] |
8 weeks |
| To evaluate efficacy with respect to the proportion of patients who demonstrate clinical response, where response is defined by a reduction of at least 50% in the baseline HAM-D17 at week 8 [Time Frame: 8 weeks] |
8 weeks |
| To evaluate the change from baseline to week 8 on the subscale scores (Maier, anxiety, retardation and sleep) of the clinician-rated HAM-D17 [Time Frame: 8 weeks] to evaluate subjective sleep (onset and quality), as measured by the scores on the Leeds Sleep Evaluation Questionnaire (LSEQ) at week 8 [Time Frame: 8 weeks] |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/01/2011 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is A Multicentric, Open-label, Randomized, Comparative, Parallel-group, Active-Controlled Phase III Clinical Trial of the Efficacy and Safety of Agomelatine oral tablets in patients with Major Depressive Disorder that will be conducted in four centres in India |