| CTRI Number |
CTRI/2011/08/001963 [Registered on: 24/08/2011] Trial Registered Prospectively |
| Last Modified On: |
04/04/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Efficacy and Safety of Lu AA21004 for Treatment of Major Depressive Disorder |
|
Scientific Title of Study
|
A Multinational, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study to Assess the Efficacy and Safety of Lu AA21004 in Patients With Major Depressive Disorder |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2010-022257-41 |
EudraCT |
| JapicCTI-101344 |
Other |
| LuAA21004/CCT-002 |
Protocol Number |
| NCT01255787 |
ClinicalTrials.gov |
| U1111-1117-6595 |
UTN |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
|
| Phone |
|
| Fax |
|
| Email |
|
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Details of Contact Person
Scientific Query
|
| Name |
Dr Venkataraghuram Muppavarapu |
| Designation |
Senior Clinical Research Physician |
| Affiliation |
Asst Dir Medical Affairs |
| Address |
ICON Clinical Research ( CRO)
Campus 3A - 2nd Floor,RMZ Millenia Business Park,
#143, Dr. M.G.R. Road, Kandanchavady
Chennai
TAMIL NADU
600096
India |
| Phone |
|
| Fax |
|
| Email |
V.Muppavarapu@iconplc.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr John Luke |
| Designation |
Assoc Dir Clin Ops |
| Affiliation |
|
| Address |
ICON Clinical Research India Pvt Ltd.,
Sharadha Towers (unit-II)
No: 56/4, 2nd Floor,
Nandidurg Road,
Bangalore
KARNATAKA
560046
India |
| Phone |
918040394063 |
| Fax |
918041535656 |
| Email |
john.luke@iconplc.com |
|
|
Source of Monetary or Material Support
|
| Takeda Global Research Development Center Asia Pte Ltd |
|
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Primary Sponsor
|
| Name |
Takeda Global Research Development Center Asia Pte Ltd |
| Address |
2 Shenton Way, #15-02 SGX Centre 1, Singapore 068804 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
Croatia
Finland
Germany
India
Japan
Latvia
Malaysia
Montenegro
Philippines
Poland
Republic of Korea
Romania
Russian Federation
Serbia
Ukraine |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr G Prasad Rao |
Asha Hospital, |
298, Road No.14, Banjara Hills, Hyderabad- 500034, Andhra Pradesh, India
Hyderabad
ANDHRA PRADESH |
919440422626
914066759658
prasad40@gmail.com |
| Dr Venugopal Jhanwar |
Deva Mental Health Care, |
B27/70 MN, Durgakunda,Varanasi- 221005, Uttar Pradesh, India.
Varanasi
UTTAR PRADESH |
919935571052
91542-2313748
venugj@gmail.com |
| Dr Ramesh Kumar Mahendru |
Mahendru Psychiatric Center, |
117/40, Sarvodaya Nagar, Kanpur - 208005, Uttar Pradesh, India
Kanpur Nagar
UTTAR PRADESH |
919336124372
915122242034
rkmahendru@indiatimes.com |
| Dr Jitendra Kumar Trivedi |
Manobal Medical Research Centre Pvt. Ltd., |
B-8, Sector A, , Mahanagar, Lucknow- 226006, Uttar Pradesh, India
Lucknow
UTTAR PRADESH |
919415022580
915222260173
jitendra.trivedi@gmail.com |
| Dr Lakshman Dutt |
Seth Vadilal Sarabhai General Hospital, |
Dept of Psychiatry, Ellisbridge, Ahmedabad-380006, Gujarat, India.
Ahmadabad
GUJARAT |
919825046044
917926576652
lakshmandutt1@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| DMHC ETHICS COMMITTEE |
Approved |
| Ethics Committee Asha Hospital |
Approved |
| Ethics Committee, Sheth Vadilal Sarabhai General Hospital. |
Approved |
| Kanpur Medical Ethics Committee. |
Approved |
| Lucknow Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Depressive Disorder, Major , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lu AA21004 10 mg QD |
Lu AA21004 10 mg, tablets, orally, once daily for up to 8 weeks during double blind treatment period. |
| Intervention |
Lu AA21004 20 mg QD |
Lu AA21004 10 mg, tablets, orally, once daily for up to 1 week, followed by Lu AA21004 20 mg, tablets, orally, once daily for up to 7 weeks during double blind treatment period |
| Intervention |
Lu AA21004 5 mg QD |
Lu AA21004 5 mg, tablets, orally, once daily for up to 8 weeks during double blind treatment period. |
| Comparator Agent |
Placebo QD |
Lu AA21004 placebo-matching tablets, orally, once daily for up to 8 weeks during double blind treatment period. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria:
• The subject suffers from Major Depressive Disorder as the primary diagnosis according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria (classification code 296.2x and 296.3x).
• The reported duration of the current major depressive episode is at least 3 months at the Screening Visit.
• The subject has a Montgomery-Asberg Depression Rating Scale (MADRS) total score ≥26 at the Screening and Baseline Visits.
• The subject has a Clinical Global Impression Scale-Severity (CGI-S) score ≥4 at the Screening and Baseline Visits.
|
|
| ExclusionCriteria |
| Details |
Exclusion Criteria:
• The subject has one or more of the following conditions:
o Any current psychiatric disorder other than Major Depressive Disorder as defined in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR; assessed by the Mini International Neuropsychiatric Interview: MINI). A subject who exhibits symptoms of anxiety is eligible unless the subject fulfills the diagnostic criteria for a current anxiety disorder per DSM-IV-TR.
o Current diagnosis or history of manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR.
o Current diagnosis or history of any substance-related disorder (except nicotine and caffeine-related disorders) as defined in the DSM-IV-TR. Subject with confirmed positive urine drug screens will be excluded.
o Presence or history of a clinically significant neurological disorder (including epilepsy).
o Neurodegenerative disorder. (Alzheimers disease, Parkinsons disease, multiple sclerosis, Huntingtons disease, etc.)
o Any DSM-IV-TR axis II disorder that might compromise the study.
• The current depressive symptoms of the subject are considered by the investigator to have been resistant to 2 adequate antidepressant treatments of at least 6 weeks duration each.
• The subject has received electroconvulsive, vagal nerve stimulation, or repetitive transcranial magnetic stimulation therapy within 6 months prior to the Screening Visit.
• The subject is currently receiving formal cognitive or behavioral therapy, systematic psychotherapy, or plans to initiate such therapy during the study.
• The subject is at significant risk of suicide or has a score ≥5 on Item 10 (suicidal thoughts) of the MADRS, or has attempted suicide within 6 months prior to the Screening Visit.
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Method of Generating Random Sequence
|
Stratified randomization |
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Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Change from Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score. |
Baseline and Week 8. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| MADRS response at Week 8, with response defined as a ≥50% decrease in the MADRS total score from Baseline. |
Baseline and Week 8. |
| MADRS remission at Week 8, with remission defined as a MADRS total score ≤10. |
Week 8. |
| Clinical Global Impression Scale - Improvement (CGI-I) score at Week 8. |
Week 8. |
| Change from Baseline in Sheehan Disability Scale (SDS) total score at Week 8. |
Baseline and Week 8. |
|
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Target Sample Size
|
Total Sample Size="615"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
21/12/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
21/03/2011 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
Lu AA21004 was discovered by H. Lundbeck A/S, and is under co-development by H. Lundbeck A/S and Takeda for the treatment of major depressive disorder and general anxiety disorder.
Major depressive disorder (MDD) is a chronic, recurring disease with considerable morbidity in the general population. The estimated lifetime prevalence of major depression in the adult population is 5 to 25%, with a higher prevalence in women (10 to 25%) than in men (5 to 12%). The hallmark of the disease is a depressed mood, with additional symptoms including sleep disturbances, psychomotor agitation or retardation, sexual dysfunction, weight loss, concentration difficulties and delusional ideas. Anxiety symptoms are common; however, the most serious complication of a depressive episode is emergence of suicidal ideation and behavior.
This study will be conducted to assess the efficacy and the safety of three fixed doses of Lu AA21004 in order to establish the appropriate clinical effective dose range. Blood samples will be collected from participants, and a safety follow-up contact (visit or phone call) will be made 4 weeks after completion of the 8-week double-blind treatment period.
Subjects who prematurely discontinue the study during the 8-week double-blind treatment period will be requested to visit the study site for a withdrawal visit as soon as possible and will be contacted for a safety follow-up assessment 4 weeks after withdrawal.
The total duration of the study is 13 weeks in total. |