CTRI Number |
CTRI/2014/03/004453 [Registered on: 06/03/2014] Trial Registered Retrospectively |
Last Modified On: |
04/03/2014 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
comparison of cost between two drugs in treatment of depression |
Scientific Title of Study
|
A randomized study of the cost effectiveness and tolerability of escitalopram and desvenlafaxine in treatment of moderate to severe depression |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Moulya Nagraj |
Designation |
Post Graduate |
Affiliation |
Kempegowda Institute of Medical Sciences |
Address |
Kempegowda Institue of Medical Sciences,Department of Pharmacology, Banashankari 2nd stage.
Bangalore KARNATAKA 560070 India |
Phone |
8095481875 |
Fax |
|
Email |
moulyanagraj@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
DrGirish K |
Designation |
Professor |
Affiliation |
Kempegowda Institute of Medical Sciences |
Address |
Kempegowda Institue of Medical Sciences,Department of Pharmacology, Banashankari 2nd stage
Bangalore KARNATAKA 560070 India |
Phone |
8095481875 |
Fax |
|
Email |
drgirish_k@rediffmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Moulya Nagraj |
Designation |
Post Graduate |
Affiliation |
Kempegowda Institute of Medical Sciences |
Address |
Kempegowda Institue of Medical Sciences, Department of Pharmacology,Banashankari 2nd stage
Bangalore KARNATAKA 560070 India |
Phone |
8095481875 |
Fax |
|
Email |
moulyanagraj@gmail.com |
|
Source of Monetary or Material Support
|
Kempegowda Institute of Medical Sciences. |
|
Primary Sponsor
|
Name |
Moulya Nagraj |
Address |
Department of Pharmacology,KIMS, Bangalore |
Type of Sponsor |
Other [self] |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Lakshmi Pandit |
Kempegowda Institute of Medical Sciences |
KIMS,Department of Psychiatry,Banashankari,2nd stage,Bangalore-560070 Bangalore KARNATAKA |
8095481875
lvp4562@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
KIMS-IEC |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
moderate depression, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
desvenlafaxine |
Desvenlafaxine 50mg -100mg /day for 8 weeks ,it is a SNRI used in treatment of depression. |
Comparator Agent |
Escitalopram |
Escitalopram 10mg -20mg/day for 8weeks,it is a SSRI used in the management of depression. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
• Subjects of either gender aged between 18-65 years.
• Subjects with first episode or recurrent episode of depression according to (ICD-10) with baseline score >18 and < 40 according to MADRS.
• Willingness to give written informed consent and available for follow up.
|
|
ExclusionCriteria |
Details |
• Atypical depression
• Postpartum depression
• Pregnant women, breast feeding and women planning to conceive.
• Subjects with severe depression requiring ECT and with high risk of suicidal tendency.
• Co-morbid psychiatric illnesses
• Previous history of epilepsy and sexual dysfunction
• Serious or uncontrolled medical illness like glaucoma, hypertension, diabetes mellitus, hyperlipidemia, myocardial infarction, hepatic and renal impairment.
• Depression secondary to medical illnesses, post traumatic depression.
• Known history of allergy to both the study medications.
• Participation in any other research study in recent past
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Case Record Numbers |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
reduction of MADRS score to 12 or by 50% from baseline scores and QoL is measured using 12-item short form of the Medical Outcomes Study questionnaire (SF-12) |
baseline, 4week, 8 week, follow up |
|
Secondary Outcome
|
Outcome |
TimePoints |
Remission of scores by 50% |
baseline,4 week, 8 week, follow up. |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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
|
Post Marketing Surveillance |
Date of First Enrollment (India)
|
01/01/2013 |
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="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
none yet
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Depression is the most common mood disorder affecting the population of all age groups with considerable impact on the quality of life with increased morbidity and mortality, imposing a great burden on the individual, family and society. The increasing prevalence of depression is of global concern regarding the cost of health care, loss of earning thus raising the interest in cost-benefit analysis in treating depression with the available therapies. Even though depression can be treated by non-pharmacological methods like psychotherapy, electroconvulsive therapy and phototherapy, pharmacological approach remains the mainstay of the treatment. Currently, several classes of effective antidepressants are available such as tricyclic antidepressants (TCAs), selective serotonin reuptake inhibitors (SSRIs), serotonin-noradrenaline reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs) and atypical antidepressants. SSRIs are the generally preferred drugs as primary option because of their high efficacy, safety and tolerability. Escitalopram (S-enantiomer of citalopram) is one of the most widely prescribed SSRI because of its good tolerability and minimal drug interactive potential. Desvenlafaxine, an SNRI, is one of the most effective antidepressant, particularly for resistant depression, and also claimed to have additional therapeutic advantages. Both the drugs are known to have similar efficacy and few studies have been done in the Indian population to compare the cost-effectiveness and tolerability of these two drugs, hence the present study is taken up. Objectives of the Study To evaluate the cost-effectiveness of escitalopram and desvenlafaxine in treatment of moderate to severe depression. To assess the tolerability and QoL of escitalopram and desvenlafaxine in the study subjects |