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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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

 
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