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CTRI Number  CTRI/2024/06/068969 [Registered on: 14/06/2024] Trial Registered Prospectively
Last Modified On: 21/05/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   "Evaluating the Efficacy and Safety of Vortioxetine vs. Escitalopram in Treating Depressive Disorder: A Comparative Study" 
Scientific Title of Study   A comparative study to assess the efficacy and safety of Vortioxetine versus Escitalopram in patients suffering from Depressive Disorder. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jitendriya Biswal 
Designation  Associate Professor 
Affiliation  IMS & SUM Hospital 
Address  Department of Psychiatry, IMS & SUM Hospital, Kalinga Nagar K8, Ghatikia, Bhubaneshwar ORISSA India Khordha

Khordha
ORISSA
751003
India 
Phone  9337270395  
Fax    
Email  drjbiswal@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Jitendriya Biswal 
Designation  Associate Professor 
Affiliation  IMS & SUM Hospital 
Address  Department of Psychiatry, IMS & SUM Hospital, Kalinga Nagar K8, Ghatikia, Bhubaneshwar ORISSA India Khordha


ORISSA
751003
India 
Phone  9337270395  
Fax    
Email  drjbiswal@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Mridul Deepanshu 
Designation  Post Graduate Resident 
Affiliation  IMS & SUM Hospital 
Address  Department of Psychiatry, IMS & SUM Hospital, Kalinga Nagar K8, Ghatikia, Bhubaneshwar ORISSA India Khordha

Khordha
ORISSA
751003
India 
Phone  7903083976  
Fax    
Email  mdeepanshu@gmail.com  
 
Source of Monetary or Material Support  
Department of Psychiatry, IMS & SUM Hospital, Kalinga Nagar K8/14 , Mouza Ghatikia, Bhubaneshwar ORISSA India Department of Psychiatry, IMS & SUM Hospital, Kalinga Nagar K8/14 , Mouza Ghatikia, Bhubaneshwar ORISSA India Khordha ORISSA 751003 India 
 
Primary Sponsor  
Name  Himshikha Srivastava 
Address  Department of Psychiatry, IMS & SUM Hospital, Kalinga Nagar K8, Ghatikia, Bhubaneshwar ORISSA India 751019 
Type of Sponsor  Other [Secondary Investigator] 
 
Details of Secondary Sponsor  
Name  Address 
Alok Gupta  Department of Psychiatry, IMS & SUM Hospital, Kalinga Nagar K8, Ghatikia, Bhubaneshwar ORISSA India 
Bijay Kumar Prusty  Department of Psychiatry, IMS & SUM Hospital, Kalinga Nagar K8, Ghatikia, Bhubaneshwar ORISSA India 
Kritika Agarwal  Department of Psychiatry, IMS & SUM Hospital, Kalinga Nagar K8, Ghatikia, Bhubaneshwar ORISSA India 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jitendriya Biswal  Department of Psychiatry, IMS & SUM Hospital  Kalinga Nagar K8/14 , Mouza Ghatikia, Bhubaneshwar ORISSA India Department of Psychiatry, IMS & SUM Hospital, Kalinga Nagar K8/14 , Mouza Ghatikia, Bhubaneshwar
Khordha
ORISSA 
9337270395

drjbiswal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee IMS and SUM Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F321||Major depressive disorder, singleepisode, moderate,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Escitalopram (10mg-20mg) Oral  1. Patients will be assessed by DSST (executive function, speed of processing, attention), Trail Making Test A/B (TMT-A: speed of processing; TMT-B: executive function), Stroop test (congruent and incongruent: executive function) at baseline, week 4 and week 8. 2. Patients will be assessed using the Arizona Sexual Experiences Scale (ASEX) at baseline, 4 weeks and at 8 weeks. 3. Patients will be assessed using HAM-D, CGI-S and CGI-I at baseline, 4 weeks and 8 weeks. 4. Patients will be assessed using Toronto Side Effects Scale at baseline, week 4 and week 8.  
Intervention  Vortioxetine (10mg-20mg) Oral  1. Patients will be assessed by DSST (executive function, speed of processing, attention), Trail Making Test A/B (TMT-A: speed of processing; TMT-B: executive function), Stroop test (congruent and incongruent: executive function) at baseline, week 4 and week 8. 2. Patients will be assessed using the Arizona Sexual Experiences Scale (ASEX) at baseline, 4 weeks and at 8 weeks. 3. Patients will be assessed using HAM-D, CGI-S and CGI-I at baseline, 4 weeks and 8 weeks. 4. Patients will be assessed using Toronto Side Effects Scale at baseline, week 4 and week 8.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Both male and female patients aged between 18 and 60 years.
2. Those giving written consent/guardians giving written consent (in cases where the patients were too ill to understand the process of informed consent and give an informed choice.)
3. People diagnosed with the depressive disorder as per ICD-11 diagnostic criteria.

 
 
ExclusionCriteria 
Details  1. Systemic or Neurological Disorder affecting Cognition, Behavior or Mental Status.
2. Substance dependence except for Nicotine and Caffeine within the past month of entering the study.
3. Long-standing medical or surgical illnesses.
4. Patients with mental retardation or organic brain disorders.
5. Patients suffering from neurological, metabolic and vascular conditions affecting sexual function.
6. Patients with sexual dysfunction at baseline were excluded from the study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Vortioxetine will be more efficacious on symptom
severity in patients suffering from Depression compared to Escitalopram. 
At the end of 4 weeks and 8 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
Vortioxetine and Escitalopram will have similar
effects on cognitive functioning. 
At the end of 4 weeks and 8 weeks. 
Vortioxetine will be safer as compared to
Escitalopram in sexual functioning. 
At the end of 4 weeks and 8 weeks. 
Vortioxetine and Escitalopram will have similar side
effects. 
At the end of 4 weeks and 8 weeks. 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   20/06/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Major depressive disorder (MDD) is a common mental disorder often associated with deficits in cognitive function. The Diagnostic and Statistical Manual 5 (DSM-5) lists impairment in cognition (i.e. diminished ability to think or concentrate or indecisiveness) as a criterion item in the diagnosis of a major depressive episode (MDE).

Major depressive disorder (MDD) and generalized anxiety disorder (GAD) are each associated with high rates of sexual dysfunction. One long-term study, for example, estimated that sexual dysfunction was nearly twice as common in people with MDD as in the general population. Pharmacotherapy for MDD or GAD can alleviate sexual dysfunction in some patients, but treatment with most antidepressants is itself associated with some form of sexual dysfunction or worsening sexual dysfunction. As many as 30%–80% of patients treated with selective serotonin reuptake inhibitors (SSRIs) experience some form of treatment-emergent sexual dysfunction (TESD), which can affect any aspect of sexual activity, including desire, arousal, and orgasm. Sexual dysfunction associated with antidepressant use reduces self-esteem and quality of life and burdens interpersonal relationships. It is particularly bothersome to patients and may affect treatment compliance. Escitalopram is a frontline antidepressant. Few studies have examined cognitive and sexual functioning after being treated with antidepressants involving vortioxetine.

We expect vortioxetine to perform better than escitalopram in cognitive and sexual functioning and at least as well as Escitalopram in treating symptoms of depression.

 
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