| 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
|
|
|
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.
|
|