| CTRI Number |
CTRI/2024/04/066458 [Registered on: 29/04/2024] Trial Registered Prospectively |
| Last Modified On: |
25/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Efficacy and Safety: Vortioxetine vs. Sertraline in Anxiety Disorder Treatment |
|
Scientific Title of Study
|
A comparative study to assess the efficacy and safety of Vortioxetine versus sertraline in patients suffering from Anxiety 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 |
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
Scientific Query
|
| Name |
Mridul Deepanshu |
| Designation |
Post Graduate Resident |
| Affiliation |
IMS & SUM Hospital |
| Address |
IMS & SUM Hospital, Kalinga Nagar K8,
Ghatikia, Bhubaneshwar ORISSA India
Khordha
ORISSA
751003
India |
| Phone |
7903083976 |
| Fax |
|
| Email |
mdeepanshu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kritika Agarwal |
| Designation |
Post Graduate Resident |
| Affiliation |
IMS & SUM Hospital |
| Address |
IMS & SUM Hospital, Kalinga Nagar K8,
Ghatikia, Bhubaneshwar ORISSA India
Khordha
ORISSA
751003
India |
| Phone |
7903559129 |
| Fax |
|
| Email |
kritiag14@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 |
Mitsha Nagpal |
| Address |
IMS & SUM Hospital, Kalinga Nagar K8, Ghatikia, Bhubaneshwar ORISSA India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Riya Shetty |
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 ORISSA India
Khordha
ORISSA
751003
India
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: F411||Generalized anxiety disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Sertraline |
Sertraline (50mg-200mg) will be given and
1. Patients will be assessed by Digit Symbol Substitution Test at baseline, week 4 and week 8.
2. Patients will be assessed using the Trial Taking Test A/B at baseline, 4 weeks and at 8 weeks.
3. Patients will be assessed using the Arizona Sexual Experience Scale at baseline, 4 weeks and at 8 weeks
4. Patients will be assessed using the Stroop Test at baseline, 4 week and 8 weeks.
5. Patients will be assessed using HAM-A, CGI-S and CGI-I at baseline, 4 weeks and 8 weeks.
6. Patients will be assessed using Toronto Side Effects Scale at baseline, week 4 and week 8.
|
| Intervention |
Vortioxetine |
Vortioxetine (10mg-20mg) will be given and
1. Patients will be assessed by Digit Symbol Substitution Test at baseline, week 4 and week 8.
2. Patients will be assessed using the Trial Taking Test A/B at baseline, 4 weeks and at 8 weeks.
3. Patients will be assessed using the Arizona Sexual Experience Scale at baseline, 4 weeks and at 8 weeks
4. Patients will be assessed using the Stroop Test at baseline, 4 week and 8 weeks.
5. Patients will be assessed using HAM-A, CGI-S and CGI-I at baseline, 4 weeks and 8 weeks.
6. 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 anxiety disorder as per ICD-10 diagnostic criteria.
4. HAM-A score ≥18
|
|
| 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.
|
|
|
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 Anxiety Disorder compared to Sertraline. |
At the end of 4 weeks and 8 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Vortioxetine and Sertraline will have similar effects on cognitive functioning. |
At the end of 4 weeks and 8 weeks. |
| Vortioxetine will be safer as compared to Sertraline in sexual functioning. |
At the end of 4 weeks and 8 weeks. |
| Vortioxetine and Sertraline 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
|
Phase 4 |
|
Date of First Enrollment (India)
|
20/05/2024 |
| 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
|
Generalized anxiety disorder (GAD) is prevalent
(12-month and lifetime prevalence of 3.1 and 5.1%, respectively) and associated
with significant impairment in psychosocial functioning, including work
functioning. It is a persistent condition characterized by
chronic anxiety, exaggerated worry and tension, mainly comorbid with Major
Depressive Disorder (MDD).
It includes excessive, uncontrollable and often irrational worry, that
is, apprehensive expectation about events or activities. This excessive worry
often interferes with daily functioning. A condition marked by excessive worry and
feelings of fear, dread, and uneasiness that last six months or longer. Other
symptoms of GAD include being restless, being tired or irritable, muscle
tension, not being able to concentrate or sleep well, shortness of breath, fast
heartbeat, sweating, and dizziness. currently, selective
serotonin reuptake inhibitors and serotonin-norepinephrine reuptake inhibitors
are recommended as first-line treatment of GAD. However, some patients may not
respond to the treatment or discontinue due to adverse effects. Vortioxetine
(VRX) is a multimodal antidepressant with a unique mechanism of action, by
acting as 5-HT3A, 5-HT1D and 5-HT7 receptor
antagonist, partial agonist at the 5-HT1A and 5-HT1B receptors
and inhibitor at the 5-HT transporter. Sertraline is a naphthalenamine derivative with
the predominant pharmacological action of inhibiting presynaptic reuptake of
serotonin from the synaptic cleft. It was initially marketed for the treatment
of major depressive disorder and is now approved for the management of panic
disorder, obsessive-compulsive disorder and post-traumatic stress
disorder. |