CTRI

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CTRI Number

CTRI/2025/11/098208 [Registered on: 28/11/2025] Trial Registered Prospectively

Last Modified On:

26/11/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Comparison of Vortioxetine and Paroxetine in treating depression in women undergoing menopause or after menopause.

Scientific Title of Study

Comparative effectiveness of Vortioxetine and Paroxetine in peri menopausal and post menopausal depression

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr RITU
Designation	POST GRADUATE JUNIOR RESIDENT
Affiliation	GOVERNMENT MEDICAL COLLEGE AND HOSPITAL, SECTOR 32, CHANDIGARH
Address	DEPARTMENT OF PSYCHIATRY, LEVEL 5, D BLOCK, GOVERNMENT MEDICAL COLLEGE AND HOSPITAL, SECTOR 32, CHANDIGARH Chandigarh CHANDIGARH 160030 India Chandigarh CHANDIGARH 160030 India
Phone	7743071909
Fax
Email	mamgainritu23@gmail.com

Details of Contact Person
Scientific Query

Name	Dr PRITI ARUN
Designation	PROFESSOR
Affiliation	GOVERNMENT MEDICAL COLLEGE AND HOSPITAL, SECTOR 32, CHANDIGARH
Address	DEPARTMENT OF PSYCHIATRY, LEVEL 5, D BLOCK, GOVERNMENT MEDICAL COLLEGE AND HOSPITAL, SECTOR 32, CHANDIGARH Chandigarh CHANDIGARH 160030 India Chandigarh CHANDIGARH 160030 India
Phone	9646121612
Fax
Email	drpritiarun@gmail.com

Details of Contact Person
Public Query

Name	Dr RITU
Designation	POST GRADUATE JUNIOR RESIDENT
Affiliation	GOVERNMENT MEDICAL COLLEGE AND HOSPITAL, SECTOR 32, CHANDIGARH
Address	DEPARTMENT OF PSYCHIATRY, LEVEL 5, D BLOCK, GOVERNMENT MEDICAL COLLEGE AND HOSPITAL, SECTOR 32, CHANDIGARH Chandigarh CHANDIGARH 160030 India Chandigarh CHANDIGARH 160030 India
Phone	7743071909
Fax
Email	mamgainritu23@gmail.com

Source of Monetary or Material Support

Department of Psychiatry Level 5, D block government medical college and hospital sector 32 chandigarh

Primary Sponsor

Name	Governement Medical College and Hospital
Address	Sector 32, Chandigarh
Type of Sponsor	Government medical college

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 2
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Ritu	Government Medical College and hospital , chandigarh	Room no 4212, Level 4, D block,Government Medical College and Hospital, Sector 32 , Chandigarh Chandigarh CHANDIGARH Chandigarh CHANDIGARH	7743071909 mamgainritu23@gmail.com
Dr Ritu	Government Medical College and hospital , chandigarh	Room no 1123, Level 2 , D block , Government Medical College and Hospital, Sector 32 , Chandigarh Chandigarh CHANDIGARH Chandigarh CHANDIGARH	7743071909 mamgainritu23@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional ethics committee (GMCH Chandigarh)	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type

Condition

Patients

(1) ICD-10 Condition: F322||Major depressive disorder, singleepisode, severe without psychotic features, (2) ICD-10 Condition: F320||Major depressive disorder, singleepisode, mild, (3) ICD-10 Condition: F321||Major depressive disorder, singleepisode, moderate, (4) ICD-10 Condition: F324||Major depressive disorder, singleepisode, in partial remission, (5) ICD-10 Condition: F325||Major depressive disorder, singleepisode, in full remission, (6) ICD-10 Condition: F328||Other depressive episodes, (7) ICD-10 Condition: F329||Major depressive disorder, singleepisode, unspecified, (8) ICD-10 Condition: F330||Major depressive disorder, recurrent, mild, (9) ICD-10 Condition: F331||Major depressive disorder, recurrent, moderate, (10) ICD-10 Condition: F332||Major depressive disorder, recurrent severe without psychotic features, (11) ICD-10 Condition: F334||Major depressive disorder, recurrent, in remission, (12) ICD-10 Condition: F338||Other recurrent depressive disorders, (13) ICD-10 Condition: F339||Major depressive disorder, recurrent, unspecified, (14) ICD-10 Condition: F39||Unspecified mood [affective] disorder,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Paroxetine	Following baseline assessments, Paroxetine will be initiated at a dose of 12.5 mg per day. Dose optimization will be guided by changes observed on the HDRS 17 scale. After two weeks of treatment, if the HDRS 17 score shows a reduction of 25 percent or more from baseline, the current dose will be maintained. If the HDRS 17 score shows less than 25 percent reduction, the dose of Paroxetine will be increased to 25 mg per day.At the four week follow up, if the HDRS 17 score has reduced by more than 50 percent , the dose will remain unchanged . If the reduction is less than 50 percent , the dose of Paroxetine will be further increased to 37.5 mg per day . Once the optimal dose is reached, patients will be maintained on that dose for the next six weeks.Final assessment will be conducted at 10 weeks.
Intervention	Vortioxetine	Following baseline assessments, Vortioxetine will be initiated at a dose of 10 mg per day. Dose optimization will be guided by changes observed on the HDRS 17 scale. If Vortioxetine 10 mg per day is not well tolerated, the dose will be reduced to 5 mg per day. After two weeks of treatment, if the HDRS 17 score shows a reduction of 25 percent or more from baseline, the current dose will be maintained. If the HDRS 17 score shows less than 25 percent reduction, the dose of Vortioxetine will be increased to 15 mg per day. At the four week follow up, if the HDRS 17 score has reduced by more than 50 percent, the dose will remain unchanged. If the reduction is less than 50 percent ,the dose of Vortioxetine will be further increased to 20 mg per day.Once the optimal dose is reached, patients will be maintained on that dose for the next six weeks. Final assessment will be conducted at 10 weeks.

Inclusion Criteria

Age From	45.00 Year(s)
Age To	65.00 Year(s)
Gender	Female
Details	Peri menopausal and post menopausal female with diagnosis of depressive disorders as per ICD 11

ExclusionCriteria

Details

1.Co-morbid psychiatric conditions such as Schizophrenia, Bipolar Disorder, Obsessive-Compulsive Disorder (OCD), severe depression with psychotic feature, comorbid substance dependence, excluding nicotine and caffeine or exhibiting active suicidal ideation or behaviour.
2.Chronic neurological illnesses or unstable medical conditions.
3.Intellectual Disability.
4.Those who have undergone Cognitive Behavioural Therapy, Cognitive Enhancement Therapy, or electroconvulsive therapy (ECT) within the last three months.
5. Pregnant or breastfeeding women or received hormonal replacement therapy (HRT) within 3 months prior to study enrolment.
6. Known allergy or hypersensitivity reaction to study drugs.
7.Premature menopause (before age of 40 year

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Not Applicable

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
To assess and compare the clinical effectiveness of Vortioxetine and Paroxetine in treatment of perimenopausal and postmenopausal depression	Baseline,2 weeks, 4 weeks, 6 weeks,10 weeks

Secondary Outcome

Outcome	TimePoints
•To assess & compare the effectiveness of Vortioxetine & Paroxetine on vasomotor & cognitive symptoms in perimenopausal & postmenopausal women with depression. •To evaluate tolerability & side effect profile of Vortioxetine & Paroxetine in this demographic. •To assess & compare the effectiveness of Vortioxetine & Paroxetine on quality of life.	Baseline, 2 weeks, 4 weeks, 6 weeks, 10 weeks

Target Sample Size

Total Sample Size="66"
Sample Size from India="66"
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

N/A

Date of First Enrollment (India)

10/12/2025

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)

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

After obtaining ethical and CTRI approval, 66 women diagnosed with depressive disorders as per ICD 11 and identified as perimenopausal or postmenopausal will be recruited from the Psychiatry and Obstetrics and Gynaecology outpatient departments of GMCH 32 Chandigarh. Participants meeting inclusion criteria and providing written informed consent will be randomly assigned to two groups using a computer generated random number table: Group A Vortioxetine and Group B Paroxetine. Baseline assessments will include sociodemographic and clinical profiles, depression (HDRS 17), anxiety (HAM A), quality of life (WHOQOL BREF Hindi), menopausal symptoms (Menopause Rating Scale), and cognitive functioning (MoCA Hindi, DSST, TMT, Digit Span Test), along with physical and laboratory evaluations.Vortioxetine will be initiated at 10 mg per day adjustable 5 to 20 mg per day and Paroxetine at 12.5 mg per day adjustable 12.5 to 37.5 mg per day based on response on HDRS 17. Patients will be followed up at 2, 4, 6, and 10 weeks to assess clinical improvement, cognitive function, and side effects. Final evaluations, including laboratory and neurocognitive assessments, will be conducted at 10 weeks. A reduction of 50 percent or more in HDRS 17 score from baseline will define treatment response. Participants developing intolerable side effects, becoming UPT positive, or withdrawing consent will be dropped and managed as per protocol.