CTRI

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CTRI Number

CTRI/2024/10/076064 [Registered on: 29/10/2024] Trial Registered Prospectively

Last Modified On:

27/10/2024

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Cariprazine as an add on agent in depression patients.

Scientific Title of Study

Study of Efficacy and Safety of Cariprazine Augmentation in Major 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	Dr Shreya Agrawal
Designation	Junior Resident
Affiliation	Jawaharlal Nehru Medical College, Aligarh Muslim University
Address	Department of Psychiatry Jawaharlal Nehru Medical College, AMU Campus, Medical Road, Aligarh Aligarh UTTAR PRADESH 202001 India
Phone	7037027782
Fax
Email	shreyaagrawal2@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Mohammed Reyazuddin
Designation	Associate Professor
Affiliation	Jawaharlal Nehru Medical College
Address	Department of Psychiatry Jawaharlal Nehru Medical College, AMU Campus, Medical Road, Aligarh Aligarh UTTAR PRADESH 202001 India
Phone	9997258800
Fax
Email	psychjnmc92@gmail.com

Details of Contact Person
Public Query

Name	Dr Mohammed Reyazuddin
Designation	Associate Professor
Affiliation	Jawaharlal Nehru Medical College
Address	Department of Psychiatry Jawaharlal Nehru Medical College, AMU Campus, Medical Road, Aligarh Aligarh UTTAR PRADESH 202001 India
Phone	9997258800
Fax
Email	psychjnmc92@gmail.com

Source of Monetary or Material Support

Jawaharlal Nehru Medical College, Aligarh Muslim University,Medical college road, AMU Campus, Aligarh-202002, UP,INDIA

Primary Sponsor

Name	Dr Shreya Agrawal
Address	Department of Psychiatry, Jawaharlal Nehru Medical College, AMU Campus, Medical Road, Aligarh 202002, India
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 Shreya Agrawal	Jawaharlal Nehru Medical College and Hospital	Department of Psychiatry, Jawaharlal Nehru Medical College, Amu Campus,Medical Road, Aligarh 202002, Aligarh, Uttar Pradesh Aligarh UTTAR PRADESH	7037027782 shreyaagrawal2@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee (Regd.) Jawaharlal Nehru medical College and Hospital, Faculty of Medicine, Aligarh muslim University, Aligarh ,UP, India-202002	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,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Cariprazine 1.5mg	Sixty patients will be randomly divided into two groups A and B: Group A will receive 1.5mg Of caripraine Evaluations will be done at end of 2, 4 and 6 weeks.
Intervention	Cariprazine 3.0mg	Sixty patients will be randomly divided into two groups A and B:Group B will receive 3.0mg of Cariprazine. Evaluations will be done at end of 2, 4 and 6 weeks

Inclusion Criteria

Age From	18.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	1. DSM 5 criteria for Major depressive disorder. 2. Able to give consent. 3. MADRS score more than 20 despite adequate trial of one antidepressant. 4. patients on stable dose of same antidepressant for past 2 weeks.

ExclusionCriteria

Details

1. Patients who have bipolar depression, depression with psychotic features.
2. Any other comorbid psychiatric or medical diagnosis.
3. Not able to give consent.
4. Taking any other medications except benzodiazepine.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Case Record Numbers

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
The severity of Depressive disorder which will be measured by percentage MADRS, HAMD score change from baseline and at the end of 6 weeks.	6 months

Secondary Outcome

Outcome	TimePoints
Response or remission rate will be calculated at each time point (2, 4 and 6 weeks) using MADRS and HAMD score.	6 months

Target Sample Size

Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0"

Phase of Trial

Phase 3/ Phase 4

Date of First Enrollment (India)

15/11/2024

Date of Study Completion (India)

Date Missing

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="0"
Months="6"
Days="0"

Recruitment Status of Trial (Global)

Not Yet Recruiting

Recruitment Status of Trial (India)

Completed

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

This study aims to study the efficacy , safety and tolerability of Cariprazine as an adjunctive treatment in Major Depressive Disorder. Secondary objectives include comparing effects as well as adverse drug reactions of Cariprazine with different antidepressants. Conducted over 6 months at Jawaharlal Nehru Medical College, AMU, Aligarh, UP, this prospective, parallel arm , cross sectional study will include adult patients diagnosed with Major Depressive Disorder as per DSM-5 criteria. Participants will undergo comprehensive clinical history assessments and baseline evaluation using MADRS, HAMD scales. Sixty patients will be randomised into two groups : Group A will receive Cariprazine 1.5 mg and Group B will receive Cariprazine 3.0mg. Evaluation will be done at the end of 2, 4 and 6 weeks.