| CTRI Number |
CTRI/2024/01/062163 [Registered on: 31/01/2024] Trial Registered Prospectively |
| Last Modified On: |
23/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of Cariprazine drug in Indian patients having Major Depressive Disorder |
|
Scientific Title of Study
|
An investigator initiated, single center, single arm, open-label, cross-
sectional study to assess clinical impact of adjunctive cariprazine in Indian patients
with Major Depressive Disorder. |
| Trial Acronym |
BOOST |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sagar Karia |
| Designation |
Principal Investigator |
| Affiliation |
Care 2 Cure Clinic |
| Address |
Department of Psychiatry, Care 2 cure Clinic, 3, BPS Pratishtha, Opp. BMC T Ward Office,
Mulund (West)
Mumbai
MAHARASHTRA
400080
India |
| Phone |
9594530457 |
| Fax |
|
| Email |
drsagarkaria@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sagar Karia |
| Designation |
Principal Investigator |
| Affiliation |
Care 2 Cure Clinic |
| Address |
Department of Psychiatry, Care 2 cure Clinic, 3, BPS Pratishtha, Opp. BMC T Ward Office,
Mulund (West)
Mumbai
MAHARASHTRA
400080
India |
| Phone |
9594530457 |
| Fax |
|
| Email |
drsagarkaria@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krishnaprasad K MD |
| Designation |
General Manager - Medical Strategic Affairs (India,RoW |
| Affiliation |
Torrent Pharmaceuticals Ltd |
| Address |
Torrent Pharmaceuticals Ltd Ashram Road - Navrangpura
Ahmadabad
GUJARAT
380009
India |
| Phone |
7069000572 |
| Fax |
|
| Email |
krishnaprasadkorukonda@torrentpharma.com |
|
|
Source of Monetary or Material Support
|
| Care 2 Cure Clinic, 3, BPS Pratishtha, Opp. BMC T Ward Office, Mulund (West), Mumbai
– 400080, MAHARASHTRA |
|
|
Primary Sponsor
|
| Name |
Not Applicable |
| Address |
Not Applicable |
| Type of Sponsor |
Other [Not applicable] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sagar Karia |
Care 2 Cure Clinic |
3, BPS Pratishtha, Opp. BMC T Ward Office, Mulund (West), Mumbai – 400080
Mumbai
MAHARASHTRA |
9594530457
drsagarkaria@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICARE ETHICS COMMITTEE |
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 |
| Intervention |
Capsule Cariprazine (1.5 mg, 3 mg, 4.5 mg, 6 mg) |
Capsule Cariprazine has to be administered orally at initial dose of 1.5 mg per day. In patients reporting less than 20% MADRS scores reduction at 2 weeks, Cariprazine dose escalated further, OR in case of less than 50% MADRS score reduction at 4 weeks, Cariprazine dose can be
escalated but not greater than 3 mg per day. Follow-up for 12 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All patients must meet all of the following criteria for enrollment in the study:
1) Clinical cases of Difficult to treat depression showing incomplete response (less than 50% MADRS scores reduction) to SSRI monotherapy receiving Cariprazine
2) Clinical cases receiving Cariprazine with follow-up data for 12 weeks |
|
| ExclusionCriteria |
| Details |
If patient meeting any of the study exclusion criteria should be excluded from study
1) Clinical cases receiving Cariprazine with antecedent history or cause or diagnoses of personality disorder, comorbidities including bipolar disorder, schizophrenia, substance abuse disorder, dementia or other neurodegenerative diseases significantly impacting cognitive functioning, or mood disorders due to an underlying general medical condition
2) Patients currently receiving ECT or Psychotherapy since last six weeks |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in Montgomery–Åsberg Depression Rating Scale (MADRS) total scores
over baseline. |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in functioning using Sheehan Disability Scale (SDS) over baseline |
12 weeks |
| Response rate (Reduction in the MADRS total score of at least 50%) |
End of study period (90 days) |
Remission rate (Clinical cases with MADRS total score less than equal to 10)
|
End of study period (90 days) |
| Clinician Global Assessment for Efficacy Index (CGI-EI) |
End of study period (90 days) |
Adverse event rate
|
Day 14, Day 28, Day 56, Day 90 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
03/02/2024 |
| 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="0"
Months="3"
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
|
This is an investigator initiated, single center, single arm, open-label, cross-sectional, study to assess clinical impact of adjunctive Cariprazine in Indian patients with Major Depressive DisorderKnown cases of MDD will be followed up with initial add-on cariprazine administered as 1.5 or 3 mg once daily as an adjunctive therapy to antidepressant for 12W. The minimum observation period will be of 12W.
Clinical cases of Difficult to treat depression showing incomplete response (<50% MADRS scores reduction) to SSRI monotherapy receiving Cariprazine. Clinical cases receiving Cariprazine with follow-up data for 12 weeks.
|