| CTRI Number |
CTRI/2022/01/039860 [Registered on: 31/01/2022] Trial Registered Prospectively |
| Last Modified On: |
06/09/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Other (Specify) [A Multicenter, Prospective, Post Marketing Surveillance study ] |
| Study Design |
Other |
|
Public Title of Study
|
Post marketing surveillance of Aripiprazole tablet |
|
Scientific Title of Study
|
A Multicenter, Prospective, Post Marketing Surveillance study of
Aripiprazole tablet in Adolescent patients with Schizophrenia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CT/ARIP/SCH/21/PMS_01 version 2.0 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrRam Gupta |
| Designation |
Assistant General Manager |
| Affiliation |
Torrent Research Centre |
| Address |
Clinical Research Department, Old building, second floor,Torrent Pharmaceuticals Limited Research Centre, Village Bhat, Dist. Gandhinagar - 382 428 Gujarat, India.
Clinical Research Department, Old building, second floor,Torrent Pharmaceuticals Limited Research Centre, Village Bhat, Dist. Gandhinagar - 382 428 Gujarat, India
Gandhinagar
GUJARAT
382428
India |
| Phone |
07923969100197 |
| Fax |
07923969135 |
| Email |
ramgupta@torrentpharma.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Binita Shah |
| Designation |
Assistant Manager |
| Affiliation |
Torrent Research Centre |
| Address |
Clinical Research Department, Old building, second floor,Torrent Pharmaceuticals Limited Research Centre, Village Bhat, Dist. Gandhinagar - 382 428 Gujarat, India.
Clinical Research Department, Old building, second floor,Torrent Pharmaceuticals Limited Research Centre, Village Bhat, Dist. Gandhinagar - 382 428 Gujarat, India.
Gandhinagar
GUJARAT
382428
India |
| Phone |
07923969100164 |
| Fax |
07923969135 |
| Email |
binitashah@torrentpharma.com |
|
Details of Contact Person
Public Query
|
| Name |
DrRam Gupta |
| Designation |
Assistant General Manager |
| Affiliation |
Torrent Research Centre |
| Address |
Clinical Research Department, Old building, second floor,Torrent Pharmaceuticals Limited Research Centre, Village Bhat, Dist. Gandhinagar - 382 428 Gujarat, India.
Clinical Research Department, Old building, second floor,Torrent Pharmaceuticals Limited Research Centre, Village Bhat, Dist. Gandhinagar - 382 428 Gujarat, India.
Gandhinagar
GUJARAT
382428
India |
| Phone |
07923969100197 |
| Fax |
07923969135 |
| Email |
ramgupta@torrentpharma.com |
|
|
Source of Monetary or Material Support
|
| Torrent Pharmaceuticals Limited
Research Centre,Village Bhat, Dist Gandhinagar 382428 Gujarat India |
|
|
Primary Sponsor
|
| Name |
Torrent Pharmaceuticals Limited |
| Address |
Research Centre,Village Bhat, Dist Gandhinagar 382428 Gujarat India |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajendra Anand |
Anand Multispeciality Hospital |
4th Floor, Sarthak Mall Mahatma Mandir Road, Cross Road, Sargasan, Gandhinagar, Gujarat 382421, INDIA
Gandhinagar
GUJARAT |
9824017400
drrajendraanand@yahoo.com |
| Dr T S Sathyanarayana Rao |
Dr. T S Sathyanarayana Rao |
Mahatma Gandhi Road, Fort Mohalla, Mysuru, Karnataka 570004
Mysore
KARNATAKA |
9845282399
contact@jsshospital.in |
| Dr Dhananjay Chaudhari |
GVSM Medical College |
Swaroop Nagar, Kanpur-208002, UP, India
Kanpur Dehat
UTTAR PRADESH |
9336049009
aradhana.research@gmail.com |
| Dr Niket Kasar |
KEM Hospital |
489, Sardar Moodliar Road, Rasta Peth, Pune 41101, India
Pune
MAHARASHTRA |
9823783083
niketkasar2010@gmail.com |
| Dr Tarak Shah |
Mental Illness Treatment Rehabilitation Foundation (MITR) |
1 Shanlinagar Society, way to CCD Gully, Ashram Road, Usmanpura, Ahmedabad - 3 80013, Gujarat, India
Ahmadabad
GUJARAT |
9824096430
Tarak_mitr@yahoo.co.in |
| Dr Shri Gopal Goyal |
S.P. Medical College & A.G. of Hospitals |
Room No.21, First Floor, Department of Psychiatry, S.P. Medical College & A.G. of Hospitals. Bikaner 334 001, Rajasthan, India
Bikaner
RAJASTHAN |
8947825749
shrigopalgoyal@gmail.com |
| Dr Bakul Buch |
Shri Hatkesh Healthcare Foundation |
Shri Hatkesh Healthcare Foundation
College Road, Near Bhuthnath Temple, Junagadh, Gujarat 362001, India
Junagadh
GUJARAT |
9825220330
bakulbuch@gmail.com |
| Dr Ramanshanker Yadav |
Shubham Multi Speciality Hospital Ahmedabad Gujarat |
120 Feet Ring Rd, Near Sardar Patel Circle, Sardar Patel Colony, Sundar Nagar, Navjivan, Ahmedabad, Gujarat 380013
Ahmadabad
GUJARAT |
8264049261
07927683535
yadavramashanker@gmail.com |
| Dr Suresh Kumar Kota |
Sravani Mental Health Care & De-addiction Centre |
Sambasiva Peta 1st Ln, Railpet, Guntur, Andhra Pradesh 522001
Guntur
ANDHRA PRADESH |
9848303169
drkotasuresh@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| Anand Ethics Committee Anand Multispecialty Hospital and Research Centre |
Approved |
| ETHICS COMMITTEE GSVM MEDICAL COLLEGE KANPUR GSVM MEDICAL COLLEGE KANPUR |
Approved |
| ETHICS COMMITTEE, S.P.MEDICAL COLLEGE, BIKANER rajasthan |
Submittted/Under Review |
| Hatkesh Healthcare Foundation Ethics Committee Hatkesh Healthcare Foundation Junagadh Gujarat |
Approved |
| IEC ADITYA MULTI SPECIALITY HOSPITAL , ADITYA MULTI SPECIALITY HOSPITAL guntur Andhra pradesh |
Approved |
| Institutional Ethics Committee JSS Medical College Mysore Karnataka |
Submittted/Under Review |
| KEM Hospital Research Centre Ethics Committee Pune Maharashtra |
Approved |
| Sangini Hospital Ethics Committee Ahmedabad Gujarat |
Submittted/Under Review |
| Shubham Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F209||Schizophrenia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Patients shall receive designated daily dose of aripiprazole tablet (2 mg to 30 mg) once in a
day throughout the study i.e. 6 weeks |
Aripiprazole tablet As per the prescribing information, the initial dose
of tablet will be 2 mg, which will be titrated to 5 mg after 2 days and 10 mg after 2 additional
days When appropriate, subsequent dose will be increased in 5 mg increments without exceeding the maximum daily dose of 30 mg. Aripiprazole is effective in a dose range of 10
to 30 mg/day. |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female adolescent patients aged 13 to 17 years (both inclusive)
2. Patients diagnosed with schizophrenia according to the International Classification of Diseases (ICD) and who as per investigator discretion need aripiprazole therapy |
|
| ExclusionCriteria |
| Details |
1. Patients with known hypersensitivity to aripiprazole.
2. Patients with concurrent psychiatric comorbidity requiring pharmacotherapy and/or
medications.
3. Any evidence of suicide risk; or a history or current diagnosis of schizoaffective disorder,
mental retardation, major depressive episodes, neuroleptic malignant syndrome, any
neurologic disorder other than Tourettes syndrome, severe head trauma, or any unstable
medical condition
4. Pregnant or lactating and sexually active adolescent boys or adolescent girls who do not
agree to abstinence or birth control
5. In the opinion of the investigator patient is either unable to cooperate or unlikely to
adhere with any study procedures |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Safety endpoints:
1. Frequency and severity of adverse events.
2. Clinical laboratory assessments (haematology and biochemistry)
3. Vital signs and Physical Examination |
Visit 1, Day 1
Visit 2, Week 6 ± 4 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
15/02/2022 |
| 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="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aripiprazole Tablets (2 mg, 5 mg, 10 mg, 15 mg, 20 mg, 30 mg) are approved and available in Indian market for the treatment of schizophrenia in adolescents. Safety and tolerability of aripiprazole are well established in various clinical trials. The current study has been planned to collect safety and tolerability data of aripiprazole tablet in the adolescents population in India.This study will be an open label, multi-centric, prospective, single arm study. The study includes enrolment visit (Day 1), followed by telephonic safety assessment (week 1, 2, 3, 4), and end of study visit (week 6). Patients will be screened for the eligibility. The screening procedure will be conducted after obtaining Assent from patients and Informed consent form from parents respectively. Adolescent patients with schizophrenia who fulfill the eligibility criteria will be enrolled in the study as per the investigator’s discretion. Patients shall receive designated daily dose of Aripiprazole tablet (2 mg to 30 mg) once in a day throughout the study i.e. 6 weeks. The dose and time of administration of aripiprazole will be based on investigator’s discretion. As per the prescribing information, the initial dose of tablet will be 2 mg, which will be titrated to 5 mg after 2 days and 10 mg after 2 additional days. When appropriate, subsequent dose will be increased in 5 mg increments without exceeding the maximum daily dose of 30 mg. Aripiprazole is effective in a dose range of 10 to 30 mg/day. After up titrating the dose, if a patient is not able to tolerate the given study medication dose, will be down titrated as per the investigator’s discretion. Safety evaluation will be performed every week telephonically for the first 4 weeks and at the end of the study. Each participant shall be required to visit the study sites for: • Visit 1: Enrolment visit (Day 1) • Telephonic safety assessment : (Week 1 ± 3days) • Telephonic safety assessment : (Week 2 ± 3days) • Telephonic safety assessment : (Week 3 ± 3days) • Telephonic safety assessment : (Week 4 ± 3days) • Visit 2 : End of study visit (Week 6 ± 4 days) The study will be carried out according to the protocol approved by the institutional ethical committee (IEC) of the participating site/institution. The study will be conducted in accordance with the “Declaration of Helsinki†and “ICH-Good clinical practice†guidelines and pertinent regulatory requirements |