| CTRI Number |
CTRI/2024/09/073456 [Registered on: 05/09/2024] Trial Registered Prospectively |
| Last Modified On: |
05/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Campare the effectiveness and safety of Olanzapine tablet and cariprazine tablet in patients of bipolar disorder. |
|
Scientific Title of Study
|
A Comparative study to evaluate the efficacy and safety of Olanzapine and Cariprazine in patients with Bipolar 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 Anil kumar |
| Designation |
Associate Professor |
| Affiliation |
Baba Raghav Das Medical college.Gorakhpur |
| Address |
3rd Floor, Department of Pharmacology, BRD medical College, Gorakhpur.
Gorakhpur
UTTAR PRADESH
273013
India |
| Phone |
8303060884 |
| Fax |
|
| Email |
dranilk194@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anil kumar |
| Designation |
Associate professor |
| Affiliation |
Baba Raghav Das Medical college.Gorakhpur |
| Address |
3rd floor, Department of Pharmacology, BRD medical college, Gorakhpur.
Gorakhpur
UTTAR PRADESH
273013
India |
| Phone |
8303060884 |
| Fax |
|
| Email |
dranilk194@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mukesh Kumar |
| Designation |
Junior Resident |
| Affiliation |
Baba Raghav Das Medical college.Gorakhpur |
| Address |
3rd floor, Department of Pharmacology, Baba Raghav Das Medical college, Gorakhpur
Gorakhpur
UTTAR PRADESH
273013
India |
| Phone |
09808965144 |
| Fax |
|
| Email |
mukesh.raj655@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of pharmacology,Baba Raghav Das Medical college, Gorkhpur, Uttar pradesh, India-273013 |
|
|
Primary Sponsor
|
| Name |
Dr Mukesh kumar |
| Address |
Department of Pharmacology, Baba Raghav Das medical college, Gorakhpur, Uttar Pradesh, India-273013 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mukesh kumar |
Baba Raghav Das Medical College |
Department of Pharmacology, Baba Raghav Das Medical College, Gorkhpur, Uttar Pradesh, India-273013
Gorakhpur
UTTAR PRADESH |
9808965144
mukesh.raj655@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethical Committee BRD medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F319||Bipolar disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cariprazine |
1.5 mg OD for one month |
| Comparator Agent |
Olanzapine |
5 mg OD for one month |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients or attendant giving written informed consent
2 Male and female patients who met diagnostic criteria for bipolar disorder and a major depressive episode as defined by DSM-IV
3 Patients will be required to have been in a depressive episode
|
|
| ExclusionCriteria |
| Details |
1 Patient not willing to participate in the study.
2 Unstable medical illness
3 History of diabetes
4 Recent substance dependence.
5 History of serious psychiatric illness other than bipolar disorder.
•depot antipsychotics or central nervous system medications other than mood stabilisers
•Current rapid-cycling mood disturbance
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quality of life |
Baseline, 2weeks, 4weeks, |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adverse drug reaction of drugs |
Every 2 weeks for 4 weeks. |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
16/09/2024 |
| 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 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
|
To campare the efficacy and safety of Olanzapine 5mg once a day and Cariprazine 1.5mg once a day in patients of Biploar Disorder .These study is the Prospective Randomized Double Blind Parallel group drug study. |