| CTRI Number |
CTRI/2024/04/065780 [Registered on: 16/04/2024] Trial Registered Prospectively |
| Last Modified On: |
15/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
An interventional study to see outcome by comparing efficiency and safety of two drugs i.e. of levetiracetam versus oxcarbazepine in management of bipolar disorder. |
|
Scientific Title of Study
|
A randomized, open label trial to compare efficacy and safety of levetiracetam versus oxcarbazepine in management of 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 Vishesh Kumar |
| Designation |
Postgraduate- Junior Resident |
| Affiliation |
Uttar Pradesh University of Medical Sciences (UPUMS) |
| Address |
Department of Pharmacology, Uttar Pradesh University of Medical sciences, Safai, Etawah
Vivekanand PG hostel, UPUMS campus, UPUMS, Safai, Etawah 206130
Etawah
UTTAR PRADESH
206130
India |
| Phone |
9599719530 |
| Fax |
|
| Email |
russiavish@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr C.V. Singh |
| Designation |
Professor |
| Affiliation |
UTTAR PRADESH UNIVERSITY OF MEDICAL SCIENCES (UPUMS) |
| Address |
Department of Pharmacology, academic Block, Uttar Pradesh University of Medical Sciences, Safai
Doctor Block, UPUMS campus, Saifai
Etawah
UTTAR PRADESH
206130
India |
| Phone |
9927791470 |
| Fax |
|
| Email |
cvsingh.singh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vishesh Kumar |
| Designation |
Postgraduate- Junior Resident |
| Affiliation |
Uttar Pradesh University of Medical Sciences (UPUMS) |
| Address |
Department of Pharmacology, academic Block, Uttar Pradesh University of Medical Sciences, Safai
Vivekanand PG hostel, UPUMS campus, Safai
Etawah
UTTAR PRADESH
206130
India |
| Phone |
9599719530 |
| Fax |
|
| Email |
russiavish@gmail.com |
|
|
Source of Monetary or Material Support
|
| Uttar Pradesh University of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Uttar Pradesh University of Medical sciences Department of Pharmacology and Psychiatry |
| Address |
Medical college Building, Department of Pharmacology, UPUMS, Safai, Etawah-206130 |
| Type of Sponsor |
Government medical college |
|
|
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 Vishesh Kumar |
Uttar Pradesh University of Medical Sciences (UPUMS) |
Department of Pharmacology, academic Block, Uttar Pradesh University of Medical Sciences, Safai
Etawah
UTTAR PRADESH |
9599719530
russiavish@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, UTTARPRADESH UNIVERSITY OF MEDICAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F316||Bipolar disorder, current episodemixed, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Levetiracetam |
Tablet Levetiracetam 500/750/1000 mg twice daily for indication for management of bipolar disorder for 12 weeks. |
| Comparator Agent |
Oxcarbazepine |
tablet oxcarbazepine 300/900/1200 mg twice daily for indication for management of bipolar disorder for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
Meet ICD -10 criteria.
No previous history of psychiatry illness
|
|
| ExclusionCriteria |
| Details |
Any Pregnant or nursing mother
Unstable or uncontrolled cardiovascular disease Evidence of recent ischemic event
Hypertension or metabolic disorder
Any history of seizure disorder or ischemic stroke
Any malignancy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
reduction in mood episodes as well as the time recurrence of mood episodes
the study may find the one drug to be superior or equivalent to the other in terms of efficacy |
baseline
3rd week
6th week
9th week
12th week
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcome measures could include the improvement in quality of life such as functioning or cognitive performance It is expected that both drugs will improve these outcome |
baseline
3rd week
6th week
9th week
12th week |
|
|
Target Sample Size
|
Total Sample Size="98"
Sample Size from India="98"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
26/04/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
The purpose of the present study is to evaluate the efficacy and safety of the
Levetiracetam and Oxcarbazepine for the management of newly diagnosed bipolar disorder
patients in Indian rural tertiary care center and further to determine which is more promising
among both drugs. Newly diagnosed patient for bipolar disorder will be randomized for the test
drugs i.e., Levetiracetam & Oxcarbazepine. Patient will be randomly assigned in 1:1 ratio to each
group and each group will consist of minimum 50 patients. Group 1 will receive Levetiracetam
and group 2 will receive Oxcarbazepine on 1st day and will be followed up every 3 weeks until 12
weeks. The primary endpoint is response defined for burden of illness via Patient Global
Impression of Change Scale i.e., mild change: 1-3, moderate change: 3-5 & severe change: 5-7.
The study will also include as Hamilton Depression Rating Scale (HDRS) in depressive phase with
a score assessment: 0-7 = normal, 8-13= mild depression, 14-18= moderate depression, & more
than 23 = very severe depression. And lastly using Young Mania Rating Scale (YMRS). The
secondary endpoint will be in response defined using statistical analysis via ANOVA, Student’s
t- Test and CHI SQUARE for qualitative and quantitative assessment. |