| CTRI Number |
CTRI/2018/10/016232 [Registered on: 31/10/2018] Trial Registered Prospectively |
| Last Modified On: |
30/10/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Relationship between valproate levels in blood and its therapeutic effects in patients with Mania |
|
Scientific Title of Study
|
Serum valproate concentrations and therapeutic outcome in patients with bipolar disorder: An observational study in a tertiary care setting. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vishnu Eriyat |
| Designation |
Junior Resident |
| Affiliation |
JIPMER Pondicherry |
| Address |
Department of Pharmacology
Institute block 3rd floor
JIPMER
pondicherry 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9037823770 |
| Fax |
|
| Email |
eriyatvishnu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Manikandan |
| Designation |
Associate Professor |
| Affiliation |
JIPMER Pondicherry |
| Address |
Associate Professor
Department of Pharmacology
Institute block 3rd floor
JIPMER Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9443774648 |
| Fax |
|
| Email |
drsmanikandan001@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ravi Philip RajKumar |
| Designation |
Additional Professor and Head |
| Affiliation |
JIPMER Pondicherry |
| Address |
Additional Professor and Head
Department of Psychiatry
JIPMER Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9884713673 |
| Fax |
|
| Email |
ravi.psych@gmail.com |
|
|
Source of Monetary or Material Support
|
| JIPMER Intramural fund
JIPMER Campus
Dhanvantri nagar
Pondicherry 605006 |
|
|
Primary Sponsor
|
| Name |
JIPMER Intramural fund |
| Address |
JIPMER Campus
Pondicherry
605006 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Vishnu Eriyat |
JIPMER Pondicherry |
Department of psychiatry
Inpatient ward
Ground floor(Institute Block)
JIPMER
Pondicherry
605006
Pondicherry
PONDICHERRY |
9037823770
eriyatvishnu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee (Human studies), JIPMER, PondicherryIEC Regn. No. ECR/342/Inst/PY/2013) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F312||Bipolar disorder, current episodemanic severe with psychotic features, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Manic phase of Bipolar disorder
Recieving sodium valproate |
|
| ExclusionCriteria |
| Details |
Recieving concomitant Lithium and Carbamazepine therapy, Substance abuse, organic mood disorder, seizure disorder
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical outcome measured with Young Mania Rating Scale score |
During admission period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adverse effects |
During admission period |
|
|
Target Sample Size
|
Total Sample Size="113"
Sample Size from India="113"
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)
|
01/11/2018 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Sodium valproate is a very commonly used Mood stabiliser in the indian tertiary care setting. Previous studies done on the serum concentration ranges of valproate that produces satisfactory clinical outcome has revealed conflicting information.Most of these studies have used assay methods, In this study we are using a standardised LCMS-MS method to ascertain the levels.The clinical outcome is measured by Young Mania Rating Scale and adverse effect will be noted down. Serum sample will be collected after patient is on valproate for atleast 5 days. The clinical outcome and advese effect will be correlated with the serum valproate levels.
Research question What is the serum valproate concentration range for satisfactory clinical outcome in patients with bipolar disorder treated with sodium valproate? |